Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-03-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-04-21"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2023-03-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Participants for whom Narcotics were used for pain during surgery"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "value": "Post Anesthesia Care Unit (PACU) Narcotic Use"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "value": "Participants for whom Narcotics were used in PACU"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
    "value": "Postoperative Narcotic Use"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
    "value": "Participants for whom Narcotics were used postoperatively"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Pain Control Measured by Length of Operation"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Pain Control Measured by Estimated Blood Loss"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Participants With Postoperative Nausea"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "count of participants who reported nausea after surgery"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "Pain Control Measured by Pain Scale"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "value": "Pain measured on scale of one to ten, one being least amount of pain and ten the greatest."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "Pain Control Measured by the Use of Pain Pills Postoperatively"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Participants who used narcotic pain pills postoperatively"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "value": "Pain Control Measured by Calls to Physicians Office Relating to Pain"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "value": "Number of phone calls made to physician office regarding pain"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
    "value": "Esther L Peariso"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "marianne.melnik@corewellhealth.org",
          "phone": "616-486-6333",
          "title": "Marianne Melnik",
          "organization": "Spectrum Health"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        },
        "limitationsAndCaveats": {
          "description": "Study was terminated early due to clinical practice outpacing the science of the trial.\nAt the time of stopping enrollment, pectoral nerve blocks were being used standardly.\nTherefore, we could not ethically continue to randomize patients to both arms."
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Adverse events were collected from the time of surgery until the 2 week post op appointment",
        "description": "pain was not considered an adverse event unless it reached a grade 3 by CTCAE v4.0",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Paravertebral Block",
            "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>",
            "otherNumAtRisk": 40,
            "deathsNumAtRisk": 40,
            "otherNumAffected": 0,
            "seriousNumAtRisk": 40,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          },
          {
            "id": "EG001",
            "title": "Pectoral Nerve Block",
            "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>",
            "otherNumAtRisk": 49,
            "deathsNumAtRisk": 49,
            "otherNumAffected": 0,
            "seriousNumAtRisk": 49,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Intraoperative Narcotic Use",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "26",
                        "groupId": "OG000"
                      },
                      {
                        "value": "29",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "First 24 hours post-PACU (or until discharge)",
            "reviewUnit": {
              "resetReasons": [
                "The Time Frame appears inconsistent with information provided here or in other parts of the record."
              ]
            },
            "description": "Participants for whom Narcotics were used for pain during surgery",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "PRIMARY",
            "title": "Post Anesthesia Care Unit (PACU) Narcotic Use",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "20",
                        "groupId": "OG000"
                      },
                      {
                        "value": "33",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "First 24 hours post-PACU (or until discharge)",
            "reviewUnit": {
              "resetReasons": [
                "The Time Frame appears inconsistent with information provided here or in other parts of the record."
              ]
            },
            "description": "Participants for whom Narcotics were used in PACU",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "PRIMARY",
            "title": "Postoperative Narcotic Use",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      },
                      {
                        "value": "1",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "First 24 hours post-PACU (or until discharge)",
            "description": "Participants for whom Narcotics were used postoperatively",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Pain Control Measured by Length of Operation",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "61.80",
                        "spread": "16.42",
                        "groupId": "OG000"
                      },
                      {
                        "value": "64.14",
                        "spread": "20.20",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "timeFrame": "2 weeks postoperative",
            "reviewUnit": {
              "resetReasons": [
                "The Time Frame appears inconsistent with information provided here or in other parts of the record."
              ]
            },
            "description": "Measuring pain control by how long (in minutes) patient is in surgery",
            "unitOfMeasure": "minutes",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Pain Control Measured by Estimated Blood Loss",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "10.85",
                        "spread": "8.3",
                        "groupId": "OG000"
                      },
                      {
                        "value": "13.8",
                        "spread": "12.29",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "timeFrame": "2 weeks postoperative",
            "reviewUnit": {
              "resetReasons": [
                "The Time Frame appears inconsistent with information provided here or in other parts of the record."
