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The FAEX domain was used to represent the puff topography associated with the in-clinic visit. The Findings About Events or Interventions structure (or "FA structure") is used to represent collected data that are findings about” an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.

A puff-by puff analysis was performed. FATPT was used to represent the time point, in this case, AM and PM. Typically, the sponsor derives summary results using the individual source data records; these summary results are represented in ADaM. However, if summary results are collected on a CRF or provided by an external vendor, these derived results can be represented in FAEX using the variable FACOLSRT. In this example, the sponsor created an ADaM dataset to represent the summary data ( Not Shown). 

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