Evidence Based Medicine on FHIR Implementation Guide
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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-ballot2 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

: Outcome Measures Report for NCT03640312 - JSON Representation

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          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
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            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
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        {
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
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                }
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            {
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
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                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
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            {
              "title" : "Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)",
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                "identifier" : {
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                  },
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                  "value" : "NCT03640312-secondaryOutcome-2",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-2--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  "display" : "Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312"
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                {
                  🔗 "reference" : "Evidence/367910",
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                  "identifier" : {
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-2--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  "display" : "Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312"
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                  🔗 "reference" : "Evidence/367944",
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                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
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                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
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    },
    {
      "title" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks",
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        "identifier" : {
          "type" : {
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          "value" : "NCT03640312-secondaryOutcome-3",
          "assigner" : {
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        "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)"
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          }
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        {
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                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
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                }
              ]
            },
            {
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                "text" : "OG001"
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
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                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
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          "section" : [
            {
              "title" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks at  (NCT03640312)",
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                    "system" : "https://fevir.net/resources/CodeSystem/179423",
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                🔗 "reference" : "EvidenceVariable/370506",
                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-3-6-weeks-",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks at  (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367911",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-3-6-weeks-OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367912",
                  "type" : "Evidence",
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                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-3-6-weeks-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for Candesartan in NCT03640312"
                }
              ]
            },
            {
              "title" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks at  (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
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                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
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                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-3-12-weeks-",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks at  (NCT03640312)"
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                  "identifier" : {
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-3-12-weeks-OG000",
                    "assigner" : {
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                  },
                  "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for QUARTET LDQT in NCT03640312"
                },
                {
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                    "assigner" : {
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                  },
                  "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for Candesartan in NCT03640312"
                }
              ]
            }
          ]
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        {
          "title" : "Outcome Analysis List for Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)",
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              "value" : "NCT03640312-secondaryOutcome-3",
              "assigner" : {
                "display" : "Computable Publishing LLC"
              }
            },
            "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)"
          },
          "entry" : [
            {
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              "identifier" : {
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                "system" : "https://fevir.net/FLI",
                "value" : "NCT03640312-secondaryOutcomeMeasure-3-OutcomeAnalysis-4-BetweenGroupAnalysis-OG000-OG001",
                "assigner" : {
                  "display" : "Computable Publishing LLC"
                }
              },
              "display" : "Proportion of Patients With Hypertension Control at 6 and 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
            }
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        }
      ]
    },
    {
      "title" : "Number of Patients Requiring Step up Treatment at 6 weeks",
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        🔗 "reference" : "EvidenceVariable/367887",
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          "type" : {
            "text" : "FEvIR Linking Identifier"
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          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-secondaryOutcome-4",
          "assigner" : {
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        },
        "display" : "Number of Patients Requiring Step up Treatment at 6 weeks (NCT03640312)"
      },
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            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
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        {
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            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
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                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
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                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
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                "text" : "OG001"
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
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              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
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            {
              "title" : "Number of Patients Requiring Step up Treatment at 6 weeks (NCT03640312)",
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                    "system" : "https://fevir.net/resources/CodeSystem/179423",
