M11_ProtocolSummary - XML Representation - Clinical Study Protocol v1.0.0-ballot2

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
Extension: M11_ProtocolSummary - XML Profile

Page standards status: Trial-use
Maturity Level: 2
XML representation of the m11-protocol-summary extension.
Raw xml | Download

<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="m11-protocol-summary"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition m11-protocol-summary</b></p><a name="m11-protocol-summary"> </a><a name="hcm11-protocol-summary"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension" title="Representation of summary of a study protocol.">Extension</a><a name="Extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Summary of a protocol</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension">extension</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">36..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> Slices for extension<a name="Extension.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:objectiveAndEstimandSummary" title="Slice objectiveAndEstimandSummary">extension:objectiveAndEstimandSummary</a><a name="Extension.extension.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:objectiveAndEstimandSummary.extension">extension</a><a name="Extension.extension.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:objectiveAndEstimandSummary.url">url</a><a name="Extension.extension.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;objectiveAndEstimandSummary&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: white; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:objectiveAndEstimandSummary.value[x]" title="A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.">value[x]</a><a name="Extension.extension.value_x_"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218839 Primary and Secondary Objectives and Estimands</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="markdown type: A string that may contain Github Flavored Markdown syntax for optional processing by a mark down presentation engine">valueMarkdown</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="string Type: A sequence of Unicode characters">valueString</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionModel" title="Slice interventionModel">extension:interventionModel</a><a name="Extension.extension.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionModel.extension">extension</a><a name="Extension.extension.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionModel.url">url</a><a name="Extension.extension.url.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;interventionModel&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionModel.value[x]" title="The overall design configuration for assigning intervention to participants.">value[x]</a><a name="Extension.extension.value_x_.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217277 Intervention Model<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-interventionModel-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs" class="binding">ICH M11 Intervention Model Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationType" title="Slice populationType">extension:populationType</a><a name="Extension.extension.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationType.extension">extension</a><a name="Extension.extension.extension.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationType.url">url</a><a name="Extension.extension.url.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;populationType&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationType.value[x]" title="A characterisation or classification of the trial population.">value[x]</a><a name="Extension.extension.value_x_.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217278 Population Type<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-populationType-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:controlType" title="Slice controlType">extension:controlType</a><a name="Extension.extension.6"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:controlType.extension">extension</a><a name="Extension.extension.extension.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:controlType.url">url</a><a name="Extension.extension.url.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;controlType&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:controlType.value[x]" title="A characterization or classification of the comparator against which the study intervention is evaluated.">value[x]</a><a name="Extension.extension.value_x_.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217279 Control Type<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-controlType-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationDiagnosisOrCondition" title="Slice populationDiagnosisOrCondition">extension:populationDiagnosisOrCondition</a><a name="Extension.extension.7"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:populationDiagnosisOrCondition.url">url</a><a name="Extension.extension.url.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;populationDiagnosisOrCondition&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:comparator" title="Slice comparator">extension:comparator</a><a name="Extension.extension.8"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:comparator.extension">extension</a><a name="Extension.extension.extension.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:comparator.url">url</a><a name="Extension.extension.url.6"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;comparator&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:comparator.value[x]" title="The comparator against which the study intervention is evaluated.">value[x]</a><a name="Extension.extension.value_x_.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/references.html">Reference</a>(<a href="http://hl7.org/fhir/R5/medicinalproductdefinition.html">MedicinalProductDefinition</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Comparator</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:minimumAge" title="Slice minimumAge">extension:minimumAge</a><a name="Extension.extension.9"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:minimumAge.extension">extension</a><a name="Extension.extension.extension.6"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:minimumAge.url">url</a><a name="Extension.extension.url.7"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;minimumAge&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:minimumAge.value[x]" title="The anticipated minimum age of the participants to be entered in a clinical trial.">value[x]</a><a name="Extension.extension.value_x_.6"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C49693/C25301 Minimum Age value/units</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:unitsOfMinimumAge" title="Slice unitsOfMinimumAge">extension:unitsOfMinimumAge</a><a name="Extension.extension.10"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:unitsOfMinimumAge.url">url</a><a name="Extension.extension.url.8"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;unitsOfMinimumAge&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:maximumAge" title="Slice maximumAge">extension:maximumAge</a><a name="Extension.extension.11"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:maximumAge.extension">extension</a><a name="Extension.extension.extension.7"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:maximumAge.url">url</a><a name="Extension.extension.url.9"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;maximumAge&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:maximumAge.value[x]" title="The anticipated maximum age of the participants to be entered in a clinical trial.">value[x]</a><a name="Extension.extension.value_x_.7"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Quantity">Quantity</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C49694/C25301 Minimum Age value/units</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:unitsOfMaximumAge" title="Slice unitsOfMaximumAge">extension:unitsOfMaximumAge</a><a name="Extension.extension.12"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:unitsOfMaximumAge.url">url</a><a name="Extension.extension.url.10"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;unitsOfMaximumAge&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionAssignmentMethod" title="Slice interventionAssignmentMethod">extension:interventionAssignmentMethod</a><a name="Extension.extension.13"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionAssignmentMethod.extension">extension</a><a name="Extension.extension.extension.8"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionAssignmentMethod.url">url</a><a name="Extension.extension.url.11"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;interventionAssignmentMethod&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:interventionAssignmentMethod.value[x]" title="The process used to assign trial participants to a trial intervention or trial arm.">value[x]</a><a name="Extension.extension.value_x_.8"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"> C217280 Intervention Assignment Method<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-interventionAssignmentMethod-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:randomisationType" title="Slice randomisationType">extension:randomisationType</a><a name="Extension.extension.14"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:randomisationType.extension">extension</a><a name="Extension.extension.extension.9"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:randomisationType.url">url</a><a name="Extension.extension.url.12"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;randomisationType&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: white; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:randomisationType.value[x]" title="The type of randomisation to be used (e.g., simple randomisation, block randomisation)">value[x]</a><a name="Extension.extension.value_x_.9"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C223137 Randomisation Type</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13410.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <span title="string Type: A sequence of Unicode characters">valueString</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13400.