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In this study, subjects were randomized to one 1 of three 3 nicotine dosage levels. At the baseline visit (Week week 0), they receiving received an ENDS device that used  used 0, 8, or 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were was recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor applicant used an electronic e-diary application to track when the cartridges were replacedinserted and removed, and the daily number of cigarettes smoked. The subject Subjects used their normal brand of cigarettes, and ; these were not supplied by the sponsorapplicant, and are not considered a study product.   Each cartridge was 8 mL.   No other Nicotine nicotine replacement products were allowed to be used.   Multiple cartridges were dispensed at a visit.   

The sponsor reported applicant represented the cigarettes used in the in the SU domain. The After the first visit, the number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, a (although "0" records are typically not included), 0 was recorded as the data was collected.   Only a few rows are shown.    

A Product Accountability The DA domain was submitted used to represent dispensed and returned amounts. The ENDS product used in the study was assigned aSponsor Tobacco Product Identifier product identifier (VAPE-Z27) and , and each cartridge had a uniquely assigned number. This unique number was represented in DAREFID. Multiple cartridges were dispensed at weekly visits, but and each cartridge was tracked. At each weekly visit, all previously dispended 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 record recorded as having the full volume returned.       

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

The applicant used an e-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, although this may often be collected.    

The total domain represented the number of cartridges used (in this example always 1 since each cartridge was tracked), the total amount amount of liquid product used from each cartridge was determined from using the data in the DA domain and the . The associated nicotine pharmaceutical strength of each cartridge was known. The sponsored applicant 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.