All clincal studies, including studies on tobacco products, collect general information about a subject/participant. The section shows information typically collected in ll clincial studies. For example, study disposition, demographic and subject characteristic information ( e.g., Sex, Age), information about prior tobacco product usage, safety laboratory tests and medical history. Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.
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