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="CodeableConcept Type: A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.">valueCodeableConcept</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherInterventionAssignmentMethod" title="Slice otherInterventionAssignmentMethod">extension:otherInterventionAssignmentMethod</a><a name="Extension.extension.15"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherInterventionAssignmentMethod.extension">extension</a><a name="Extension.extension.extension.10"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherInterventionAssignmentMethod.url">url</a><a name="Extension.extension.url.13"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;otherInterventionAssignmentMethod&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherInterventionAssignmentMethod.value[x]" title="If applicable, describe the other intervention assignment method.">value[x]</a><a name="Extension.extension.value_x_.10"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C223138 Other Intervention Assignment Method}</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:stratificationIndicator" title="Slice stratificationIndicator">extension:stratificationIndicator</a><a name="Extension.extension.16"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:stratificationIndicator.extension">extension</a><a name="Extension.extension.extension.11"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:stratificationIndicator.url">url</a><a name="Extension.extension.url.14"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;stratificationIndicator&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:stratificationIndicator.value[x]">value[x]</a><a name="Extension.extension.value_x_.11"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C223136 Stratification Indicator<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-yes-no-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs" class="binding">ICH M11 No Yes Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteDistribution" title="Slice siteDistribution">extension:siteDistribution</a><a name="Extension.extension.17"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteDistribution.extension">extension</a><a name="Extension.extension.extension.12"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteDistribution.url">url</a><a name="Extension.extension.url.15"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;siteDistribution&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteDistribution.value[x]" title="An indication as to whether the occurrence applies to a single or multiple trial sites.">value[x]</a><a name="Extension.extension.value_x_.12"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"> C217049 Site Distribution<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-siteDistribution-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteGeographicScope" title="Slice siteGeographicScope">extension:siteGeographicScope</a><a name="Extension.extension.18"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteGeographicScope.extension">extension</a><a name="Extension.extension.extension.13"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteGeographicScope.url">url</a><a name="Extension.extension.url.16"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;siteGeographicScope&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:siteGeographicScope.value[x]" title="An indication as to whether the trial is taking place in one or more countries.">value[x]</a><a name="Extension.extension.value_x_.13"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217050: Site geographic scope<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-siteGeographicscope-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:masterProtocolIndicator" title="Slice masterProtocolIndicator">extension:masterProtocolIndicator</a><a name="Extension.extension.19"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:masterProtocolIndicator.extension">extension</a><a name="Extension.extension.extension.14"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:masterProtocolIndicator.url">url</a><a name="Extension.extension.url.17"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;masterProtocolIndicator&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:masterProtocolIndicator.value[x]" title="An indication as to whether the protocol is a master protocol.">value[x]</a><a name="Extension.extension.value_x_.14"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217046 Master Protocol Indicator<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-yes-no-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs" class="binding">ICH M11 No Yes Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:drug-DeviceCombinationProductIndicator" title="Slice drug-DeviceCombinationProductIndicator">extension:drug-DeviceCombinationProductIndicator</a><a name="Extension.extension.20"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:drug-DeviceCombinationProductIndicator.extension">extension</a><a name="Extension.extension.extension.15"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:drug-DeviceCombinationProductIndicator.url">url</a><a name="Extension.extension.url.18"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;drug-DeviceCombinationProductIndicator&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:drug-DeviceCombinationProductIndicator.value[x]" title="An indication as to whether the clinical trial is testing a drug-device combination product.">value[x]</a><a name="Extension.extension.value_x_.15"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217046 Drug-Device Combination Product Indicator<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-yes-no-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs" class="binding">ICH M11 No Yes Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:adaptiveTrialDesignIndicator" title="Slice adaptiveTrialDesignIndicator">extension:adaptiveTrialDesignIndicator</a><a name="Extension.extension.21"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:adaptiveTrialDesignIndicator.extension">extension</a><a name="Extension.extension.extension.16"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:adaptiveTrialDesignIndicator.url">url</a><a name="Extension.extension.url.19"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;adaptiveTrialDesignIndicator&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:adaptiveTrialDesignIndicator.value[x]" title="An indication as to whether the clinical trial uses an adaptive trial design.">value[x]</a><a name="Extension.extension.value_x_.16"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217046 Adaptive Trial Design Indicator<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-yes-no-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs" class="binding">ICH M11 No Yes Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfArms" title="Slice numberOfArms">extension:numberOfArms</a><a name="Extension.extension.22"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfArms.extension">extension</a><a name="Extension.extension.extension.17"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfArms.url">url</a><a name="Extension.extension.url.20"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;numberOfArms&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfArms.value[x]" title="The planned number of intervention groups.">value[x]</a><a name="Extension.extension.value_x_.17"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#integer">integer</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C98771 Number of Arms</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialBlindSchema" title="Slice trialBlindSchema">extension:trialBlindSchema</a><a name="Extension.extension.23"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialBlindSchema.extension">extension</a><a name="Extension.extension.extension.18"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialBlindSchema.url">url</a><a name="Extension.extension.url.21"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;trialBlindSchema&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialBlindSchema.value[x]" title="The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.">value[x]</a><a name="Extension.extension.value_x_.18"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217051 Trial Blind Schema<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-trialBlindSchema-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:blindedRoles" title="Slice blindedRoles">extension:blindedRoles</a><a name="Extension.extension.24"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:blindedRoles.extension">extension</a><a name="Extension.extension.extension.19"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:blindedRoles.url">url</a><a name="Extension.extension.url.22"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;blindedRoles&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:blindedRoles.value[x]" title="An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function">value[x]</a><a name="Extension.extension.value_x_.19"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217281: Blinded Roles<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-blindedRoles-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:targetOrMaximum" title="Slice targetOrMaximum">extension:targetOrMaximum</a><a name="Extension.extension.25"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:targetOrMaximum.extension">extension</a><a name="Extension.extension.extension.20"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:targetOrMaximum.url">url</a><a name="Extension.extension.url.23"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;targetOrMaximum&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:targetOrMaximum.value[x]" title="A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.">value[x]</a><a name="Extension.extension.value_x_.20"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Target-Maximum<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-target-Maximum-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs" class="binding">UDP ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfParticipants" title="Slice numberOfParticipants">extension:numberOfParticipants</a><a name="Extension.extension.26"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfParticipants.extension">extension</a><a name="Extension.extension.extension.21"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfParticipants.url">url</a><a name="Extension.extension.url.24"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;numberOfParticipants&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:numberOfParticipants.value[x]" title="The planned number of participant be entered in a clinical trial.">value[x]</a><a name="Extension.extension.value_x_.21"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#integer">integer</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C49692 