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                  "value" : "NCT03640312-secondaryOutcome-4",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Number of Patients Requiring Step up Treatment at 6 weeks (NCT03640312)"
              },
              "entry" : [
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                  🔗 "reference" : "Evidence/367915",
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                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-4--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Number of Patients Requiring Step up Treatment at 6 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367916",
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                  "identifier" : {
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                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-4--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Number of Patients Requiring Step up Treatment at 6 weeks for Candesartan in NCT03640312"
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                {
                  🔗 "reference" : "Evidence/367946",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-4-OutcomeAnalysis-5-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Number of Patients Requiring Step up Treatment at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
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        }
      ]
    },
    {
      "title" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367888",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
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          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-secondaryOutcome-5",
          "assigner" : {
            "display" : "Computable Publishing LLC"
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        },
        "display" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
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            "text" : "OutcomeMeasurePopulationDescription"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
        },
        {
          "title" : "Outcome Measure Reporting Status",
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            "text" : "OutcomeMeasureReportingStatus"
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            "status" : "generated",
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          }
        },
        {
          "title" : "Outcome Measure Time Frame",
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            "text" : "OutcomeMeasureTimeFrame"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
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        {
          "title" : "Outcome Group List",
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          "section" : [
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              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
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              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
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          "section" : [
            {
              "title" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
                    "code" : "results",
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              },
              "focus" : {
                🔗 "reference" : "EvidenceVariable/367888",
                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-5",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367917",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-5--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367918",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-5--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for Candesartan in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367947",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-5-OutcomeAnalysis-6-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title" : "Medication Adherence at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367889",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
          },
          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-secondaryOutcome-6",
          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Medication Adherence at 12 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
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            "text" : "OutcomeMeasurePopulationDescription"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
        },
        {
          "title" : "Outcome Measure Reporting Status",
          "code" : {
            "text" : "OutcomeMeasureReportingStatus"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title" : "Outcome Measure Time Frame",
          "code" : {
            "text" : "OutcomeMeasureTimeFrame"
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          "text" : {
            "status" : "generated",
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          }
        },
        {
          "title" : "Outcome Group List",
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            "text" : "OutcomeGroupList"
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          "section" : [
            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Medication Adherence at 12 weeks (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
                    "code" : "results",
                    "display" : "Results"
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                ]
              },
              "focus" : {
                🔗 "reference" : "EvidenceVariable/367889",
                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-6",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Medication Adherence at 12 weeks (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367919",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-6--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Medication Adherence at 12 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367920",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-6--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Medication Adherence at 12 weeks for Candesartan in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367948",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-6-OutcomeAnalysis-7-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Medication Adherence at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title" : "Health-related Quality of Life at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367890",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
          },
          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-secondaryOutcome-7",
          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Health-related Quality of Life at 12 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
          "code" : {
            "text" : "OutcomeMeasurePopulationDescription"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Data are available on only 28 participants in the intervention group for the mental health T score.</div>"
          }
        },
        {
          "title" : "Outcome Measure Reporting Status",
          "code" : {
            "text" : "OutcomeMeasureReportingStatus"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title" : "Outcome Measure Time Frame",
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
          }
        },
        {
          "title" : "Outcome Group List",
          "code" : {
            "text" : "OutcomeGroupList"
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          "section" : [
            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) at  (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
                    "code" : "results",
                    "display" : "Results"
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                ]
              },
              "focus" : {
                🔗 "reference" : "EvidenceVariable/370508",
                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-7-Change-in-Physical-Health-T-score--OPEN---PROMIS---CLOSE--",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) at  (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367921",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-7-Change-in-Physical-Health-T-score--OPEN---PROMIS---CLOSE--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367922",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-7-Change-in-Physical-Health-T-score--OPEN---PROMIS---CLOSE--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for Candesartan in NCT03640312"
