Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: M11Report - Mappings

Page standards status: Draft Maturity Level: 1

Mappings for the m11-report resource profile.

Mappings for Workflow Pattern (http://hl7.org/fhir/workflow)

M11Report
CompositionEvent
   identifierEvent.identifier
   statusEvent.status
   typeEvent.code
   subjectEvent.subject
   encounterEvent.encounter
   dateEvent.occurrence[x]
   authorEvent.performer

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

M11Report
Compositioninfrastructure.documents
   urlFiveWs.identifier
   identifierFiveWs.identifier
   versionFiveWs.version
   statusFiveWs.status
   typeFiveWs.class
   categoryFiveWs.class
   subjectFiveWs.subject[x]
   encounterFiveWs.context
   dateFiveWs.done[x]
   authorFiveWs.author
   attester
      partyFiveWs.witness
   section
      authorFiveWs.author
      section
   section (titlepage)
      authorFiveWs.author
      section
      section (confidentiality)
         authorFiveWs.author
         section
      section (title)
         authorFiveWs.author
         section
      section (acronym)
         authorFiveWs.author
         section
      section (identifier)
         authorFiveWs.author
         section
      section (original)
         authorFiveWs.author
         section
      section (version)
         authorFiveWs.author
         section
      section (versiondate)
         authorFiveWs.author
         section
      section (amendmentidentifier)
         authorFiveWs.author
         section
      section (amendmentscope)
         authorFiveWs.author
         section
      section (compoundcode)
         authorFiveWs.author
         section
      section (compoundname)
         authorFiveWs.author
         section
      section (trialphase)
         authorFiveWs.author
         section
      section (shorttitle)
         authorFiveWs.author
         section
      section (sponsorname)
         authorFiveWs.author
         section
      section (manufacturer)
         authorFiveWs.author
         section
      section (regulatoryidentifiers)
         authorFiveWs.author
         section
      section (sponsorapproval)
         authorFiveWs.author
         section
      section (signatory)
         authorFiveWs.author
         section
      section (medicalexpert)
         authorFiveWs.author
         section
      section (saereporting)
         authorFiveWs.author
         section
      section (amendment)
         authorFiveWs.author
         section
   section (summary)
      authorFiveWs.author
      section
      section (protocolSynopsis)
         authorFiveWs.author
         section
         section (objectivesEndpoints)
            authorFiveWs.author
            section
         section (overallDesign)
            authorFiveWs.author
            section
         section (numberOfArms)
            authorFiveWs.author
            section
         section (blinding)
            authorFiveWs.author
            section
         section (numberOfParticipants)
            authorFiveWs.author
            section
         section (duration)
            authorFiveWs.author
            section
         section (committees)
            authorFiveWs.author
            section
      section (trialSchema)
         authorFiveWs.author
         section
      section (scheduleOfActivities)
         authorFiveWs.author
         section
   section (introduction)
      authorFiveWs.author
      section
      section (purposeOfTrial)
         authorFiveWs.author
         section
      section (benefitsAndRisks)
         authorFiveWs.author
         section
         section (benefitSummary)
            authorFiveWs.author
            section
         section (riskSummary)
            authorFiveWs.author
            section
            section (trialIntervention)
               authorFiveWs.author
            section (trialProcedures)
               authorFiveWs.author
            section (otherRisk)
               authorFiveWs.author
         section (overallBenefitRisk)
            authorFiveWs.author
            section
   section (endpoints)
      authorFiveWs.author
      section
      section (primaryEstimands)
         authorFiveWs.author
         section
         section (objectiveEstimand)
            authorFiveWs.author
            section
            section (population)
               authorFiveWs.author
            section (treatment)
               authorFiveWs.author
            section (endpoint)
               authorFiveWs.author
            section (estimand)
               authorFiveWs.author
            section (intercurrent)
               authorFiveWs.author
      section (secondaryEstimands)
         authorFiveWs.author
         section
         section (objectiveEstimand)
            authorFiveWs.author
            section
            section (population)
               authorFiveWs.author
            section (treatment)
               authorFiveWs.author
            section (endpoint)
               authorFiveWs.author
            section (estimand)
               authorFiveWs.author
            section (intercurrent)
               authorFiveWs.author
      section (exploratoryEstimands)
         authorFiveWs.author
         section
         section (objectiveEstimand)
            authorFiveWs.author
            section
            section (population)
               authorFiveWs.author
            section (treatment)
               authorFiveWs.author
            section (endpoint)
               authorFiveWs.author
            section (estimand)
               authorFiveWs.author
            section (intercurrent)
               authorFiveWs.author
   section (design)
      authorFiveWs.author
      section
      section (description)
         authorFiveWs.author
         section
         section (stakeholderInput)
            authorFiveWs.author
            section
      section (rationale)
         authorFiveWs.author
         section
         section (model)
            authorFiveWs.author
            section
         section (duration)
            authorFiveWs.author
            section
         section (endpoints)
            authorFiveWs.author
            section
         section (interim)
            authorFiveWs.author
            section
         section (comparator)
            authorFiveWs.author
            section
         section (adaptive)
            authorFiveWs.author
            section
         section (otherAspects)
            authorFiveWs.author
            section
      section (trialStoppingRules)
         authorFiveWs.author
         section
      section (startEnd)
         authorFiveWs.author
         section
      section (access)
         authorFiveWs.author
         section
   section (population)
      authorFiveWs.author
      section
      section (description)
         authorFiveWs.author
         section
      section (inclusionCriteria)
         authorFiveWs.author
         section
      section (exclusionCriteria)
         authorFiveWs.author
         section
      section (contraception)
         authorFiveWs.author
         section
         section (contraceptionDefinitions)
            authorFiveWs.author
            section
         section (contraceptionDetails)
            authorFiveWs.author
            section
      section (lifestyle)
         authorFiveWs.author
         section
         section (dietary)
            authorFiveWs.author
            section
         section (substances)
            authorFiveWs.author
