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In this study, subjects were randomized to nicotine lozenges or placebo. Subject were allowed to smoke cigarettes.    1 of 3 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 applicant used an e-diary to track when cartridges were inserted and removed, and the daily number of cigarettes smoked. Subjects used their normal brand of cigarettes; these were not supplied by the applicant, and are 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 applicant represented the cigarettes used in the SU domain. After the first visit, the The sponsor reported 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, a (although "0" records are typically not included), 0 was recorded as the data was collected.   Only a few rows are shown.    

In this study,  lozenges that had a strength of 4mg were usedwere the cartridges were being accounted for.  A Product Accountability (DA) domain was submitted The DA domain was used to represent dispensed and returned amounts. Each The ENDS product used in the study was assigned a product identifier (VAPE-Z27), and each cartridge had a uniquely assigned number. The sponsor used  DAREFID  that appeared on the label to identify the cartridgeThis 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.   A returned cartridges that was Cartridges not used was were 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 amount of liquid product used from each cartridge was determined using the data in the DA domain. The 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 determined from the DA domain and 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  analysis were the estimated number of cartridges used per week, and the estimated nicotine exposer exposure from the cartridges per day.