                }
              ]
            },
            {
              "title" : "Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) at  (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
                    "code" : "results",
                    "display" : "Results"
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              },
              "focus" : {
                🔗 "reference" : "EvidenceVariable/370509",
                "type" : "EvidenceVariable",
                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) at  (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367923",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367924",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-7-Change-in-Mental-Health-T-score--OPEN---PROMIS---CLOSE--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312"
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Analysis List for Health-related Quality of Life at 12 weeks (NCT03640312)",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
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          "focus" : {
            🔗 "reference" : "EvidenceVariable/367890",
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            "identifier" : {
              "type" : {
                "text" : "FEvIR Linking Identifier"
              },
              "system" : "https://fevir.net/FLI",
              "value" : "NCT03640312-secondaryOutcome-7",
              "assigner" : {
                "display" : "Computable Publishing LLC"
              }
            },
            "display" : "Health-related Quality of Life at 12 weeks (NCT03640312)"
          },
          "entry" : [
            {
              🔗 "reference" : "Evidence/367949",
              "type" : "Evidence",
              "identifier" : {
                "type" : {
                  "text" : "FEvIR Linking Identifier"
                },
                "system" : "https://fevir.net/FLI",
                "value" : "NCT03640312-secondaryOutcomeMeasure-7-OutcomeAnalysis-8-BetweenGroupAnalysis-OG000-OG001",
                "assigner" : {
                  "display" : "Computable Publishing LLC"
                }
              },
              "display" : "Health-related Quality of Life at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
            },
            {
              🔗 "reference" : "Evidence/367950",
              "type" : "Evidence",
              "identifier" : {
                "type" : {
                  "text" : "FEvIR Linking Identifier"
                },
                "system" : "https://fevir.net/FLI",
                "value" : "NCT03640312-secondaryOutcomeMeasure-7-OutcomeAnalysis-9-BetweenGroupAnalysis-OG000-OG001",
                "assigner" : {
                  "display" : "Computable Publishing LLC"
                }
              },
              "display" : "Health-related Quality of Life at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
            }
          ]
        }
      ]
    },
    {
      "title" : "Change in Mean Systolic Blood Pressure at 6 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367891",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
          },
          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-secondaryOutcome-8",
          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Change in Mean Systolic Blood Pressure at 6 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
          "code" : {
            "text" : "OutcomeMeasurePopulationDescription"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
        },
        {
          "title" : "Outcome Measure Reporting Status",
          "code" : {
            "text" : "OutcomeMeasureReportingStatus"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title" : "Outcome Measure Time Frame",
          "code" : {
            "text" : "OutcomeMeasureTimeFrame"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">6 weeks</div>"
          }
        },
        {
          "title" : "Outcome Group List",
          "code" : {
            "text" : "OutcomeGroupList"
          },
          "section" : [
            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Change in Mean Systolic Blood Pressure at 6 weeks (NCT03640312)",
              "code" : {
                "coding" : [
                  {
                    "system" : "https://fevir.net/resources/CodeSystem/179423",
                    "code" : "results",
                    "display" : "Results"
                  }
                ]
              },
              "focus" : {
                🔗 "reference" : "EvidenceVariable/367891",
                "type" : "EvidenceVariable",
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                    "text" : "FEvIR Linking Identifier"
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                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-secondaryOutcome-8",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Change in Mean Systolic Blood Pressure at 6 weeks (NCT03640312)"
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              "entry" : [
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                  🔗 "reference" : "Evidence/367925",
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                  "identifier" : {
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                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-8--OG000",
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                  "display" : "Change in Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312"
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                  🔗 "reference" : "Evidence/367926",
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                  "identifier" : {
                    "type" : {
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-secondaryOutcomeMeasure-8--OG001",
                    "assigner" : {
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                  },
                  "display" : "Change in Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312"
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                  🔗 "reference" : "Evidence/367951",
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                    "value" : "NCT03640312-secondaryOutcomeMeasure-8-OutcomeAnalysis-10-BetweenGroupAnalysis-OG000-OG001",
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                  "display" : "Change in Mean Systolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
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        }
      ]
    },
    {
      "title" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367896",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
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          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-otherOutcome-0",
          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)"
      },
      "section" : [
        {
          "title" : "Outcome Measure Population Description",
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            "text" : "OutcomeMeasurePopulationDescription"
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            "status" : "generated",
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            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
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          "section" : [
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                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
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              "text" : {
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                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
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            {
              "title" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)",
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                  "value" : "NCT03640312-otherOutcome-0",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367927",
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                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-0--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  "display" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312"
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                  🔗 "reference" : "Evidence/367928",
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                    "type" : {