              ]
            },
            "description": "Measuring blood loss (in ml) during surgery",
            "unitOfMeasure": "milliliters",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Participants With Postoperative Nausea",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "39",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "OG000"
                      },
                      {
                        "value": "1",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "2 weeks postoperative",
            "description": "count of participants who reported nausea after surgery",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Paravertebral population had one non-reporting participant"
          },
          {
            "type": "SECONDARY",
            "title": "Pain Control Measured by Pain Scale",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "40",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "spread": "1.33",
                        "groupId": "OG000"
                      },
                      {
                        "value": "2.4",
                        "spread": "1.4",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "timeFrame": "2 weeks postoperative",
            "description": "Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.",
            "unitOfMeasure": "score on a scale",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Pain Control Measured by the Use of Pain Pills Postoperatively",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "39",
                    "groupId": "OG000"
                  },
                  {
                    "value": "49",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "20",
                        "groupId": "OG000"
                      },
                      {
                        "value": "24",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "2 weeks postoperative",
            "description": "Participants who used narcotic pain pills postoperatively",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Paravertebral Block arm had one participant with no response"
          },
          {
            "type": "SECONDARY",
            "title": "Pain Control Measured by Calls to Physicians Office Relating to Pain",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "39",
                    "groupId": "OG000"
                  },
                  {
                    "value": "48",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Paravertebral Block",
                "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
              },
              {
                "id": "OG001",
                "title": "Pectoral Nerve Block",
                "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "title": "no phone calls to physician office regarding pain",
                    "measurements": [
                      {
                        "value": "38",
                        "groupId": "OG000"
                      },
                      {
                        "value": "44",
                        "groupId": "OG001"
                      }
                    ]
                  },
                  {
                    "title": "1 phone call to physician office regarding pain",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      },
                      {
                        "value": "4",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "2 weeks postoperative",
            "description": "Number of phone calls made to physician office regarding pain",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "one participant in each arm did not have a response recorded"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Paravertebral Block",
            "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
          },
          {
            "id": "FG001",
            "title": "Pectoral Nerve Block",
            "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "40"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "49"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "40"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "49"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "40",
                "groupId": "BG000"
              },
              {
                "value": "49",
                "groupId": "BG001"
              },
              {
                "value": "89",
                "groupId": "BG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Paravertebral Block",
            "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>"
          },
          {
            "id": "BG001",
            "title": "Pectoral Nerve Block",
            "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>"
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          {
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        ],
        "measures": [
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              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "65.15",
                        "spread": "10.18",
                        "groupId": "BG000"
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                        "value": "64.24",
                        "spread": "11.42",
                        "groupId": "BG001"
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                      {
                        "value": "64.65",
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                        "groupId": "BG002"
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            ],
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                        "value": "49",
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                        "value": "89",
                        "groupId": "BG002"
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                        "value": "0",
                        "groupId": "BG000"
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                        "value": "0",
                        "groupId": "BG001"
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                        "value": "0",
                        "groupId": "BG002"
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                  }
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            "paramType": "COUNT_OF_PARTICIPANTS",
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          },
          {
            "title": "Race (NIH&#x2F;OMB)",
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              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
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                      {
                        "value": "0",
                        "groupId": "BG001"
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                      {
                        "value": "0",
                        "groupId": "BG002"
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                  {
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                        "value": "0",
                        "groupId": "BG000"
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                      {
                        "value": "0",
                        "groupId": "BG001"
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                        "value": "0",
                        "groupId": "BG002"
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                  {
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                    "measurements": [
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                        "value": "0",
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                        "value": "0",
                        "groupId": "BG001"
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                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
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                  {
                    "title": "Black or African American",
                    "measurements": [
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                        "value": "1",
                        "groupId": "BG000"
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                        "value": "1",
                        "groupId": "BG001"
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                        "value": "2",
                        "groupId": "BG002"
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                        "groupId": "BG000"
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                      {
                        "value": "48",
                        "groupId": "BG001"
                      },
                      {
                        "value": "87",
                        "groupId": "BG002"
                      }
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                    "measurements": [
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                        "value": "0",
                        "groupId": "BG000"
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                        "value": "0",
                        "groupId": "BG001"
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                        "value": "0",
                        "groupId": "BG002"
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                        "groupId": "BG000"
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                      {
                        "value": "0",
                        "groupId": "BG001"
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                      {
                        "value": "0",
                        "groupId": "BG002"
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                  }
                ]
              }
            ],
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            "unitOfMeasure": "Participants"
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          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "categories": [
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                    "measurements": [
                      {
                        "value": "40",
                        "groupId": "BG000"
                      },
                      {
                        "value": "49",
                        "groupId": "BG001"
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                      {
                        "value": "89",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
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            "unitOfMeasure": "participants"
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