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In this study, subjects were randomized to either nicotine replacement patches or ENDs device which used e nicotine liquid. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS device. 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 cartridge was replaced every day. The cartridge was weight weighed when dispended dispensed and upon return. On days, 1, 5, 10 subjects remained in the clinic for 4 hours for collection of biomarkers.  On these days, a new ENDS cartridge device was inserted and then used for 10 minutes, and then not used for 4 hours. A new cartridge was insert at the end of 4 hours. The  patch was applied prior to using the ENDS device on these days.     

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

 Subject 10001 was randomized to the 5%  pharmaceutical strength of the e- nicotine liquid, and subject 20001 was randomized to the active nicotine patch with a pharmaceutical strength of 14mg. The sponsor only represented the active product exposure for each subject in EX. .