Number of Participants</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialIntervention" title="Slice totalPlannedDurationOfTrialIntervention">extension:totalPlannedDurationOfTrialIntervention</a><a name="Extension.extension.27"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialIntervention.extension">extension</a><a name="Extension.extension.extension.22"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialIntervention.url">url</a><a name="Extension.extension.url.25"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;totalPlannedDurationOfTrialIntervention&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]" title="The total planned duration of trial intervention">value[x]</a><a name="Extension.extension.value_x_.22"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#time">time</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218712/C218713 total planned duration of trial intervention value/units</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime" title="Slice totalPlannedDurationOfTrialInterventionUnitOfTime">extension:totalPlannedDurationOfTrialInterventionUnitOfTime</a><a name="Extension.extension.28"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url">url</a><a name="Extension.extension.url.26"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;totalPlannedDurationOfTrialInterventionUnitOfTime&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention" title="Slice alternateDescriptionOfPlannedDurationOfTrialIntervention">extension:alternateDescriptionOfPlannedDurationOfTrialIntervention</a><a name="Extension.extension.29"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension">extension</a><a name="Extension.extension.extension.23"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url">url</a><a name="Extension.extension.url.27"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;alternateDescriptionOfPlannedDurationOfTrialIntervention&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]" title="An alternative textual narrative for the planned duration of trial intervention.">value[x]</a><a name="Extension.extension.value_x_.23"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218714 alternate description of planned duration of trial intervention if duration will vary</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipation" title="Slice totalPlannedDurationOfTrialParticipation">extension:totalPlannedDurationOfTrialParticipation</a><a name="Extension.extension.30"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipation.extension">extension</a><a name="Extension.extension.extension.24"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipation.url">url</a><a name="Extension.extension.url.28"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;totalPlannedDurationOfTrialParticipation&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]" title="The total planned duration of trial participation">value[x]</a><a name="Extension.extension.value_x_.24"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#time">time</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"> C218715/C218716 total planned duration of trial participation value/units</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime" title="Slice totalPlannedDurationOfTrialParticipationUnitOfTime">extension:totalPlannedDurationOfTrialParticipationUnitOfTime</a><a name="Extension.extension.31"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url">url</a><a name="Extension.extension.url.29"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;totalPlannedDurationOfTrialParticipationUnitOfTime&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation" title="Slice alternateDescriptionOfPlannedDurationOfTrialParticipation">extension:alternateDescriptionOfPlannedDurationOfTrialParticipation</a><a name="Extension.extension.32"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension">extension</a><a name="Extension.extension.extension.25"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url">url</a><a name="Extension.extension.url.30"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;alternateDescriptionOfPlannedDurationOfTrialParticipation&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]" title="An alternative narrative for the planned duration of trial participation.">value[x]</a><a name="Extension.extension.value_x_.25"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218717 alternate description of planned duration of trial participation if duration will vary</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:additionalDescriptionofDuration" title="Slice additionalDescriptionofDuration">extension:additionalDescriptionofDuration</a><a name="Extension.extension.33"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:additionalDescriptionofDuration.extension">extension</a><a name="Extension.extension.extension.26"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:additionalDescriptionofDuration.url">url</a><a name="Extension.extension.url.31"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;additionalDescriptionofDuration&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:additionalDescriptionofDuration.value[x]" title="A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.">value[x]</a><a name="Extension.extension.value_x_.26"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218838 Additional Description of Duration</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:independentCommittees" title="Slice independentCommittees">extension:independentCommittees</a><a name="Extension.extension.34"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:independentCommittees.extension">extension</a><a name="Extension.extension.extension.27"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:independentCommittees.url">url</a><a name="Extension.extension.url.32"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;independentCommittees&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:independentCommittees.value[x]" title="An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.">value[x]</a><a name="Extension.extension.value_x_.27"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C217282 Independent Committees<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-independentCommittees-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs" class="binding">ICH M11 ...</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherCommittees" title="Slice otherCommittees">extension:otherCommittees</a><a name="Extension.extension.35"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherCommittees.extension">extension</a><a name="Extension.extension.extension.28"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherCommittees.url">url</a><a name="Extension.extension.url.33"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;otherCommittees&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:otherCommittees.value[x]" title="A committee that is different than the one(s) previously specified or mentioned.">value[x]</a><a name="Extension.extension.value_x_.28"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218719 Other Committees</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialSchema" title="Slice trialSchema">extension:trialSchema</a><a name="Extension.extension.36"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialSchema.extension">extension</a><a name="Extension.extension.extension.29"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialSchema.url">url</a><a name="Extension.extension.url.34"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;trialSchema&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:trialSchema.value[x]" title="A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.">value[x]</a><a name="Extension.extension.value_x_.29"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C93682 Trial Schema</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:schemaNotes" title="Slice schemaNotes">extension:schemaNotes</a><a name="Extension.extension.37"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:schemaNotes.extension">extension</a><a name="Extension.extension.extension.30"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:schemaNotes.url">url</a><a name="Extension.extension.url.35"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;schemaNotes&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:schemaNotes.value[x]" title="A brief written record describing the trial schematic.">value[x]</a><a name="Extension.extension.value_x_.30"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C218720 Schema Notes</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:scheduleofActivities" title="Slice scheduleofActivities">extension:scheduleofActivities</a><a name="Extension.extension.38"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/6.0.0-ballot3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:scheduleofActivities.extension">extension</a><a name="Extension.extension.extension.31"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:scheduleofActivities.url">url</a><a name="Extension.extension.url.36"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;scheduleofActivities&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.extension:scheduleofActivities.value[x]" title="The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.">value[x]</a><a name="Extension.extension.value_x_.31"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">C132349 Schedule of Activities</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.url">url</a><a name="Extension.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary&quot;</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-m11-protocol-summary-definitions.html#Extension.value[x]">value[x]</a><a name="Extension.value_x_"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Value of extension</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
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    <valueCode value="can-bind"/>
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    <valueCode value="brr"/>
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  <url
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  <name value="M11_ProtocolSummary"/>
  <status value="active"/>
  <date value="2026-06-04T16:52:10+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
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    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
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  </contact>
  <description value="Summary to a protocol."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright
             value="Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. 
