{
  "FullStudy":{
    "Rank":217860,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515891",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BIA-91067-103"
          },
          "Organization":{
            "OrgFullName":"Bial - Portela C S.A.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites",
          "OfficialTitle":"An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2009",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "ResultsFirstSubmitDate":"December 30, 2014",
          "ResultsFirstSubmitQCDate":"December 30, 2014",
          "ResultsFirstPostDateStruct":{
            "ResultsFirstPostDate":"January 9, 2015",
            "ResultsFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 30, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 9, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Bial - Portela C S.A.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"To determine the absorption, metabolism and excretion of BIA 9-1067.",
          "DetailedDescription":"Monocentre, open, non-placebo-controlled, single-group, single-dose study"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Parkinson Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Parkinson Disease",
              "BIA 9-1067"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"4",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"BIA 9-1067",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: BIA 9-1067"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"BIA 9-1067",
                "InterventionDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "BIA 9-1067"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Opicapone"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Maximum Plasma Concentration (Cmax)",
                "PrimaryOutcomeDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "PrimaryOutcomeTimeFrame":"24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Time to Reach Maximum Plasma Concentration (Tmax)",
                "SecondaryOutcomeDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "SecondaryOutcomeTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose"
              },{
                "SecondaryOutcomeMeasure":"Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)",
                "SecondaryOutcomeDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "SecondaryOutcomeTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose"
              },{
                "SecondaryOutcomeMeasure":"Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)",
                "SecondaryOutcomeDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "SecondaryOutcomeTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy Caucasian male subjects, 40-55 years of age.\nSitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 - 160 mmHg systolic, 50 - 95 mmHg diastolic and pulse rate: 50 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.\nSubject body mass index was to be between 18 and 28 kg/m2\nNormal 12-lead ECG\nAbility to communicate well with the investigator and comply with the requirements of the entire study.\nThe subject had given his written informed consent to participate in the study.\n\nExclusion Criteria:\n\nHistory of serious adverse reactions or hypersensitivity to any drug.\nPresence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).\nHistory of alcohol or drug abuse in the last 5 years.\nAbnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.\nNeed of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.\nParticipation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.\nLoss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.\nExistence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.\nSymptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.\nHistory of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.\nPositive results from the HIV serology.\nClinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.\nPositive results of the drug screening.\nKnown hypersensitivity to BIA 9-1067.\nHeavy smokers, i.e., more than 10 cigarettes per day\nExposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)\nSubject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"40 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Seiberling Michael, MD",
                "OverallOfficialAffiliation":"Covance",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Covance Basel Research Unit AG (formerly Swiss Pharma Contract Ltd)",
                "LocationCity":"Allschwil",
                "LocationState":"Base",
                "LocationZip":"CH-4123",
                "LocationCountry":"Switzerland"
              }
            ]
          }
        }
      },
      "ResultsSection":{
        "ParticipantFlowModule":{
          "FlowGroupList":{
            "FlowGroup":[
              {
                "FlowGroupId":"FG000",
                "FlowGroupTitle":"BIA 9-1067",
                "FlowGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
              }
            ]
          },
          "FlowPeriodList":{
            "FlowPeriod":[
              {
                "FlowPeriodTitle":"Overall Study",
                "FlowMilestoneList":{
                  "FlowMilestone":[
                    {
                      "FlowMilestoneType":"STARTED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"4"
                          }
                        ]
                      }
                    },{
                      "FlowMilestoneType":"COMPLETED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"4"
                          }
                        ]
                      }
                    },{
                      "FlowMilestoneType":"NOT COMPLETED",
