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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 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. an double blind study were subject were randomized to either nicotine replacement patches or ENDs. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS device. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every Day for 14 days, The nicotine patch was applied at the site every day at rotating sites,.and the ENDS cartridge was replaced. The cartridge was weight when dispended and upon return.
EC was used to represent the collected exposure data.
ECDOSU | ECDOSFRM | ECDOSFRQ | ECROUTE | ECLOC | ECLAT | ECDIR | EPOCH | ECSTDTC |
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PATCH | PATCH | QD | TRANSDERMAL | ARM | RIGHT | UPPER | TREATMENT | 2011-01-14 |
PATCH | PATCH | QD | TRANSDERMAL | ARM | LEFT | UPPER | TREATMENT | 2011-01-15 |
PATCH | PATCH | QD | TRANSDERMAL | ARM | LEFT | UPPER | TREATMENT | 2011-01-24 |
PATCH | PATCH | QD | TRANSDERMAL | ARM | RIGHT | INNER | TREATMENT | 2011-01-25 |
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | ECROUTE | ECVAMT | ECVAMT | ECSTDTC | ECENDTC |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | TENDS01 | EC | 10001 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-06-27 | 2020-07-01 |
2 | TENDS01 | EC | 10001 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-01 | 2020-07-05 |
3 | TENDS01 | EC | 10001 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-05 | 2020-07-10 |
4 | TENDS01 | EC | 10002 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-01 | 2020-09-07 |
5 | TENDS01 | EC | 10002 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-07 | 2020-09-14 |
6 | TENDS01 | EC | 10002 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-14 | 2020-09-21 |
7 | TENDS01 | EC | 10002 | 4 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-21 | 2020-09-28 |
8 | TENDS01 | EC | 10002 | 5 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-28 | 2020-09-31 |
9 | TENDS01 | EC | 10002 | 6 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-31 | 2020-10-08 |
10 | TENDS01 | EC | 10002 | 7 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-08 | 2020-10-15 |
11 | TENDS01 | EC | 10002 | 8 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-15 | 2020-10-22 |