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-0--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for Candesartan in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367952",
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                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-0-OutcomeAnalysis-11-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks",
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        🔗 "reference" : "EvidenceVariable/367897",
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        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
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          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-otherOutcome-1",
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        "display" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks (NCT03640312)"
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            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants</div>"
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              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
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                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks (NCT03640312)",
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                "identifier" : {
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                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-otherOutcome-1",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367929",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-1--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367930",
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                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
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                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-1--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks for Candesartan in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367953",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-1-OutcomeAnalysis-12-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
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                  },
                  "display" : "Percentage of Participants With Potentially Related Adverse Events at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
            }
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        }
      ]
    },
    {
      "title" : "Rate of Adverse Events of Special Interest at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367898",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
          },
          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-otherOutcome-2",
          "assigner" : {
            "display" : "Computable Publishing LLC"
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        "display" : "Rate of Adverse Events of Special Interest at 12 weeks (NCT03640312)"
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      "section" : [
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            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
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        {
          "title" : "Outcome Group List",
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            "text" : "OutcomeGroupList"
          },
          "section" : [
            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Rate of Adverse Events of Special Interest at 12 weeks (NCT03640312)",
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                "identifier" : {
                  "type" : {
                    "text" : "FEvIR Linking Identifier"
                  },
                  "system" : "https://fevir.net/FLI",
                  "value" : "NCT03640312-otherOutcome-2",
                  "assigner" : {
                    "display" : "Computable Publishing LLC"
                  }
                },
                "display" : "Rate of Adverse Events of Special Interest at 12 weeks (NCT03640312)"
              },
              "entry" : [
                {
                  🔗 "reference" : "Evidence/367931",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-2--OG000",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367932",
                  "type" : "Evidence",
                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-2--OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Rate of Adverse Events of Special Interest at 12 weeks for Candesartan in NCT03640312"
                },
                {
                  🔗 "reference" : "Evidence/367954",
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                  "identifier" : {
                    "type" : {
                      "text" : "FEvIR Linking Identifier"
                    },
                    "system" : "https://fevir.net/FLI",
                    "value" : "NCT03640312-otherOutcomeMeasure-2-OutcomeAnalysis-13-BetweenGroupAnalysis-OG000-OG001",
                    "assigner" : {
                      "display" : "Computable Publishing LLC"
                    }
                  },
                  "display" : "Rate of Adverse Events of Special Interest at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "title" : "Mean Change in Serum Potassium at 12 weeks",
      "focus" : {
        🔗 "reference" : "EvidenceVariable/367899",
        "type" : "EvidenceVariable",
        "identifier" : {
          "type" : {
            "text" : "FEvIR Linking Identifier"
          },
          "system" : "https://fevir.net/FLI",
          "value" : "NCT03640312-otherOutcome-3",
          "assigner" : {
            "display" : "Computable Publishing LLC"
          }
        },
        "display" : "Mean Change in Serum Potassium at 12 weeks (NCT03640312)"
      },
      "section" : [
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          "title" : "Outcome Measure Population Description",
          "code" : {
            "text" : "OutcomeMeasurePopulationDescription"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</div>"
          }
        },
        {
          "title" : "Outcome Measure Reporting Status",
          "code" : {
            "text" : "OutcomeMeasureReportingStatus"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"
          }
        },
        {
          "title" : "Outcome Measure Time Frame",
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            "text" : "OutcomeMeasureTimeFrame"
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          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
          }
        },
        {
          "title" : "Outcome Group List",
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            "text" : "OutcomeGroupList"
          },
          "section" : [
            {
              "title" : "QUARTET LDQT",
              "code" : {
                "text" : "OG000"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
                }
              ]
            },
            {
              "title" : "Candesartan",
              "code" : {
                "text" : "OG001"
              },
              "text" : {
                "status" : "generated",
                "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
              },
              "entry" : [
                {
                  "display" : "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
                }
              ]
            }
          ]
        },
        {
          "title" : "Outcome Class List",
          "code" : {
            "text" : "OutcomeClassList"
          },
          "section" : [
            {
              "title" : "Mean Change in Serum Potassium at 12 weeks (NCT03640312)",
              "code" : {
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                  "display" : "Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
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      "title" : "Mean Change in Serum Creatinine at 12 weeks",
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          "type" : {
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                "display" : "Mean Change in Serum Creatinine at 12 weeks (NCT03640312)"
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                  "display" : "Mean Change in Serum Creatinine at 12 weeks for Candesartan in NCT03640312"
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                  },
                  "display" : "Mean Change in Serum Creatinine at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"
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}