In this study, subjects were randomized to one of three 24-week conditions. At the baseline visit, they receiving either an ENDS device that used 0, 8 or 36 mg/ml nicotine liquid . Self-reported daily cigarette consumption were measured at all study visits (Weeks 1, 2, 4, 8, 12, ). The subjects were supplied replacement nicotine cartridges. The start and end date of the use of each cartridge was collected. Other nicotine, or nicotine replacement therapy use was no collected.
IN this study, the sponsor elected to submit only the EX domain as the data for each dispensed cartridge was reported.
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