Generated Narrative: ValueSet udp-section-codes-vs

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2
    CodeDisplayDefinition
    C222769ICH M11 Protocol Section Title PageTitle Page Section of the ICH M11 Protocol standard, Title Page.
    C218514ICH M11 Protocol Section 1 PROTOCOL SUMMARYThe title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY.
    C218515ICH M11 Protocol Section 1.1 Protocol SynopsisThe title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis.
    C218516ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and EstimandsThe title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands.
    C218517ICH M11 Protocol Section 1.1.2 Overall DesignThe title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design.
    C218518ICH M11 Protocol Section 1.2 Trial SchemaThe title of section 1.2 of the ICH M11 protocol guideline: Trial Schema.
    C218519ICH M11 Protocol Section 1.3 Schedule of ActivitiesThe title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities.
    C218520ICH M11 Protocol Section 2 INTRODUCTIONThe title of section 2 of the ICH M11 protocol guideline: INTRODUCTION.
    C218521ICH M11 Protocol Section 2.1 Purpose of TrialThe title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial.
    C218522ICH M11 Protocol Section 2.2 Assessment of Risks and BenefitsThe title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits.
    C218523ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation StrategyThe title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy.
    C218524ICH M11 Protocol Section 2.2.2 Benefit SummaryThe title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary.
    C218525ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit AssessmentThe title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment.
    C218526ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDSThe title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS.
    C218527ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s).
    C218528ICH M11 Protocol Section 3.1.1 Primary ObjectiveThe title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective.
    C218529ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s).
    C218530ICH M11 Protocol Section 3.2.1 Secondary ObjectiveThe title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective.
    C218531ICH M11 Protocol Section 3.3 Exploratory Objective(s)The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s).
    C218532ICH M11 Protocol Section 3.3.1 Exploratory ObjectiveThe title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective.
    C218533ICH M11 Protocol Section 4 TRIAL DESIGNThe title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN.
    C218534ICH M11 Protocol Section 4.1 Description of Trial DesignThe title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design.
    C218535ICH M11 Protocol Section 4.1.1 Stakeholder Input into DesignThe title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design.
    C218536ICH M11 Protocol Section 4.2 Rationale for Trial DesignThe title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design.
    C218537ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s).
    C218538ICH M11 Protocol Section 4.2.2 Rationale for Intervention ModelThe title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model.
    C218539ICH M11 Protocol Section 4.2.3 Rationale for Control TypeThe title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type.
    C218540ICH M11 Protocol Section 4.2.4 Rationale for Trial DurationThe title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration.
    C218541ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial DesignThe title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design.
    C218542ICH M11 Protocol Section 4.2.6 Rationale for Interim AnalysisThe title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis.
    C218543ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design AspectsThe title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects.
    C218544ICH M11 Protocol Section 4.3 Trial Stopping RulesThe title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules.
    C218545ICH M11 Protocol Section 4.4 Start of Trial and End of TrialThe title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial.
    C218546ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of TrialThe title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial.
    C218547ICH M11 Protocol Section 5 TRIAL POPULATIONThe title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION.
    C218548ICH M11 Protocol Section 5.1 Description of Trial Population and RationaleThe title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale.
    C218549ICH M11 Protocol Section 5.2 Inclusion CriteriaThe title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria.
    C218550ICH M11 Protocol Section 5.3 Exclusion CriteriaThe title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria.
    C218551ICH M11 Protocol Section 5.4 ContraceptionThe title of section 5.4 of the ICH M11 protocol guideline: Contraception.
    C218552ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing PotentialThe title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential.
    C218553ICH M11 Protocol Section 5.4.2 Contraception RequirementsThe title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements.
    C218554ICH M11 Protocol Section 5.5 Lifestyle RestrictionsThe title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions.
    C218555ICH M11 Protocol Section 5.5.1 Meals and Dietary RestrictionsThe title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions.
    C218556ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other RestrictionsThe title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions.
    C218557ICH M11 Protocol Section 5.5.3 Physical Activity RestrictionsThe title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions.
    C218558ICH M11 Protocol Section 5.5.4 Other Activity RestrictionsThe title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions.
    C218559ICH M11 Protocol Section 5.6 Screen Failure and RescreeningThe title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening.
    C218560ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPYThe title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY.
    C218561ICH M11 Protocol Section 6.1 Description of Investigational Trial InterventionThe title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention.
    C218562ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and RegimenThe title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen.
