EX/EC Exposure Example 2

 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 sponsor used an electronic diary application to track when the cartigares were replaced, and the daily number of cigarettes smoked.  The subject used their normal brand of cigratees , and these were not supplied by the sponsor. 

Since, the subject regular cigarettes were not supplied by the sponsor, the sponor elected to report this data as a Concomitant medication, in the CM domain. THe ENDS device use was represented in EC.