Page History

This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any  e-cigarettes for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit.  If the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette 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  Study Reference domain, DI, was used to identify the device used to measure puff topography.  The provide a consistent sponsor-defined variable (SPDEVID) for linking data. Device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one device was used for all subjects in the study. 

...

The FAEX domain was used to represent the puff topography associated with the in-clinic visit.  A puff -by puff analysis was performed. Additionally . FATPT was used to represent the time point, in this case, AM and PM.  Additonally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.  of the measurements of 10 puffs in the mornings, and also in the afternoon. These derived means are included because they were provided by the vendor. If the sponsor had calculated the means, then these results would be represented in an ADaM datset .