            section
         section (activity)
            authorFiveWs.author
            section
         section (other)
            authorFiveWs.author
            section
      section (screenFailures)
         authorFiveWs.author
         section
   section (intervention)
      authorFiveWs.author
      section
      section (overview)
         authorFiveWs.author
         section
      section (description)
         authorFiveWs.author
         section
      section (rationale)
         authorFiveWs.author
         section
      section (dosingAdministration)
         authorFiveWs.author
         section
      section (doseModification)
         authorFiveWs.author
         section
      section (treatmentOfOverdose)
         authorFiveWs.author
         section
      section (preparation)
         authorFiveWs.author
         section
         section (preparationIntervention)
            authorFiveWs.author
            section
         section (storageHandling)
            authorFiveWs.author
            section
         section (accountability)
            authorFiveWs.author
            section
      section (assignmentAndBlinding)
         authorFiveWs.author
         section
         section (assignment)
            authorFiveWs.author
            section
         section (randomisation)
            authorFiveWs.author
            section
         section (blinding)
            authorFiveWs.author
            section
         section (unblinding)
            authorFiveWs.author
            section
      section (compliance)
         authorFiveWs.author
         section
      section (noninvestigationalTherapy)
         authorFiveWs.author
         section
         section (background)
            authorFiveWs.author
            section
         section (rescue)
            authorFiveWs.author
            section
         section (other)
            authorFiveWs.author
            section
      section (concomitantTherapy)
         authorFiveWs.author
         section
         section (prohibited)
            authorFiveWs.author
            section
         section (permitted)
            authorFiveWs.author
            section
   section (dropout)
      authorFiveWs.author
      section
      section (discontinuation)
         authorFiveWs.author
         section
         section (permanent)
            authorFiveWs.author
            section
         section (temporary)
            authorFiveWs.author
            section
         section (rechallenge)
            authorFiveWs.author
            section
      section (withdrawal)
         authorFiveWs.author
         section
      section (lostToFollowUp)
         authorFiveWs.author
         section
   section (assessments)
      authorFiveWs.author
      section
      section (considerations)
         authorFiveWs.author
         section
      section (screeningBaseline)
         authorFiveWs.author
         section
      section (efficacy)
         authorFiveWs.author
         section
      section (safety)
         authorFiveWs.author
         section
         section (physical)
            authorFiveWs.author
            section
         section (vitals)
            authorFiveWs.author
            section
         section (ecg)
            authorFiveWs.author
            section
         section (laboratory)
            authorFiveWs.author
            section
         section (pregnancy)
            authorFiveWs.author
            section
         section (suicidal)
            authorFiveWs.author
            section
      section (pharmacokinetics)
         authorFiveWs.author
         section
      section (biomarkers)
         authorFiveWs.author
         section
         section (genetics)
            authorFiveWs.author
            section
         section (pharmacodynamics)
            authorFiveWs.author
            section
         section (other)
            authorFiveWs.author
            section
      section (immunogenicity)
         authorFiveWs.author
         section
      section (economics)
         authorFiveWs.author
         section
   section (adverseEvents)
      authorFiveWs.author
      section
      section (definitions)
         authorFiveWs.author
         section
         section (adverseEventsDefinitions)
            authorFiveWs.author
            section
         section (seriousAdverseEventsDefinitions)
            authorFiveWs.author
            section
         section (productComplaintsDefinitions)
            authorFiveWs.author
            section
      section (collectionMethods)
         authorFiveWs.author
         section
      section (recording)
         authorFiveWs.author
         section
         section (identifying)
            authorFiveWs.author
            section
         section (intensity)
            authorFiveWs.author
            section
         section (causality)
            authorFiveWs.author
            section
         section (followup)
            authorFiveWs.author
            section
      section (reporting)
         authorFiveWs.author
         section
         section (regulatoryRequirements)
            authorFiveWs.author
            section
         section (specialInterest)
            authorFiveWs.author
            section
         section (diseaseRelatedEvents)
            authorFiveWs.author
            section
      section (pregnancy)
         authorFiveWs.author
         section
         section (pregnant)
            authorFiveWs.author
            section
         section (pregnantPartner)
            authorFiveWs.author
            section
   section (statistics)
      authorFiveWs.author
      section
      section (considerations)
         authorFiveWs.author
         section
      section (analysisSets)
         authorFiveWs.author
         section
      section (analysisBaseline)
         authorFiveWs.author
         section
      section (analysisPrimaryObjective)
         authorFiveWs.author
         section
         section (analysisPrimaryInstance)
            authorFiveWs.author
            section
            section (statisticalModel)
               authorFiveWs.author
            section (intercurrentEventHandling)
               authorFiveWs.author
            section (missingData)
               authorFiveWs.author
            section (sensitvityAnalysis)
               authorFiveWs.author
            section (supplementaryAnalysis)
               authorFiveWs.author
      section (secondaryAnalysis)
         authorFiveWs.author
         section
         section (analysisSecondaryInstance)
            authorFiveWs.author
            section
            section (statisticalModel)
               authorFiveWs.author
            section (intercurrentEventHandling)
               authorFiveWs.author
            section (missingData)
               authorFiveWs.author
            section (sensitvityAnalysis)
               authorFiveWs.author
            section (supplementaryAnalysis)
               authorFiveWs.author
      section (exploratoryAnalysis)
         authorFiveWs.author
         section
      section (safetyAnalyses)
         authorFiveWs.author
         section
      section (otherAnalyses)
         authorFiveWs.author
         section
      section (multiplicity)
         authorFiveWs.author
         section
      section (interimAnalyses)
         authorFiveWs.author
         section
      section (sampleSize)
         authorFiveWs.author
         section
   section (oversight)
      authorFiveWs.author
      section
