In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS device that used 0, 8 or 36 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product. Each cartridge was 8 mL. No other Nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXREFID | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRG | EXSTDTC | EXENDTC |
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1 | TENDS01 | EX | 10001 | 1 | CRT8754 | e- | liquid nicotine liquid | 6 | mL | INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-01 | 2 | TENDS01 | EC | 10001 | 2 | CRT8768 | e- | liquid nicotine liquid | 6.7 | mL | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-06 | 3 | TENDS01 | EC | 10001 | 3 | CRT9756 | e- | liquid nicotine liquid | 7 | mL | INHALED | 8 | mg/mL | 2020-07-06 | 2020-07-10 | 3 | TENDS01 | EC | 10001 | 4 | CRT9778 | e- | liquid nicotine liquid | 8 | mL | INHALED | 8 | mg/mL | 2020-07-10 | 2020-07-14 | 4 | TENDS01 | EC | 10002 | 5liquid nicotine liquid | 5 | mL | INHALED | 3624 | mg/mL | 2020-09-01 | 2020-09-07 | 5 | TENDS01 | EC | 10002 | 6liquid nicotine liquid | 7 | mL | INHALED | 3624 | mg/mL | 2020-09-07 | 2020-09-14 | 6 | TENDS01 | EC | 10002 | 7liquid nicotine liquid | 8 | mL | INHALED | 3624 | mg/mL | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 8liquid nicotine liquid | 6 | mL | INHALED | 3624 | mg/mL | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 9liquid nicotine liquid | 7 | mL | INHALED | 3624 | mg/mL | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 10liquid nicotine liquid | 8 | mL | INHALED | 3624 | mg/mL | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 1liquid nicotine liquid | 6.7 | mL | INHALED | 3624 | mg/mL | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 2liquid nicotine liquid | 5.5 | mL | INHALED | 3624 | mg/mL | 2020-10-15 | 2020-10-22 |
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