Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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. 

ECDOSUECDOSFRMECDOSFRQECROUTEECLOCECLATECDIREPOCHECSTDTC
PATCHPATCHQDTRANSDERMALARMRIGHTUPPERTREATMENT2011-01-14
PATCHPATCHQDTRANSDERMALARMLEFTUPPERTREATMENT2011-01-15
PATCHPATCHQDTRANSDERMALARMLEFTUPPERTREATMENT2011-01-24
PATCHPATCHQDTRANSDERMALARM RIGHTINNERTREATMENT2011-01-25
Dataset wrap
Nameec
Dataset2

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSU

ECROUTE

ECVAMT

ECVAMT

ECLOCECLATECDIREPOCH


ECSTDTC

ECENDTC

1TENDS01EC10001 1ENDS  1CONTAINERINHALED36    36




2020-06-272020-07-01
2TENDS01EC10001 2

 PATCH 

1PATCHINHALED

ARMRIGHTUPPER

2020-07-012020-07-05
3TENDS01EC10001 3ENDS 5CONTAINERINHALED8mL




2020-07-052020-07-10
4TENDS01EC100021 PATCH 7PATCHINHALED8mL




2020-09-012020-09-07
5TENDS01EC10002 2ENDS 1CONTAINERINHALED8mL




2020-09-072020-09-14
6TENDS01EC10002 3 PATCH 1PATCHINHALED8mL




2020-09-142020-09-21
7TENDS01EC10002 4ENDS 1CONTAINERINHALED8mL




2020-09-212020-09-28
8TENDS01EC10002 5 PATCH 1PATCHINHALED8mL




2020-09-282020-09-31
9TENDS01EC10002 6ENDS 1CONTAINERINHALED8mL




2020-10-312020-10-08
10TENDS01EC10002 7 PATCH 1PATCH INHALED8mL




2020-10-082020-10-15
11TENDS01EC10002 8ENDS 1CONTAINERINHALED8mL




2020-10-15

2020-10-22







 PATCH 













Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSU

ECROUTE

ECVAMT

ECVAMT

ECSTDTC

ECENDTC

1TENDS01EC10001 1e-nicotine liquid 1CONTAINERINHALED8mL2020-06-272020-07-01
2TENDS01EC10001 2

e-nicotine liquid 

1CONTAINERINHALED8mL2020-07-012020-07-05
3TENDS01EC10001 3e-nicotine liquid  1CONTAINERINHALED8mL2020-07-052020-07-10
4TENDS01EC100021e-nicotine liquid 1CONTAINERINHALED8mL2020-09-012020-09-07
5TENDS01EC10002 2e-nicotine liquid 1CONTAINERINHALED8mL2020-09-072020-09-14
6TENDS01EC10002 3e-nicotine liquid 1CONTAINERINHALED8mL2020-09-142020-09-21
7TENDS01EC10002 4e-nicotine liquid 1CONTAINERINHALED8mL2020-09-212020-09-28
8TENDS01EC10002 5e-nicotine liquid 1CONTAINERINHALED8mL2020-09-282020-09-31
9TENDS01EC10002 6e-nicotine liquid 1CONTAINERINHALED8mL2020-10-312020-10-08
10TENDS01EC10002 7e-nicotine liquid 1CONTAINERINHALED8mL2020-10-082020-10-15
11TENDS01EC10002 8e-nicotine liquid 1CONTAINERINHALED8mL2020-10-15

2020-10-22