The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. 

CDISC publishes semantics for the ICH M11 protocol data elements and valid 
value sets. This terminology set is published and stored in the NCI Thesaurus 
Subset C217023 - ICH M11 Terminology 
(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) 

The NCI Thesaurus is released under the CC BY 4.0 license

CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license

For more licensing information and links see: [licenses.html](licenses.html)"/>
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      <definition value="Representation of summary of a study protocol."/>
      <comment
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      <short value="Extension"/>
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      <min value="36"/>
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        <path value="Element.extension"/>
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      <short value="Extension"/>
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      <short value="identifies the meaning of the extension"/>
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      <comment
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      <min value="1"/>
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        <path value="Extension.url"/>
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      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:interventionModel.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:interventionModel.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="interventionModel"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:interventionModel.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217277 Intervention Model"/>
      <definition
                  value="The overall design configuration for assigning intervention to participants."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:populationType">
      <path value="Extension.extension"/>
      <sliceName value="populationType"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:populationType.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:populationType.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:populationType.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="populationType"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:populationType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217278 Population Type"/>
      <definition
                  value="A characterisation or classification of the trial population."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:controlType">
      <path value="Extension.extension"/>
      <sliceName value="controlType"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:controlType.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:controlType.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:controlType.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="controlType"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:controlType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217279 Control Type"/>
      <definition
                  value="A characterization or classification of the comparator against which the study intervention is evaluated."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:populationDiagnosisOrCondition">
      <path value="Extension.extension"/>
      <sliceName value="populationDiagnosisOrCondition"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:populationDiagnosisOrCondition.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:populationDiagnosisOrCondition.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:populationDiagnosisOrCondition.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="populationDiagnosisOrCondition"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:populationDiagnosisOrCondition.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:comparator">
      <path value="Extension.extension"/>
      <sliceName value="comparator"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:comparator.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:comparator.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:comparator.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="comparator"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:comparator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Comparator"/>
      <definition
                  value="The comparator against which the study intervention is evaluated."/>
      <comment
               value="M11 CC97054 requires on a narrative representation of the comparator - the name."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:minimumAge">
      <path value="Extension.extension"/>
      <sliceName value="minimumAge"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:minimumAge.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:minimumAge.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:minimumAge.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="minimumAge"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:minimumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49693/C25301 Minimum Age value/units"/>
      <definition
                  value="The anticipated minimum age of the participants to be entered in a clinical trial."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge">
      <path value="Extension.extension"/>
      <sliceName value="unitsOfMinimumAge"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="unitsOfMinimumAge"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:maximumAge">
      <path value="Extension.extension"/>
      <sliceName value="maximumAge"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:maximumAge.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:maximumAge.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:maximumAge.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="maximumAge"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:maximumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49694/C25301 Minimum Age value/units"/>
      <definition
                  value="The anticipated maximum age of the participants to be entered in a clinical trial."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge">
      <path value="Extension.extension"/>
      <sliceName value="unitsOfMaximumAge"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="unitsOfMaximumAge"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod">
      <path value="Extension.extension"/>
      <sliceName value="interventionAssignmentMethod"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="interventionAssignmentMethod"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value=" C217280 Intervention Assignment Method"/>
      <definition
                  value="The process used to assign trial participants to a trial intervention or trial arm."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:randomisationType">
      <path value="Extension.extension"/>
      <sliceName value="randomisationType"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:randomisationType.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:randomisationType.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:randomisationType.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="randomisationType"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:randomisationType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223137 Randomisation Type"/>
      <definition
                  value="The type of randomisation to be used (e.g., simple randomisation, block randomisation)"/>
      <comment
               value="this is just a text description - implementers may want to provide a value set that tehe text can be drawn from."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:otherInterventionAssignmentMethod">
      <path value="Extension.extension"/>
      <sliceName value="otherInterventionAssignmentMethod"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:otherInterventionAssignmentMethod.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:otherInterventionAssignmentMethod.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:otherInterventionAssignmentMethod.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="otherInterventionAssignmentMethod"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:otherInterventionAssignmentMethod.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223138 Other Intervention Assignment Method}"/>
      <definition
                  value="If applicable, describe the other intervention assignment method."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:stratificationIndicator">
      <path value="Extension.extension"/>
      <sliceName value="stratificationIndicator"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:stratificationIndicator.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:stratificationIndicator.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:stratificationIndicator.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="stratificationIndicator"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:stratificationIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223136 Stratification Indicator"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteDistribution">
      <path value="Extension.extension"/>
      <sliceName value="siteDistribution"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:siteDistribution.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteDistribution.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:siteDistribution.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="siteDistribution"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteDistribution.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value=" C217049 Site Distribution"/>
      <definition
                  value="An indication as to whether the occurrence applies to a single or multiple trial sites."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteGeographicScope">