      section (regulatory)
         authorFiveWs.author
         section
      section (trialOversight)
         authorFiveWs.author
         section
         section (investigatorResponsibilities)
            authorFiveWs.author
         section (sponsorResponsibilities)
            authorFiveWs.author
      section (committees)
         authorFiveWs.author
         section
      section (informedConsent)
         authorFiveWs.author
         section
         section (assentProcess)
            authorFiveWs.author
         section (emergency)
            authorFiveWs.author
         section (rescreening)
            authorFiveWs.author
         section (remainingSamples)
            authorFiveWs.author
      section (insurance)
         authorFiveWs.author
         section
      section (riskManagement)
         authorFiveWs.author
         section
      section (dataGovernance)
         authorFiveWs.author
         section
      section (sourceData)
         authorFiveWs.author
         section
      section (protcolDeviations)
         authorFiveWs.author
         section
      section (earlySiteClosure)
         authorFiveWs.author
         section
         section (decisionRights)
            authorFiveWs.author
         section (criteria)
            authorFiveWs.author
         section (responsibilities)
            authorFiveWs.author
   section (definitions)
      authorFiveWs.author
      section
      section (clinicalLaboratoryTests)
         authorFiveWs.author
      section (regional)
         authorFiveWs.author
      section (priorAmendments)
         authorFiveWs.author
   section (glossary)
      authorFiveWs.author
   section (references)
      authorFiveWs.author

Mappings for RIM Mapping (http://hl7.org/v3)

M11Report
CompositionEntity, Role, or Act,Document[classCode="DOC" and moodCode="EVN" and isNormalAct()]
   textAct.text?
   containedN/A
   modifierExtensionN/A
   identifierDocument.id / Document.setId
   statusinterim: .completionCode="IN" & ./statusCode[isNormalDatatype()]="active"; final: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and not(./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct()]); amended: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and ./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct() and statusCode="completed"]; withdrawn : .completionCode=NI && ./statusCode[isNormalDatatype()]="obsolete"
   type./code
      idn/a
      extensionn/a
      codingunion(., ./translation)
      text./originalText[mediaType/code="text/plain"]/data
   category.outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
   subject.participation[typeCode="SBJ"].role[typeCode="PAT"]
   encounterunique(highest(./outboundRelationship[typeCode="SUBJ" and isNormalActRelationship()], priorityNumber)/target[moodCode="EVN" and classCode=("ENC", "PCPR") and isNormalAct])
   date.effectiveTime[type="TS"]
   author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
   title./title
   attester.participation[typeCode="AUTHEN"].role[classCode="ASSIGNED"]
      idn/a
      extensionn/a
      modifierExtensionN/A
      modeunique(./modeCode)
      time./time[type="TS" and isNormalDatatype()]
      party./role[classCode="ASSIGNED" and isNormalRole]/player[determinerCode="INST" and classCode=("DEV", "PSN") and isNormalEntity()] or ./role[classCode="ASSIGNED" and isNormalRole and not(player)]/scoper[determinerCode="INST" and classCode="ORG" and isNormalEntity()]
   custodian.participation[typeCode="RCV"].role[classCode="CUST"].scoper[classCode="ORG" and determinerCode="INST"]
   relatesTo.outboundRelationship
   eventoutboundRelationship[typeCode="SUBJ"].target[classCode<'ACT']
      idn/a
      extensionn/a
      modifierExtensionN/A
      period.effectiveTime
      detail.outboundRelationship[typeCode="SUBJ"].target
   section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (titlepage)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (confidentiality)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (title)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (acronym)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (identifier)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (original)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (version)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (versiondate)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (amendmentidentifier)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (amendmentscope)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (compoundcode)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (compoundname)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (trialphase)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (shorttitle)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (sponsorname)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (manufacturer)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (regulatoryidentifiers)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (sponsorapproval)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (signatory)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (medicalexpert)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (saereporting)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (amendment)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (summary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (protocolSynopsis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (objectivesEndpoints)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (overallDesign)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (numberOfArms)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (blinding)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (numberOfParticipants)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (duration)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (committees)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (trialSchema)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (scheduleOfActivities)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (introduction)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (purposeOfTrial)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (benefitsAndRisks)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (benefitSummary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (riskSummary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (trialIntervention)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (trialProcedures)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (otherRisk)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (overallBenefitRisk)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (endpoints)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (primaryEstimands)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (objectiveEstimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (population)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (treatment)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (endpoint)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (estimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (intercurrent)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (secondaryEstimands)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (objectiveEstimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (population)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (treatment)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (endpoint)