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This article provides information on the ISO international standard for country codes is ISO-3166, which provides several representations of names for countries (ISO-3166-1) and their subdivisions (ISO-3166-2).

Standard(s)SDTMIG

Sexual Orientation & Gender Identity (SOGI)

eCRF

Summary of Observed and Change from Baseline by Scheduled Visits - Chemistry Laboratory Test

Summary of Observed and Change from Baseline by Scheduled Visits - Hematology Laboratory Test

Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs

Overview of Adverse Events

Subjects With Adverse Events Leading to Treatment Discontinuation by System Organ Class and Preferred Term

Subjects With Serious Adverse Events by System Organ Class and Preferred Term

Subjects With Common Adverse Events Occurring at ≥X% Frequency

Subjects With Adverse Events by System Organ Class and Preferred Term

Baseline Demographic and Clinical Characteristics