      <path value="Extension.extension"/>
      <sliceName value="siteGeographicScope"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:siteGeographicScope.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteGeographicScope.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:siteGeographicScope.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="siteGeographicScope"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:siteGeographicScope.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217050: Site geographic scope"/>
      <definition
                  value="An indication as to whether the trial is taking place in one or more countries."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:masterProtocolIndicator">
      <path value="Extension.extension"/>
      <sliceName value="masterProtocolIndicator"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="masterProtocolIndicator"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Master Protocol Indicator"/>
      <definition
                  value="An indication as to whether the protocol is a master protocol."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:drug-DeviceCombinationProductIndicator">
      <path value="Extension.extension"/>
      <sliceName value="drug-DeviceCombinationProductIndicator"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="drug-DeviceCombinationProductIndicator"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Drug-Device Combination Product Indicator"/>
      <definition
                  value="An indication as to whether the clinical trial is testing a drug-device combination product."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator">
      <path value="Extension.extension"/>
      <sliceName value="adaptiveTrialDesignIndicator"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="adaptiveTrialDesignIndicator"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Adaptive Trial Design Indicator"/>
      <definition
                  value="An indication as to whether the clinical trial uses an adaptive trial design."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfArms">
      <path value="Extension.extension"/>
      <sliceName value="numberOfArms"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:numberOfArms.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfArms.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:numberOfArms.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="numberOfArms"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfArms.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C98771 Number of Arms"/>
      <definition value="The planned number of intervention groups."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="integer"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialBlindSchema">
      <path value="Extension.extension"/>
      <sliceName value="trialBlindSchema"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:trialBlindSchema.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialBlindSchema.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:trialBlindSchema.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="trialBlindSchema"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialBlindSchema.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217051 Trial Blind Schema"/>
      <definition
                  value="The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:blindedRoles">
      <path value="Extension.extension"/>
      <sliceName value="blindedRoles"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:blindedRoles.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:blindedRoles.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:blindedRoles.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="blindedRoles"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:blindedRoles.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217281: Blinded Roles"/>
      <definition
                  value="An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:targetOrMaximum">
      <path value="Extension.extension"/>
      <sliceName value="targetOrMaximum"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:targetOrMaximum.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:targetOrMaximum.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:targetOrMaximum.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="targetOrMaximum"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:targetOrMaximum.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Target-Maximum"/>
      <definition
                  value="A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum."/>
      <comment
               value="The ICH spec has this as optional boilerplate text but it has to be a variable to be processable"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfParticipants">
      <path value="Extension.extension"/>
      <sliceName value="numberOfParticipants"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:numberOfParticipants.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfParticipants.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:numberOfParticipants.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="numberOfParticipants"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:numberOfParticipants.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49692 Number of Participants"/>
      <definition
                  value="The planned number of participant be entered in a clinical trial."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="integer"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialIntervention"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="totalPlannedDurationOfTrialIntervention"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218712/C218713 total planned duration of trial intervention value/units"/>
      <definition value="The total planned duration of trial intervention"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="time"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialInterventionUnitOfTime"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="totalPlannedDurationOfTrialInterventionUnitOfTime"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention">
      <path value="Extension.extension"/>
      <sliceName
                 value="alternateDescriptionOfPlannedDurationOfTrialIntervention"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri
                value="alternateDescriptionOfPlannedDurationOfTrialIntervention"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218714 alternate description of planned duration of trial intervention if duration will vary"/>
      <definition
                  value="An alternative textual narrative for the planned duration of trial intervention."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialParticipation"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="totalPlannedDurationOfTrialParticipation"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value=" C218715/C218716 total planned duration of trial participation value/units"/>
      <definition value="The total planned duration of trial participation"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="time"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialParticipationUnitOfTime"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="totalPlannedDurationOfTrialParticipationUnitOfTime"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation">
      <path value="Extension.extension"/>
      <sliceName
                 value="alternateDescriptionOfPlannedDurationOfTrialParticipation"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri
                value="alternateDescriptionOfPlannedDurationOfTrialParticipation"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218717 alternate description of planned duration of trial participation if duration will vary"/>
      <definition
                  value="An alternative narrative for the planned duration of trial participation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:additionalDescriptionofDuration">
      <path value="Extension.extension"/>
      <sliceName value="additionalDescriptionofDuration"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:additionalDescriptionofDuration.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:additionalDescriptionofDuration.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:additionalDescriptionofDuration.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="additionalDescriptionofDuration"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element
             id="Extension.extension:additionalDescriptionofDuration.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218838 Additional Description of Duration"/>
      <definition
                  value="A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:independentCommittees">
      <path value="Extension.extension"/>
      <sliceName value="independentCommittees"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:independentCommittees.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:independentCommittees.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:independentCommittees.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="independentCommittees"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:independentCommittees.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217282 Independent Committees"/>
      <definition
                  value="An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:otherCommittees">
      <path value="Extension.extension"/>
      <sliceName value="otherCommittees"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:otherCommittees.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:otherCommittees.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:otherCommittees.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="otherCommittees"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:otherCommittees.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218719 Other Committees"/>
