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• Sponsors may use terms like concomitant medications, treatments, or therapies, as appropriate for the study. The following text may use one of these terms, but sponsors can always use the term most appropriate for their study.
• The term prior refers to medications/treatments that were started before study participation, because limited information may be available on prior medications taken by a subject; the core requirements were constrained to reflect this limitation.
• Sponsors should define the appropriate collection period for prior and concomitant medications/treatments in the study protocol.

Specification

Assumptions

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