    C218563ICH M11 Protocol Section 6.3 Investigational Trial Intervention AdministrationThe title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration.
    C218564ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose ModificationThe title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification.
    C218565ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention OverdoseThe title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose.
    C218566ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial InterventionThe title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention.
    C218567ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial InterventionThe title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention.
    C218568ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial InterventionThe title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention.
    C218569ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial InterventionThe title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention.
    C218570ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and BlindingThe title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding.
    C218571ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial InterventionThe title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention.
    C218572ICH M11 Protocol Section 6.7.2 RandomisationThe title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation.
    C218573ICH M11 Protocol Section 6.7.3 Measures to Maintain BlindingThe title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding.
    C218574ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the SiteThe title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site.
    C218575ICH M11 Protocol Section 6.8 Investigational Trial Intervention AdherenceThe title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence.
    C218576ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial InterventionThe title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention.
    C218577ICH M11 Protocol Section 6.9.1 Background Trial InterventionThe title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention.
    C218578ICH M11 Protocol Section 6.9.2 Rescue TherapyThe title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy.
    C218579ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial InterventionThe title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention.
    C218580ICH M11 Protocol Section 6.10 Concomitant TherapyThe title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy.
    C218581ICH M11 Protocol Section 6.10.1 Prohibited Concomitant TherapyThe title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy.
    C218582ICH M11 Protocol Section 6.10.2 Permitted Concomitant TherapyThe title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy.
    C218583ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIALThe title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL.
    C218584ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual ParticipantsThe title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants.
    C218585ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial InterventionThe title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention.
    C218586ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial InterventionThe title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention.
    C218587ICH M11 Protocol Section 7.1.3 RechallengeThe title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge.
    C218588ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the TrialThe title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial.
    C218589ICH M11 Protocol Section 7.3 Management of Loss to Follow-UpThe title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up.
    C218590ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURESThe title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES.
    C218591ICH M11 Protocol Section 8.1 Trial Assessments and Procedures ConsiderationsThe title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations.
    C218592ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and ProceduresThe title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures.
    C218593ICH M11 Protocol Section 8.3 Efficacy Assessments and ProceduresThe title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures.
    C218594ICH M11 Protocol Section 8.4 Safety Assessments and ProceduresThe title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures.
    C218595ICH M11 Protocol Section 8.4.1 Physical ExaminationThe title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination.
    C218596ICH M11 Protocol Section 8.4.2 Vital SignsThe title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs.
    C218597ICH M11 Protocol Section 8.4.3 ElectrocardiogramsThe title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms.
    C218598ICH M11 Protocol Section 8.4.4 Clinical Laboratory AssessmentsThe title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments.
    C218599ICH M11 Protocol Section 8.4.5 Pregnancy TestingThe title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing.
    C218600ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk MonitoringThe title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring.
    C218601ICH M11 Protocol Section 8.5 PharmacokineticsThe title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics.
    C218602ICH M11 Protocol Section 8.6 BiomarkersThe title of section 8.6 of the ICH M11 protocol guideline: Biomarkers.
    C218603ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and PharmacogenomicsThe title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics.
    C218604ICH M11 Protocol Section 8.6.2 Pharmacodynamic BiomarkersThe title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers.
    C218605ICH M11 Protocol Section 8.6.3 Other BiomarkersThe title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers.
    C218606ICH M11 Protocol Section 8.7 Immunogenicity AssessmentsThe title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments.
    C218607ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health EconomicsThe title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics.
    C218608ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONSThe title of section 9 of the ICH M11 protocol guideline: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS.
    C218609ICH M11 Protocol Section 9.1 DefinitionsThe title of section 9.1 of the ICH M11 protocol guideline: Definitions.
    C218610ICH M11 Protocol Section 9.1.1 Definitions of Adverse EventsThe title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events.
    C218611ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse EventsThe title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events.
    C218612ICH M11 Protocol Section 9.1.3 Definitions of Product ComplaintsThe title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints.
    C218613ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product ComplaintsThe title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints.
    C218614ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and ReportingThe title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting.
    C218615ICH M11 Protocol Section 9.2.1 TimingThe title of section 9.2.1 of the ICH M11 protocol guideline: Timing.
    C218616ICH M11 Protocol Section 9.2.2 Collection ProceduresThe title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures.
    C218617ICH M11 Protocol Section 9.2.3 ReportingThe title of section 9.2.3 of the ICH M11 protocol guideline: Reporting.
