In this study, subjects were randomized to an double blind study were subject were randomized to either nicotine replacement patches or ENDsENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devicedevices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every Day day for 14 15 days, . The nicotine patch was applied at the site every day , at rotating sites, . and the ENDS nicotine cartridge was replaced every day. The cartridge was weight weighed when dispended dispensed and upon return. On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4-hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.
The SU domain was used to represent the number of cigarettes used, but is not shown.
In this study, the weight of the contents in the cartridge was tracked. The DA domain EC was used to represent the collected exposure data.
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dispensed and returned weights of each cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | DASEQ | DAREFID | DATESTCD | DATEST | DACAT | DASCAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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1 | TEDP07 | DA | 10001 | | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.3 | g | 25 | 25 | g | 1 | 2004-06-06 | 2 | TEDP07 | DA | 10001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 23 | g | 23 | 23 | g | 1 | 2020-06-06 | 3 | TEDP07 | DA | 10001 | | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.1 | g | 25 | 25 | g | 1 | 2020-06-07 | 4 | TEDP07 | DA | 10001 | | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 10 | g | 14 | 14 | g | 2 | 2020-06-08 | 5 | TEDP07 | DA | 10001 | | CRT9955 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.2 | g | 25 | 25 | g | 2 | 2004-06-08 |
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EC was used to represent the collected exposure data since a double-blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSTXT | ECDOSU | ECDOSFRM | ECROUTE |
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ECVAMT | ECVAMT | ECLOC | ECLAT | ECDIR | EPOCH | ECSTDTC | ECENDTC |
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1 |
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TENDS011CONTAINERINHALED | 36 | 36CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06- | 270701TENDS01TEDP07 | EC | 10001 | 2 | PATCH | 1 |
| PATCH | PATCH | INHALEDTRANSDERMAL | ARM | RIGHT | UPPER | PRODUCT EXPOSURE | 2020- | 070705TENDS015CONTAINERINHALED | 8 | mLCARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020- | 07050710TENDS01100021 PATCH 7PATCHINHALED | 8 | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | mL09010907TENDS0110002 2ENDS CONTAINER | INHALED | 8 | |
| PATCH | PATCH | TRANSDERMAL | ARM | LEFT | UPPER | PRODUCT EXPOSURE | mL090709-146 | TENDS01 | EC | 10002 | 3 | PATCH | 1 | PATCH | INHALED | 8 | mL | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 4 | ENDS | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 5 | PATCH | 1 | PATCH | INHALED | 8 | mL | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 6 | ENDS | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 7 | PATCH | 1 | PATCH | INHALED | 8 | mL | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 8 | ENDS | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-15 | 2020-10-22 PATCH 06-03 | 6 | TEDP07 | EC | 10001 | 6 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-03 | 2020-06-04 |
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7 | TEDP07 | EC | 10001 | 7 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | LEFT | UPPER | PRODUCT EXPOSURE | 2020-06-03 | 2020-06-04 |
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7 | TEDP07 | EC | 10001 | 8 | ENDS |
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| PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 |
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8 | TEDP07 | EC | 10001 | 9 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | LEFT | LOWER | PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 |
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9 | TEDP07 | EC | 10001 | 10 | ENDS | 10 |
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| PRODUCT EXPOSURE | 2020-06-10T8:30 | 2020-06-10T8:40 |
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10 | TEDP07 | EC | 10001 | 11 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | RIGHT | LOWER | PRODUCT EXPOSURE | 2020-06-10 | 2020-06-11 |
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11 | TEDP07 | EC | 10001 | 12 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-10T12:40 | 2020-06-11 |
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Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.
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ECSEQ
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ECTRT
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ECDOSE
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ECDOSU
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ECROUTE
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ECVAMT
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ECVAMT
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ECSTDTC
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ECENDTC
| EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXLOC | EXLAT | EXDIR | EPOCH | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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1 | TEDP07 | EX |
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.7 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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g | CARTRIDGE | RESPIRATORY (INHALATION) |
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liquid | 13 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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12 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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g | CARTRIDGE | RESPIRATORY (INHALATION) |
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CARTRIDGE | RESPIRATORY (INHALATION) |
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g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PATCH | PATCH | TRANSDERMAL | ARM | RIGHT | UPPER | PRODUCT EXPOSURE | 14 | mg |
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| PATCH | PATCH | TRANSDERMAL | ARM | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg |
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PATCH | PATCH | TRANSDERMAL | LEG | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg |
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| TEDP07 | EX | 20001 | 4 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | LEFT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-04 | 2020-06-05 |
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12 | TEDP07 | EX | 20001 | 5 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | RIGHT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-10 | 2020-06-11 |
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