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In tobacco product studies, the Adverse Events (AE) domain is used for representing adverse experiences. The FDA's PMTA rule defines adverse experience as any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product. In consultation with regulatory authorities, applicants may extend or limit the scope of collection (e.g., collecting pre-treatment experiences related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirementsIt is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. Adverse events may be captured either as free text or via a prespecified list of terms.

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