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This is a study where subjects were randomized to 3 different concentrations of nicotine e-nicotine liquid, or their usual brand of cigarettes. The subject 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 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 the level , was too high, the visit was re-scheduledrescheduled. Subjects 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. 

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

The sponsor applicant submitted the EX domain to represent the usage Exposure (EX) domain to represent use of the tobacco product. For each subject, the usage Usage for the two 2-week period are is represented , and then for each subject, along with the specified usage use during the in-clinic visit are shown. The sponsor applicant elected not to represent each puff in this EX dataset. Each Puff , 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, the sponsor derives applicants derive 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 applicant created an ADaM dataset to represent the summary data ( Not Shownnot shown). 

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

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