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 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.        

 

ec.xpt

ec.xpt

RowSTUDYIDDOMAINUSUBJIDECSEQECTRTECDOSEECDOSUEXROUTEECSTDTCECENDTC
1TENDS01EC10001 1Electronic Nicotine Delivery System  1CONTAINERINHALED2020-06-272020-07-01
2TENDS01EC10001 2Electronic Nicotine Delivery System 1CONTAINERINHALED2020-07-012020-07-05
3TENDS01EC10001 3Electronic Nicotine Delivery System 1CONTAINERINHALED2020-07-052020-07-10
4TENDS01EC100021Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-012020-09-07
5TENDS01EC10002 2Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-072020-09-14
6TENDS01EC10002 3Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-142020-09-21
7TENDS01EC10002 4Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-212020-09-28
8TENDS01EC10002 5Electronic Nicotine Delivery System 1CONTAINERINHALED2020-09-282020-09-31
9TENDS01EC10002 6Electronic Nicotine Delivery SystemP1CONTAINERINHALED2020-10-312020-10-08
10TENDS01EC10002 7Electronic Nicotine Delivery System 1CONTAINERINHALED2020-10-082020-10-15
11TENDS01EC10002 8Electronic Nicotine Delivery System 1CONTAINERINHALED2020-10-152020-10-22

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