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In this study, subjects were randomized to one of three 24-week conditions.  1 of 3 nicotine dosage levels. At the baseline visit (week 0), they receiving either received an ENDS  ENDS device that used  used 0, 8, or 36 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were measured at all study visits  (Weeks 1, 2, 4, 8, 12, )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 cartridge were replacedcartridges were inserted 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 applicant represented The subject regular cigarettes were not supplied by the sponsor, and not considered a study product by the sponsor.  The sponsor reported the cigarettes used in the in the SU domain.   The SU domain is not shown here, but an example is shown in xxxxxx. 

Since the data in Exposure as collected would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain.  A Product Accountability domain was submitted to represent dispensed and returned amounts, but this data was not used in determining exposure. It was used by the sponsor when reviewing the exposure data for each subject. This DA domain is not shown here.    

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

The DA domain was used to represent dispensed and returned amounts. The ENDS product used in the study was assigned a 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, and 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.     

Because the data in EC would be practically identical to the summarized EX domain, the applicant did not submit the EC domain. The applicant Note, the sponsor 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 amount of product used, the total amount amount of liquid product ( including all is components) used from each cartridge and the was determined using the data in the DA domain. 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.    

Since the data in Exposure as collected would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain.  The DA domain was used to capture the amount of nicotine dispensed and returned for each cartridge. 

Note, the sponsor unblinded the study before creating the EX domain. The unblinded product name is used in EXTRT.