      <definition
                  value="A committee that is different than the one(s) previously specified or mentioned."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialSchema">
      <path value="Extension.extension"/>
      <sliceName value="trialSchema"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:trialSchema.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialSchema.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:trialSchema.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="trialSchema"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:trialSchema.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C93682 Trial Schema"/>
      <definition
                  value="A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:schemaNotes">
      <path value="Extension.extension"/>
      <sliceName value="schemaNotes"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:schemaNotes.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:schemaNotes.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:schemaNotes.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="schemaNotes"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:schemaNotes.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218720 Schema Notes"/>
      <definition
                  value="A brief written record describing the trial schematic."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scheduleofActivities">
      <path value="Extension.extension"/>
      <sliceName value="scheduleofActivities"/>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scheduleofActivities.id">
      <path value="Extension.extension.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <condition value="ele-1"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Extension.extension:scheduleofActivities.extension">
      <path value="Extension.extension.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Extension.extension:scheduleofActivities.url">
      <path value="Extension.extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri value="scheduleofActivities"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.extension:scheduleofActivities.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C132349 Schedule of Activities"/>
      <definition
                  value="The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.url">
      <path value="Extension.url"/>
      <representation value="xmlAttr"/>
      <short value="identifies the meaning of the extension"/>
      <definition
                  value="Source of the definition for the extension code - a logical name or a URL."/>
      <comment
               value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Extension.url"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="uri"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <fixedUri
                value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Extension.value[x]">
      <path value="Extension.value[x]"/>
      <short value="Value of extension"/>
      <definition
                  value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list)."/>
      <min value="0"/>
      <max value="0"/>
      <base>
        <path value="Extension.value[x]"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <type>
        <code value="boolean"/>
      </type>
      <type>
        <code value="canonical"/>
      </type>
      <type>
        <code value="code"/>
      </type>
      <type>
        <code value="date"/>
      </type>
      <type>
        <code value="dateTime"/>
      </type>
      <type>
        <code value="decimal"/>
      </type>
      <type>
        <code value="id"/>
      </type>
      <type>
        <code value="instant"/>
      </type>
      <type>
        <code value="integer"/>
      </type>
      <type>
        <code value="integer64"/>
      </type>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="oid"/>
      </type>
      <type>
        <code value="positiveInt"/>
      </type>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="time"/>
      </type>
      <type>
        <code value="unsignedInt"/>
      </type>
      <type>
        <code value="uri"/>
      </type>
      <type>
        <code value="url"/>
      </type>
      <type>
        <code value="uuid"/>
      </type>
      <type>
        <code value="Address"/>
      </type>
      <type>
        <code value="Age"/>
      </type>
      <type>
        <code value="Annotation"/>
      </type>
      <type>
        <code value="Attachment"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <type>
        <code value="CodeableReference"/>
      </type>
      <type>
        <code value="Coding"/>
      </type>
      <type>
        <code value="ContactPoint"/>
      </type>
      <type>
        <code value="Count"/>
      </type>
      <type>
        <code value="Distance"/>
      </type>
      <type>
        <code value="Duration"/>
      </type>
      <type>
        <code value="HumanName"/>
      </type>
      <type>
        <code value="Identifier"/>
      </type>
      <type>
        <code value="Money"/>
      </type>
      <type>
        <code value="Period"/>
      </type>
      <type>
        <code value="Quantity"/>
      </type>
      <type>
        <code value="Range"/>
      </type>
      <type>
        <code value="Ratio"/>
      </type>
      <type>
        <code value="RatioRange"/>
      </type>
      <type>
        <code value="Reference"/>
      </type>
      <type>
        <code value="SampledData"/>
      </type>
      <type>
        <code value="Signature"/>
      </type>
      <type>
        <code value="Timing"/>
      </type>
      <type>
        <code value="ContactDetail"/>
      </type>
      <type>
        <code value="DataRequirement"/>
      </type>
      <type>
        <code value="Expression"/>
      </type>
      <type>
        <code value="ParameterDefinition"/>
      </type>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <type>
        <code value="TriggerDefinition"/>
      </type>
      <type>
        <code value="UsageContext"/>
      </type>
      <type>
        <code value="Availability"/>
      </type>
      <type>
        <code value="ExtendedContactDetail"/>
      </type>
      <type>
        <code value="Dosage"/>
      </type>
      <type>
        <code value="Meta"/>
      </type>
      <condition value="ext-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
  </snapshot>
  <differential>
    <element id="Extension">
      <path value="Extension"/>
      <short value="Summary of a protocol"/>
      <definition value="Representation of summary of a study protocol."/>
      <comment
               value="This is Section 1 of the ICH Technical Summary and Guideline."/>
    </element>
    <element id="Extension.extension">
      <path value="Extension.extension"/>
      <min value="36"/>
    </element>
    <element id="Extension.extension:objectiveAndEstimandSummary">
      <path value="Extension.extension"/>
      <sliceName value="objectiveAndEstimandSummary"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:objectiveAndEstimandSummary.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:objectiveAndEstimandSummary.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="objectiveAndEstimandSummary"/>
    </element>
    <element id="Extension.extension:objectiveAndEstimandSummary.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218839 Primary and Secondary Objectives and Estimands"/>
      <definition
                  value="A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial."/>
      <type>
        <code value="markdown"/>
      </type>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:interventionModel">
      <path value="Extension.extension"/>
      <sliceName value="interventionModel"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:interventionModel.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:interventionModel.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="interventionModel"/>
    </element>
    <element id="Extension.extension:interventionModel.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217277 Intervention Model"/>
      <definition
                  value="The overall design configuration for assigning intervention to participants."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionModel-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:populationType">
      <path value="Extension.extension"/>
      <sliceName value="populationType"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:populationType.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:populationType.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="populationType"/>
    </element>
    <element id="Extension.extension:populationType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217278 Population Type"/>
      <definition
                  value="A characterisation or classification of the trial population."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-populationType-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:controlType">
      <path value="Extension.extension"/>
      <sliceName value="controlType"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:controlType.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:controlType.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="controlType"/>
    </element>
    <element id="Extension.extension:controlType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217279 Control Type"/>
      <definition
                  value="A characterization or classification of the comparator against which the study intervention is evaluated."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-controlType-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:populationDiagnosisOrCondition">
      <path value="Extension.extension"/>
      <sliceName value="populationDiagnosisOrCondition"/>
      <min value="1"/>
      <max value="*"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:populationDiagnosisOrCondition.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="populationDiagnosisOrCondition"/>