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (estimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (intercurrent)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (exploratoryEstimands)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (objectiveEstimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (population)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (treatment)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (endpoint)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (estimand)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (intercurrent)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (design)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (description)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (stakeholderInput)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (rationale)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (model)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (duration)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (endpoints)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (interim)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (comparator)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (adaptive)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (otherAspects)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (trialStoppingRules)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (startEnd)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (access)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (population)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (description)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (inclusionCriteria)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (exclusionCriteria)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (contraception)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (contraceptionDefinitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (contraceptionDetails)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (lifestyle)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (dietary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (substances)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (activity)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (other)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (screenFailures)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (intervention)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (overview)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (description)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (rationale)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (dosingAdministration)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (doseModification)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (treatmentOfOverdose)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (preparation)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (preparationIntervention)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (storageHandling)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (accountability)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (assignmentAndBlinding)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (assignment)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (randomisation)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (blinding)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (unblinding)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (compliance)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (noninvestigationalTherapy)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (background)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (rescue)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (other)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (concomitantTherapy)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (prohibited)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (permitted)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (dropout)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (discontinuation)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (permanent)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (temporary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (rechallenge)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (withdrawal)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (lostToFollowUp)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (assessments)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (considerations)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (screeningBaseline)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (efficacy)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (safety)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (physical)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (vitals)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (ecg)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (laboratory)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (pregnancy)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (suicidal)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (pharmacokinetics)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (biomarkers)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (genetics)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (pharmacodynamics)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (other)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (immunogenicity)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (economics)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (adverseEvents)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (definitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (adverseEventsDefinitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (seriousAdverseEventsDefinitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (productComplaintsDefinitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (collectionMethods)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (recording)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (identifying)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (intensity)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (causality)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (followup)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (reporting)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (regulatoryRequirements)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (specialInterest)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (diseaseRelatedEvents)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (pregnancy)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (pregnant)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (pregnantPartner)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (statistics)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (considerations)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (analysisSets)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (analysisBaseline)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (analysisPrimaryObjective)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (analysisPrimaryInstance)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (statisticalModel)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (intercurrentEventHandling)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (missingData)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (sensitvityAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (supplementaryAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (secondaryAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (analysisSecondaryInstance)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (statisticalModel)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (intercurrentEventHandling)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (missingData)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (sensitvityAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            section (supplementaryAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