                      "FlowAchievementList":{
                        "FlowAchievement":[
                          {
                            "FlowAchievementGroupId":"FG000",
                            "FlowAchievementNumSubjects":"0"
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "BaselineCharacteristicsModule":{
          "BaselineGroupList":{
            "BaselineGroup":[
              {
                "BaselineGroupId":"BG000",
                "BaselineGroupTitle":"BIA 9-1067",
                "BaselineGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
              }
            ]
          },
          "BaselineDenomList":{
            "BaselineDenom":[
              {
                "BaselineDenomUnits":"Participants",
                "BaselineDenomCountList":{
                  "BaselineDenomCount":[
                    {
                      "BaselineDenomCountGroupId":"BG000",
                      "BaselineDenomCountValue":"4"
                    }
                  ]
                }
              }
            ]
          },
          "BaselineMeasureList":{
            "BaselineMeasure":[
              {
                "BaselineMeasureTitle":"Age, Categorical",
                "BaselineMeasureParamType":"Count of Participants",
                "BaselineMeasureUnitOfMeasure":"Participants",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineCategoryTitle":"<=18 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"0"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":"Between 18 and 65 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"4"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":">=65 years",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"0"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "BaselineMeasureTitle":"Sex: Female, Male",
                "BaselineMeasureParamType":"Count of Participants",
                "BaselineMeasureUnitOfMeasure":"Participants",
                "BaselineClassList":{
                  "BaselineClass":[
                    {
                      "BaselineCategoryList":{
                        "BaselineCategory":[
                          {
                            "BaselineCategoryTitle":"Female",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"0"
                                }
                              ]
                            }
                          },{
                            "BaselineCategoryTitle":"Male",
                            "BaselineMeasurementList":{
                              "BaselineMeasurement":[
                                {
                                  "BaselineMeasurementGroupId":"BG000",
                                  "BaselineMeasurementValue":"4"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "OutcomeMeasuresModule":{
          "OutcomeMeasureList":{
            "OutcomeMeasure":[
              {
                "OutcomeMeasureType":"Primary",
                "OutcomeMeasureTitle":"Maximum Plasma Concentration (Cmax)",
                "OutcomeMeasureDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"ng-eq/mL",
                "OutcomeMeasureTimeFrame":"24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"BIA 9-1067",
                      "OutcomeGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"4"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"482.98",
                                  "OutcomeMeasurementSpread":"265.26"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "OutcomeMeasureType":"Secondary",
                "OutcomeMeasureTitle":"Time to Reach Maximum Plasma Concentration (Tmax)",
                "OutcomeMeasureDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"hours",
                "OutcomeMeasureTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"BIA 9-1067",
                      "OutcomeGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"4"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"1.69",
                                  "OutcomeMeasurementSpread":"0.75"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "OutcomeMeasureType":"Secondary",
                "OutcomeMeasureTitle":"Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)",
                "OutcomeMeasureDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"h⋅ng-eq/mL",
                "OutcomeMeasureTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"BIA 9-1067",
                      "OutcomeGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"4"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"14038.27",
                                  "OutcomeMeasurementSpread":"4823.78"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              },{
                "OutcomeMeasureType":"Secondary",
                "OutcomeMeasureTitle":"Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)",
                "OutcomeMeasureDescription":"Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites",
                "OutcomeMeasureReportingStatus":"Posted",
                "OutcomeMeasureParamType":"Mean",
                "OutcomeMeasureDispersionType":"Standard Deviation",
                "OutcomeMeasureUnitOfMeasure":"h⋅ng-eq/mL",
                "OutcomeMeasureTimeFrame":"24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose",
                "OutcomeGroupList":{
                  "OutcomeGroup":[
                    {
                      "OutcomeGroupId":"OG000",
                      "OutcomeGroupTitle":"BIA 9-1067",
                      "OutcomeGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
                    }
                  ]
                },
                "OutcomeDenomList":{
                  "OutcomeDenom":[
