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In this study, the subject subjects were assigned randomized to one of three different ENDS products . In this study,  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/g of ml nicotine liquid. Self-reported daily cigarette consumption  were measured at all study visits  (Weeks 2, 4, 8, 12 )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 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 and NRT used.  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 40 mg.   The subject 8 mL. No other nicotine replacement products were allowed to continue the used of their regular cigarettes, and use Nicotine Replacement therapy (Gum, patches, etc) as neededbe used. Multiple cartridges were dispensed at a visit.   

The sponsor decided to represent the data reported on the study product usage collect in the diary in the Exposure as collected (EC) domain. Any cigarette usage was reported in the SU domain, and any other nicotine replacement therapy ( patches, smokeless tobacco etc) were represented in the CM domain. The tobacco study product accountability was reported in the Product Accountability (DA) domain.  The subject were provided cartridges at each visit depending on the number of cigarettes used per day prior to study start.  Heavy smokers were provided more cartridges at each dispensing visit then other smokers. The visits were 1 week apart. The cartridge were designed to last a non-heavy smoker a day. 10 cartridges were dispensed for non-heavy smokers , and 14  cartridges were dispensed to heavy smokers. All cartridges were labeled TEST PRODUCT.    

This is an example of the subject's diary.    

This data was represented in the EC domain and Product Accountability domains.   The sponsor was only interested in the total number of cartridges used per week The investigator and the subject reviewed the diary at each visit, with the dispensed and return amount to verify the data.          

All cartridges dispensed weight  40 mg grams at the time of dispensing. The weight of each cartridge was weight at return.  The total weight used for the week was represented in EXDOSE. 

applicant represented the cigarettes used in the SU domain. 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 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 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 associated nicotine pharmaceutical strength of each cartridge was known. The 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.