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In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS  device that used  0, 8 or 36 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product.  Each cartridge was 8 mL.   No other Nicotine replacement products were allowed to be used.   Multiple cartridges were dispensed at a visit.   

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In this study,  the volume of the contents in the cartridges were being accounted for.  A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. This unique number was represented in DAREFThe sponsor used  DAREFID  that appeared on the label to identify the cartridge. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed.  Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed.  Cartridges A returned cartridges that was not used were record was recorded as having the full volume returned.       

 Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.  

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