EX/EC Exposure Example 2 (ENDS)

In this study, the subject were assigned to one of three different ENDS products . In this study,  At the baseline visit, they receiving either an ENDS  device that used  0, 8 or 36 mg/g of nicotine. Self-reported daily cigarette consumption  were measured at all study visits  (Weeks 2, 4, 8, 12 ). The subjects were supplied replacement nicotine cartridges.  The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked and NRT used.  The subject used their normal brand cigarettes , and these were not supplied by the sponsor. Each cartridge was 40 mg.   The subject were allowed to continue the used of their regular cigarettes, and use Nicotine Replacement therapy (Gum, patches, etc) as needed.   

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.