In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they received an ENDS device that used 0, 8 or 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption was 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 cartridges were inserted and removed, 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.
The sponsor represented the cigarettes used in the in the SU domain. The number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, 0 was recorded as the data was collected. Only a few rows are shown.
A Product Accountability domain was submitted to represent dispensed and returned amounts. The ENDS product used in the study was assigned a Sponsor Tobacco Product Identifier (VAPE-Z27) and each cartridge had a uniquely assigned number. This unique number was represented in DAREFID. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispensed 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 not used were recorded as having the full volume returned.
Since the data in Exposure as Collected (EC) would be practically identical 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.
The sponsor used an electronic diary to collect the start and end date of the insertion and removal date of each cartridge in the ENDS device. For simplicity, in this example, the actual times of insertion/removal were not collected, but may often be collected.
The domain represented the total amount of liquid product used from each cartridge which was determined using the data in the DA domain. The associated nicotine pharmaceutical strength of each cartridge was known. The sponsored used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposure from the cartridges per day.
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