                    {
                      "OutcomeDenomUnits":"Participants",
                      "OutcomeDenomCountList":{
                        "OutcomeDenomCount":[
                          {
                            "OutcomeDenomCountGroupId":"OG000",
                            "OutcomeDenomCountValue":"4"
                          }
                        ]
                      }
                    }
                  ]
                },
                "OutcomeClassList":{
                  "OutcomeClass":[
                    {
                      "OutcomeCategoryList":{
                        "OutcomeCategory":[
                          {
                            "OutcomeMeasurementList":{
                              "OutcomeMeasurement":[
                                {
                                  "OutcomeMeasurementGroupId":"OG000",
                                  "OutcomeMeasurementValue":"33441.69",
                                  "OutcomeMeasurementSpread":"14069.06"
                                }
                              ]
                            }
                          }
                        ]
                      }
                    }
                  ]
                }
              }
            ]
          }
        },
        "AdverseEventsModule":{
          "EventsFrequencyThreshold":"0",
          "EventGroupList":{
            "EventGroup":[
              {
                "EventGroupId":"EG000",
                "EventGroupTitle":"BIA 9-1067",
                "EventGroupDescription":"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).\n\nBIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).",
                "EventGroupSeriousNumAffected":"0",
                "EventGroupSeriousNumAtRisk":"4",
                "EventGroupOtherNumAffected":"3",
                "EventGroupOtherNumAtRisk":"4"
              }
            ]
          },
          "OtherEventList":{
            "OtherEvent":[
              {
                "OtherEventTerm":"Tiredness",
                "OtherEventOrganSystem":"General disorders",
                "OtherEventSourceVocabulary":"MedDRA",
                "OtherEventStatsList":{
                  "OtherEventStats":[
                    {
                      "OtherEventStatsGroupId":"EG000",
                      "OtherEventStatsNumAffected":"2",
                      "OtherEventStatsNumAtRisk":"4"
                    }
                  ]
                }
              },{
                "OtherEventTerm":"Headache",
                "OtherEventOrganSystem":"Nervous system disorders",
                "OtherEventStatsList":{
                  "OtherEventStats":[
                    {
                      "OtherEventStatsGroupId":"EG000",
                      "OtherEventStatsNumAffected":"2",
                      "OtherEventStatsNumAtRisk":"4"
                    }
                  ]
                }
              },{
                "OtherEventTerm":"Flatulence",
                "OtherEventOrganSystem":"Gastrointestinal disorders",
                "OtherEventStatsList":{
                  "OtherEventStats":[
                    {
                      "OtherEventStatsGroupId":"EG000",
                      "OtherEventStatsNumAffected":"1",
                      "OtherEventStatsNumAtRisk":"4"
                    }
                  ]
                }
              },{
                "OtherEventTerm":"Loose stools",
                "OtherEventOrganSystem":"Gastrointestinal disorders",
                "OtherEventStatsList":{
                  "OtherEventStats":[
                    {
                      "OtherEventStatsGroupId":"EG000",
                      "OtherEventStatsNumAffected":"1",
                      "OtherEventStatsNumAtRisk":"4"
                    }
                  ]
                }
              }
            ]
          }
        },
        "MoreInfoModule":{
          "CertainAgreement":{
            "AgreementPISponsorEmployee":"No",
            "AgreementRestrictionType":"OTHER",
            "AgreementRestrictiveAgreement":"Yes"
          },
          "PointOfContact":{
            "PointOfContactTitle":"Head of Clinical Research",
            "PointOfContactOrganization":"Bial – Portela & Cª, S.A.",
            "PointOfContactEMail":"jose.rocha@bial.com",
            "PointOfContactPhone":"+351 229 866 100"
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000549349",
                "InterventionMeshTerm":"Opicapone"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000065098",
                "InterventionAncestorTerm":"Catechol O-Methyltransferase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000978",
                "InterventionAncestorTerm":"Antiparkinson Agents"
              },{
                "InterventionAncestorId":"D000018726",
                "InterventionAncestorTerm":"Anti-Dyskinesia Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M235343",
                "InterventionBrowseLeafName":"Opicapone",
                "InterventionBrowseLeafAsFound":"BIA 9-1067",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2876",
                "InterventionBrowseLeafName":"Antiparkinson Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T373",
                "InterventionBrowseLeafName":"Catechol",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnDyAg",
                "InterventionBrowseBranchName":"Anti-Dyskinesia Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Ot",
                "InterventionBrowseBranchName":"Other Dietary Supplements"
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            ]
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