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1. A set of analysis timing variables can be included in ADSL only if the definitions for all of the variables in the set are fixed across the study (i.e., the definitions of the start and end of each timing element for a given subject do not change based on endpoint or data type). The first such set consists of all of the analysis period timing variables defined in ADSL Subject-Level Period, Subperiod, and Phase Timing Variables. The second set consists of all of the subperiod timing variables in that table. The third set consists of all of the phase timing variables in that table.
2. If period timing variables are not included in ADSL, then subperiod timing variables must be excluded from
3. If any of the definitions of the variables in the set do vary, for example, when analysis period start or stop date definitions differ for safety and efficacy analyses, then none of the variables in the set can be included in ADSL.
4. If all of the variable definitions in the set are the same across all datasets, then they can be included in Timing Variables for BDS Datasets specifies variables to be used in the other datasets when definitions differ by dataset.