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This is a study were where subjects were randomized to use 3 different concentration concentrations of nicotine e-nicotine liquid. The subject were confined to a clinical after using , or their usual brand of cigarettes. The subjects used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two 2 weeks, the subjects were confined to the clinical clinic for one 1 day. They were required to not use any  e-cigarettes any tobacco products for 12 hours prior to the visit. Subjects had to have CO level levels below a pre-specified prespecified level , to attend the visit.   IF If the level , was too high, the visit ws re-scheduledwas rescheduled. Subjects were  were instructed to take 10 puffs on the e-cigarette/usual brand of cigarettes in the morning and afternoon. Puff topography was measured in the morning and afternoon using the same device for all subjects. Subjects were not allowed to use any tobacco products between the morning and afternoon sessions. 

Device Identifiers (DI), a Study Reference domain, was used to identify the device used to measure puff topography. This provides a consistent variable (SPDEVID) for linking data. Because device identifiers exist independently from subjects, the DI domain does not contain USUBJID. Only 1 device was used for all subjects in the study. 

The applicant submitted the Exposure (EX) domain to represent use of the tobacco product. Usage for the 2-week period is represented for each subject, along with the specified use during the in-clinic visit. The applicant elected not to represent each puff in this EX dataset, although each puff could have been recorded.       

The FAEX domain was used to represent the puff topography associated with the in-clinic visit. The Findings About Events or Interventions structure ("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. Only selected data for puffs 1 and 10 are shown. No data are shown for 2-9 to simplify dataset review. FATPT was used to represent the time point (in this case, AM and PM). Typically, applicants derive summary results using 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 applicant created an ADaM dataset to represent the summary data (not shown). 

The RELREC dataset was used to record the relationship between the records in EX and the records in FAEX.