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In this study, subjects were randomized to either nicotine replacement patches or ENDs device which used e ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devicedevices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied, at rotating sites, and the ENDS nicotine cartridge was replaced every day. The cartridge was weight weighed when dispended dispensed and upon return. On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers.   On these days, a new ENDS nicotine cartridge device was inserted and then used for 10 puffs were taken over 10 minutes, and then not used for 4 hoursthe remaining collection period. A new cartridge was insert inserted at the end of the 4 hours. The  -hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.     

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In this study, the weight of the contents in the cartridges were cartridge was tracked.   A Product Accountability (The DA ) domain was submitted used to represent dispensed and returned weights of the each cartridge each day.  Each cartridge had a uniquely assigned number. The sponsor used DAREFID that appeared on the label to identify the cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.    

EC was used to represent the collected exposure data since a double dummy -blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch.     The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.