               idn/a
               extensionn/a
               modifierExtensionN/A
               title./title
               code./code
                  idn/a
                  extensionn/a
                  codingunion(., ./translation)
                  text./originalText[mediaType/code="text/plain"]/data
               author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
               text.text
               orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
               entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
               emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
               section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (exploratoryAnalysis)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (safetyAnalyses)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (otherAnalyses)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (multiplicity)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (interimAnalyses)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (sampleSize)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (oversight)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (regulatory)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (trialOversight)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (investigatorResponsibilities)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (sponsorResponsibilities)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (committees)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (informedConsent)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (assentProcess)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (emergency)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (rescreening)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (remainingSamples)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (insurance)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (riskManagement)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (dataGovernance)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (sourceData)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (protcolDeviations)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (earlySiteClosure)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (decisionRights)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (criteria)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         section (responsibilities)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
            idn/a
            extensionn/a
            modifierExtensionN/A
            title./title
            code./code
               idn/a
               extensionn/a
               codingunion(., ./translation)
               text./originalText[mediaType/code="text/plain"]/data
            author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
            text.text
            orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
            entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
            emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
            section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (definitions)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (clinicalLaboratoryTests)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (regional)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      section (priorAmendments)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
         idn/a
         extensionn/a
         modifierExtensionN/A
         title./title
         code./code
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
         text.text
         orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
         entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
         emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
         section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (glossary)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
   section (references)./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
      idn/a
      extensionn/a
      modifierExtensionN/A
      title./title
      code./code
         idn/a
         extensionn/a
         codingunion(., ./translation)
         text./originalText[mediaType/code="text/plain"]/data
      author.participation[typeCode="AUT"].role[classCode="ASSIGNED"]
      text.text
      orderedBy.outboundRelationship[typeCode=COMP].sequenceNumber > 1
      entry.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
      emptyReason.inboundRelationship[typeCode=SUBJ,code<ListEmptyReason].value[type=CD]
      section./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]

Mappings for CDA (R2) (http://hl7.org/v3/cda)

M11Report
CompositionClinicalDocument
   identifier.setId
   version.versionNumber
   statusn/a
   type.code
   categoryn/a
   subject.recordTarget
   encounter.componentOf.encompassingEncounter
   date.effectiveTime
   author.author.assignedAuthor
   title.title
   attester.authenticator/.legalAuthenticator
      modeimplied by .authenticator/.legalAuthenticator
      time.authenticator.time
      party.authenticator.assignedEnttty
   custodian.custodian.assignedCustodian
   relatesTo.relatedDocument
   event.documentationOf.serviceEvent
      period.effectiveTime
      detailn/a
   section.component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
   section (titlepage).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (confidentiality).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (title).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (acronym).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (identifier).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (original).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (version).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (versiondate).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (amendmentidentifier).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (amendmentscope).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (compoundcode).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (compoundname).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (trialphase).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (shorttitle).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (sponsorname).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (manufacturer).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (regulatoryidentifiers).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (sponsorapproval).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (signatory).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (medicalexpert).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (saereporting).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (amendment).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (summary).