In this study, subjects were randomized to one of three 24-week conditions. At the baseline visit, they receiving either an ENDS device that 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 cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand of cigratees cigarettes , and these were not supplied by the sponsor. Each cartridge was 8 mL.
Since, the subject regular cigarettes were not supplied by the sponsor, the sponor sponsor elected to report this data as a Concomitant medication, in the CM domain. THe ENDS device use was represented in EC.
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | EXROUTEECROUTE | ECSTDTC | ECENDTC |
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1 | TENDS01 | EC | 10001 | 1 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-06-27 | 2020-07-01 | 2 | TENDS01 | EC | 10001 | 2 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-07-01 | 2020-07-05 | 3 | TENDS01 | EC | 10001 | 3 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-07-05 | 2020-07-10 | 4 | TENDS01 | EC | 10002 | 1 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-01 | 2020-09-07 | 5 | TENDS01 | EC | 10002 | 2 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-07 | 2020-09-14 | 6 | TENDS01 | EC | 10002 | 3 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 4 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 5 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 6 | Electronic Nicotine Delivery SystemP | 1 | CONTAINER | INHALED | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 7 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 8 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-10-15 | 2020-10-22 |
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EX would report the unblinded exposure to nicotine. What should be reported???? We do not really have the real exposue...
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSRGM | EXDOSU | EXROUTE | EXSTDTC | EXENDTC |
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1 | TENDS01 | EX | 10001 | 1 | Electronic Nicotine Delivery System | 0 mg nicotine liquid |
| INHALED | 2020-06-27 | 2020-07-01 | 2 | TENDS01 | EC | 10001 | 2 | Electronic Nicotine Delivery System | 0 mg nicotine liquid | CONTAINER | INHALED | 2020-07-01 | 2020-07-05 | 3 | TENDS01 | EC | 10001 | 3 | Electronic Nicotine Delivery System | 0 mg nicotine liquid | CONTAINER | INHALED | 2020-07-05 | 2020-07-10 | 4 | TENDS01 | EC | 10002 | 1 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid | CONTAINER | INHALED | 2020-09-01 | 2020-09-07 | 5 | TENDS01 | EC | 10002 | 2 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid0 mg nicotine liquid | CONTAINER | INHALED | 2020-09-07 | 2020-09-14 | 6 | TENDS01 | EC | 10002 | 3 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid | CONTAINER | INHALED | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 4 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 5 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 6 | Electronic Nicotine Delivery SystemP | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 7 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 8 | Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-10-15 | 2020-10-22 |
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