    </element>
    <element id="Extension.extension:comparator">
      <path value="Extension.extension"/>
      <sliceName value="comparator"/>
      <min value="1"/>
      <max value="*"/>
    </element>
    <element id="Extension.extension:comparator.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:comparator.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="comparator"/>
    </element>
    <element id="Extension.extension:comparator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Comparator"/>
      <definition
                  value="The comparator against which the study intervention is evaluated."/>
      <comment
               value="M11 CC97054 requires on a narrative representation of the comparator - the name."/>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>
      </type>
    </element>
    <element id="Extension.extension:minimumAge">
      <path value="Extension.extension"/>
      <sliceName value="minimumAge"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:minimumAge.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:minimumAge.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="minimumAge"/>
    </element>
    <element id="Extension.extension:minimumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49693/C25301 Minimum Age value/units"/>
      <definition
                  value="The anticipated minimum age of the participants to be entered in a clinical trial."/>
      <type>
        <code value="Quantity"/>
      </type>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge">
      <path value="Extension.extension"/>
      <sliceName value="unitsOfMinimumAge"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:unitsOfMinimumAge.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="unitsOfMinimumAge"/>
    </element>
    <element id="Extension.extension:maximumAge">
      <path value="Extension.extension"/>
      <sliceName value="maximumAge"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:maximumAge.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:maximumAge.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="maximumAge"/>
    </element>
    <element id="Extension.extension:maximumAge.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49694/C25301 Minimum Age value/units"/>
      <definition
                  value="The anticipated maximum age of the participants to be entered in a clinical trial."/>
      <type>
        <code value="Quantity"/>
      </type>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge">
      <path value="Extension.extension"/>
      <sliceName value="unitsOfMaximumAge"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:unitsOfMaximumAge.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="unitsOfMaximumAge"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod">
      <path value="Extension.extension"/>
      <sliceName value="interventionAssignmentMethod"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="interventionAssignmentMethod"/>
    </element>
    <element id="Extension.extension:interventionAssignmentMethod.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value=" C217280 Intervention Assignment Method"/>
      <definition
                  value="The process used to assign trial participants to a trial intervention or trial arm."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-interventionAssignmentMethod-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:randomisationType">
      <path value="Extension.extension"/>
      <sliceName value="randomisationType"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:randomisationType.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:randomisationType.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="randomisationType"/>
    </element>
    <element id="Extension.extension:randomisationType.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223137 Randomisation Type"/>
      <definition
                  value="The type of randomisation to be used (e.g., simple randomisation, block randomisation)"/>
      <comment
               value="this is just a text description - implementers may want to provide a value set that tehe text can be drawn from."/>
      <type>
        <code value="string"/>
      </type>
      <type>
        <code value="CodeableConcept"/>
      </type>
    </element>
    <element id="Extension.extension:otherInterventionAssignmentMethod">
      <path value="Extension.extension"/>
      <sliceName value="otherInterventionAssignmentMethod"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="Extension.extension:otherInterventionAssignmentMethod.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:otherInterventionAssignmentMethod.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="otherInterventionAssignmentMethod"/>
    </element>
    <element
             id="Extension.extension:otherInterventionAssignmentMethod.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223138 Other Intervention Assignment Method}"/>
      <definition
                  value="If applicable, describe the other intervention assignment method."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:stratificationIndicator">
      <path value="Extension.extension"/>
      <sliceName value="stratificationIndicator"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:stratificationIndicator.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:stratificationIndicator.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="stratificationIndicator"/>
    </element>
    <element id="Extension.extension:stratificationIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C223136 Stratification Indicator"/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:siteDistribution">
      <path value="Extension.extension"/>
      <sliceName value="siteDistribution"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:siteDistribution.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:siteDistribution.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="siteDistribution"/>
    </element>
    <element id="Extension.extension:siteDistribution.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value=" C217049 Site Distribution"/>
      <definition
                  value="An indication as to whether the occurrence applies to a single or multiple trial sites."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteDistribution-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:siteGeographicScope">
      <path value="Extension.extension"/>
      <sliceName value="siteGeographicScope"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:siteGeographicScope.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:siteGeographicScope.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="siteGeographicScope"/>
    </element>
    <element id="Extension.extension:siteGeographicScope.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217050: Site geographic scope"/>
      <definition
                  value="An indication as to whether the trial is taking place in one or more countries."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-siteGeographicscope-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:masterProtocolIndicator">
      <path value="Extension.extension"/>
      <sliceName value="masterProtocolIndicator"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="masterProtocolIndicator"/>
    </element>
    <element id="Extension.extension:masterProtocolIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Master Protocol Indicator"/>
      <definition
                  value="An indication as to whether the protocol is a master protocol."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:drug-DeviceCombinationProductIndicator">
      <path value="Extension.extension"/>
      <sliceName value="drug-DeviceCombinationProductIndicator"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="drug-DeviceCombinationProductIndicator"/>
    </element>
    <element
             id="Extension.extension:drug-DeviceCombinationProductIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Drug-Device Combination Product Indicator"/>
      <definition
                  value="An indication as to whether the clinical trial is testing a drug-device combination product."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator">
      <path value="Extension.extension"/>
      <sliceName value="adaptiveTrialDesignIndicator"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="adaptiveTrialDesignIndicator"/>
    </element>
    <element id="Extension.extension:adaptiveTrialDesignIndicator.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217046 Adaptive Trial Design Indicator"/>
      <definition
                  value="An indication as to whether the clinical trial uses an adaptive trial design."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:numberOfArms">
      <path value="Extension.extension"/>
      <sliceName value="numberOfArms"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:numberOfArms.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:numberOfArms.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="numberOfArms"/>
    </element>
    <element id="Extension.extension:numberOfArms.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C98771 Number of Arms"/>
      <definition value="The planned number of intervention groups."/>
      <type>
        <code value="integer"/>
      </type>
    </element>
    <element id="Extension.extension:trialBlindSchema">
      <path value="Extension.extension"/>
      <sliceName value="trialBlindSchema"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:trialBlindSchema.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:trialBlindSchema.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="trialBlindSchema"/>
    </element>
    <element id="Extension.extension:trialBlindSchema.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217051 Trial Blind Schema"/>
      <definition