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (protocolSynopsis).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (objectivesEndpoints).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (overallDesign).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (numberOfArms).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (blinding).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (numberOfParticipants).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (duration).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (committees).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (trialSchema).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (scheduleOfActivities).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (introduction).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (purposeOfTrial).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (benefitsAndRisks).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (benefitSummary).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (riskSummary).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (trialIntervention).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (trialProcedures).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (otherRisk).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
         section (overallBenefitRisk).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
   section (endpoints).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (primaryEstimands).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (objectiveEstimand).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (population).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (treatment).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (endpoint).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (estimand).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (intercurrent).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
      section (secondaryEstimands).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (objectiveEstimand).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (population).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (treatment).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (endpoint).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (estimand).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (intercurrent).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
      section (exploratoryEstimands).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (objectiveEstimand).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (population).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (treatment).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (endpoint).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (estimand).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (intercurrent).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
   section (design).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (description).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (stakeholderInput).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (rationale).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (model).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (duration).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (endpoints).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (interim).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (comparator).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (adaptive).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (otherAspects).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (trialStoppingRules).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (startEnd).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (access).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (population).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (description).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (inclusionCriteria).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (exclusionCriteria).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (contraception).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (contraceptionDefinitions).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (contraceptionDetails).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (lifestyle).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (dietary).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (substances).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (activity).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (other).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (screenFailures).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (intervention).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (overview).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (description).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (rationale).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (dosingAdministration).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (doseModification).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (treatmentOfOverdose).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (preparation).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (preparationIntervention).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (storageHandling).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (accountability).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (assignmentAndBlinding).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (assignment).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (randomisation).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (blinding).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (unblinding).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (compliance).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (noninvestigationalTherapy).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (background).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (rescue).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (other).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (concomitantTherapy).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (prohibited).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (permitted).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