    C218618ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting RequirementsThe title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements.
    C218619ICH M11 Protocol Section 9.2.4 Adverse Events of Special InterestThe title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest.
    C218620ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEsThe title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs.
    C218621ICH M11 Protocol Section 9.3 Pregnancy and Postpartum InformationThe title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information.
    C218622ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the TrialThe title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial.
    C218623ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the TrialThe title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial.
    C218624ICH M11 Protocol Section 9.4 Special Safety SituationsThe title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations.
    C218625ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONSThe title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS.
    C218626ICH M11 Protocol Section 10.1 General ConsiderationsThe title of section 10.1 of the ICH M11 protocol guideline: General Considerations.
    C218627ICH M11 Protocol Section 10.2 Analysis SetsThe title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets.
    C218628ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline VariablesThe title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables.
    C218629ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s).
    C218630ICH M11 Protocol Section 10.4.1 Primary ObjectiveThe title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective.
    C218631ICH M11 Protocol Section 10.4.1.1 Statistical Analysis MethodThe title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
    C218632ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s).
    C218633ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s)
    C218634ICH M11 Protocol Section 10.4.1.4 Sensitivity AnalysisThe title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
    C218635ICH M11 Protocol Section 10.4.1.5 Supplementary AnalysisThe title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
    C218636ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s).
    C218637ICH M11 Protocol Section 10.5.1 Secondary ObjectiveThe title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective.
    C218638ICH M11 Protocol Section 10.5.1.1 Statistical Analysis MethodThe title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
    C218639ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s).
    C218640ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s).
    C218641ICH M11 Protocol Section 10.5.1.4 Sensitivity AnalysisThe title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
    C218642ICH M11 Protocol Section 10.5.1.5 Supplementary AnalysisThe title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
    C218643ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s).
    C218644ICH M11 Protocol Section 10.7 Safety AnalysesThe title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses.
    C218645ICH M11 Protocol Section 10.8 Other AnalysesThe title of section 10.8 of the ICH M11 protocol guideline: Other Analyses.
    C218646ICH M11 Protocol Section 10.9 Interim AnalysesThe title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses.
    C218647ICH M11 Protocol Section 10.10 Multiplicity AdjustmentsThe title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments.
    C218648ICH M11 Protocol Section 10.11 Sample Size DeterminationThe title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination.
    C218649ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONSThe title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.
    C218650ICH M11 Protocol Section 11.1 Regulatory and Ethical ConsiderationsThe title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations.
    C218651ICH M11 Protocol Section 11.2 Trial OversightThe title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight.
    C218652ICH M11 Protocol Section 11.2.1 Investigator ResponsibilitiesThe title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities.
    C218653ICH M11 Protocol Section 11.2.2 Sponsor ResponsibilitiesThe title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities.
    C218654ICH M11 Protocol Section 11.3 Informed Consent ProcessThe title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process.
    C218655ICH M11 Protocol Section 11.3.1 Informed Consent for RescreeningThe title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening.
    C218656ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory ResearchThe title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research.
    C218657ICH M11 Protocol Section 11.4 CommitteesThe title of section 11.4 of the ICH M11 protocol guideline: Committees.
    C218658ICH M11 Protocol Section 11.5 Insurance and IndemnityThe title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity.
    C218659ICH M11 Protocol Section 11.6 Risk-Based Quality ManagementThe title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management.
    C218660ICH M11 Protocol Section 11.7 Data GovernanceThe title of section 11.7 of the ICH M11 protocol guideline: Data Governance.
    C218661ICH M11 Protocol Section 11.8 Data ProtectionThe title of section 11.8 of the ICH M11 protocol guideline: Data Protection.
    C218662ICH M11 Protocol Section 11.9 Source RecordsThe title of section 11.9 of the ICH M11 protocol guideline: Source Records.
    C218663ICH M11 Protocol Section 11.10 Protocol DeviationsThe title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations.
    C218664ICH M11 Protocol Section 11.11 Early Site ClosureThe title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure.
    C218665ICH M11 Protocol Section 11.12 Data DisseminationThe title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination.
    C218666ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILSThe title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS.
    C218667ICH M11 Protocol Section 12.1 Clinical Laboratory TestsThe title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests.
    C218668ICH M11 Protocol Section 12.2 Country/Region-Specific DifferencesThe title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences.
    C218669ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s).
    C218670ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONSThe title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS.
    C218671ICH M11 Protocol Section 14 APPENDIX: REFERENCESThe title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES.
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