                  value="The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-trialBlindSchema-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:blindedRoles">
      <path value="Extension.extension"/>
      <sliceName value="blindedRoles"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:blindedRoles.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:blindedRoles.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="blindedRoles"/>
    </element>
    <element id="Extension.extension:blindedRoles.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217281: Blinded Roles"/>
      <definition
                  value="An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function"/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:targetOrMaximum">
      <path value="Extension.extension"/>
      <sliceName value="targetOrMaximum"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:targetOrMaximum.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:targetOrMaximum.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="targetOrMaximum"/>
    </element>
    <element id="Extension.extension:targetOrMaximum.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="Target-Maximum"/>
      <definition
                  value="A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum."/>
      <comment
               value="The ICH spec has this as optional boilerplate text but it has to be a variable to be processable"/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-target-Maximum-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:numberOfParticipants">
      <path value="Extension.extension"/>
      <sliceName value="numberOfParticipants"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:numberOfParticipants.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:numberOfParticipants.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="numberOfParticipants"/>
    </element>
    <element id="Extension.extension:numberOfParticipants.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C49692 Number of Participants"/>
      <definition
                  value="The planned number of participant be entered in a clinical trial."/>
      <type>
        <code value="integer"/>
      </type>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialIntervention"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="totalPlannedDurationOfTrialIntervention"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialIntervention.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218712/C218713 total planned duration of trial intervention value/units"/>
      <definition value="The total planned duration of trial intervention"/>
      <type>
        <code value="time"/>
      </type>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialInterventionUnitOfTime"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialInterventionUnitOfTime.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="totalPlannedDurationOfTrialInterventionUnitOfTime"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention">
      <path value="Extension.extension"/>
      <sliceName
                 value="alternateDescriptionOfPlannedDurationOfTrialIntervention"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.url">
      <path value="Extension.extension.url"/>
      <fixedUri
                value="alternateDescriptionOfPlannedDurationOfTrialIntervention"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialIntervention.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218714 alternate description of planned duration of trial intervention if duration will vary"/>
      <definition
                  value="An alternative textual narrative for the planned duration of trial intervention."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialParticipation"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="totalPlannedDurationOfTrialParticipation"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipation.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value=" C218715/C218716 total planned duration of trial participation value/units"/>
      <definition value="The total planned duration of trial participation"/>
      <type>
        <code value="time"/>
      </type>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime">
      <path value="Extension.extension"/>
      <sliceName value="totalPlannedDurationOfTrialParticipationUnitOfTime"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:totalPlannedDurationOfTrialParticipationUnitOfTime.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="totalPlannedDurationOfTrialParticipationUnitOfTime"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation">
      <path value="Extension.extension"/>
      <sliceName
                 value="alternateDescriptionOfPlannedDurationOfTrialParticipation"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.url">
      <path value="Extension.extension.url"/>
      <fixedUri
                value="alternateDescriptionOfPlannedDurationOfTrialParticipation"/>
    </element>
    <element
             id="Extension.extension:alternateDescriptionOfPlannedDurationOfTrialParticipation.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short
             value="C218717 alternate description of planned duration of trial participation if duration will vary"/>
      <definition
                  value="An alternative narrative for the planned duration of trial participation."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:additionalDescriptionofDuration">
      <path value="Extension.extension"/>
      <sliceName value="additionalDescriptionofDuration"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element
             id="Extension.extension:additionalDescriptionofDuration.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:additionalDescriptionofDuration.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="additionalDescriptionofDuration"/>
    </element>
    <element
             id="Extension.extension:additionalDescriptionofDuration.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218838 Additional Description of Duration"/>
      <definition
                  value="A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:independentCommittees">
      <path value="Extension.extension"/>
      <sliceName value="independentCommittees"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:independentCommittees.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:independentCommittees.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="independentCommittees"/>
    </element>
    <element id="Extension.extension:independentCommittees.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C217282 Independent Committees"/>
      <definition
                  value="An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities."/>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <binding>
        <strength value="required"/>
        <valueSet
                  value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-independentCommittees-vs"/>
      </binding>
    </element>
    <element id="Extension.extension:otherCommittees">
      <path value="Extension.extension"/>
      <sliceName value="otherCommittees"/>
      <min value="1"/>
      <max value="*"/>
    </element>
    <element id="Extension.extension:otherCommittees.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:otherCommittees.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="otherCommittees"/>
    </element>
    <element id="Extension.extension:otherCommittees.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218719 Other Committees"/>
      <definition
                  value="A committee that is different than the one(s) previously specified or mentioned."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:trialSchema">
      <path value="Extension.extension"/>
      <sliceName value="trialSchema"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:trialSchema.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:trialSchema.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="trialSchema"/>
    </element>
    <element id="Extension.extension:trialSchema.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C93682 Trial Schema"/>
      <definition
                  value="A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:schemaNotes">
      <path value="Extension.extension"/>
      <sliceName value="schemaNotes"/>
      <min value="1"/>
      <max value="1"/>
    </element>
    <element id="Extension.extension:schemaNotes.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:schemaNotes.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="schemaNotes"/>
    </element>
    <element id="Extension.extension:schemaNotes.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C218720 Schema Notes"/>
      <definition
                  value="A brief written record describing the trial schematic."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.extension:scheduleofActivities">
      <path value="Extension.extension"/>
      <sliceName value="scheduleofActivities"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Extension.extension:scheduleofActivities.extension">
      <path value="Extension.extension.extension"/>
      <max value="0"/>
    </element>
    <element id="Extension.extension:scheduleofActivities.url">
      <path value="Extension.extension.url"/>
      <fixedUri value="scheduleofActivities"/>
    </element>
    <element id="Extension.extension:scheduleofActivities.value[x]">
      <path value="Extension.extension.value[x]"/>
      <short value="C132349 Schedule of Activities"/>
      <definition
                  value="The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended."/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="Extension.url">
      <path value="Extension.url"/>
      <fixedUri
                value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"/>
    </element>
    <element id="Extension.value[x]">
      <path value="Extension.value[x]"/>
      <max value="0"/>
    </element>
  </differential>
</StructureDefinition>