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At least 1 product variable is required in a BDS dataset. This requirement is satisfied by any of the subject-level product variables (e.g., TRTxxP) or record- level product variables (e.g., TRTP). All product variables defined in ADaMIG Table 3.3.2.1 are record level, meaning that the values contained in the variable may vary by record within a subject. Subject-level product variables are described in Section 2.9.5.4, Product Variables for ADSL Datasets.

All dose variables defined in the following table are record level. This means that the values contained in the variable may vary by record within a subject. These record-level dose variables, plus ADSL subject-level dose variables, can be used in addition to—but not instead of—record-level product variables.