   section (dropout).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (discontinuation).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (permanent).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (temporary).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (rechallenge).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (withdrawal).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (lostToFollowUp).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (assessments).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (considerations).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (screeningBaseline).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (efficacy).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (safety).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (physical).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (vitals).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (ecg).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (laboratory).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (pregnancy).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (suicidal).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (pharmacokinetics).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (biomarkers).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (genetics).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (pharmacodynamics).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (other).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (immunogenicity).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (economics).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (adverseEvents).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (definitions).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (adverseEventsDefinitions).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (seriousAdverseEventsDefinitions).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (productComplaintsDefinitions).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (collectionMethods).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (recording).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (identifying).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (intensity).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (causality).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (followup).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (reporting).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (regulatoryRequirements).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (specialInterest).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (diseaseRelatedEvents).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (pregnancy).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (pregnant).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (pregnantPartner).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
   section (statistics).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (considerations).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (analysisSets).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (analysisBaseline).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (analysisPrimaryObjective).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (analysisPrimaryInstance).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (statisticalModel).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (intercurrentEventHandling).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (missingData).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (sensitvityAnalysis).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (supplementaryAnalysis).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
      section (secondaryAnalysis).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (analysisSecondaryInstance).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
            section (statisticalModel).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (intercurrentEventHandling).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (missingData).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (sensitvityAnalysis).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
            section (supplementaryAnalysis).component.section
               title.title
               code.code
               author.author.assignedAuthor
               focus.subject? (CDA did not differentiate between subject and focus)
               text.text
               orderedByn/a
               entry.entry
               emptyReasonn/a
               section.component.section
      section (exploratoryAnalysis).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (safetyAnalyses).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (otherAnalyses).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (multiplicity).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (interimAnalyses).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (sampleSize).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (oversight).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (regulatory).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (trialOversight).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (investigatorResponsibilities).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (sponsorResponsibilities).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (committees).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (informedConsent).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (assentProcess).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (emergency).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (rescreening).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (remainingSamples).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
      section (insurance).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (riskManagement).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (dataGovernance).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (sourceData).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (protcolDeviations).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (earlySiteClosure).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
         section (decisionRights).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (criteria).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
         section (responsibilities).component.section
            title.title
            code.code
            author.author.assignedAuthor
            focus.subject? (CDA did not differentiate between subject and focus)
            text.text
            orderedByn/a
            entry.entry
            emptyReasonn/a
            section.component.section
   section (definitions).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
      section (clinicalLaboratoryTests).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (regional).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
      section (priorAmendments).component.section
         title.title
         code.code
         author.author.assignedAuthor
         focus.subject? (CDA did not differentiate between subject and focus)
         text.text
         orderedByn/a
         entry.entry
         emptyReasonn/a
         section.component.section
   section (glossary).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section
   section (references).component.structuredBody.component.section
      title.title
      code.code
      author.author.assignedAuthor
      focus.subject? (CDA did not differentiate between subject and focus)
      text.text
      orderedByn/a
      entry.entry
      emptyReasonn/a
      section.component.section

Mappings for FHIR DocumentReference (http://hl7.org/fhir/documentreference)

M11Report
Compositionwhen described by DocumentReference
   identifierDocumentReference.identifier
   versionDocumentReference.version
   statusDocumentReference.docStatus
   typeDocumentReference.type
   categoryDocumenttReference.category
   subjectDocumentReference.subject
   encounterDocumentReference.context
   dateDocumentReference.content.attachment.date, DocumentReference.date
   authorDocumentReference.author
   titleDocumentReference.description, DocumentReference.content.attachment.title
   attesterDocumentReference.attester
      modeDocumentReference.attester.mode
      timeDocumentReference.attester.time
      partyDocumentReference.attester.party
   custodianDocumentReference.custodian
   relatesToDocumentReference.relatesTo
   event
      periodDocumentReference.period
      detailDocumentReference.event