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In this study, the weight of the contents in the cartridges were tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of each cartridge. ONly Only a few rows are shown. The produt accountability information was not provided for the nicotine replaement 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 | | CRT8755 | 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 | | CRT9757 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 10 | g | 14 | 143 | g | 2 | 2020-06-08 | | 5 | TEDP07 | DA | 10001 | | CRT8755 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.2 | g | 25 | 25 | g | 2 | 2004-06-09 |
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EC was used to represent the collected exposure data since a double dummy design was used. The ,while the EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor represented each cartridge used. The dose was represented has "1" to indicate only one cartidge wsa used. The actual date and time of usage of the cartridge was recorded precisely on days 1, 5, and 10, while only the date of usage was reccorded on other days.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | ECROUTE | ECFREQ | ECLOC | ECLAT | ECDIR | EPOCH | ECSTDTC | ECENDTC |
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| 1 | TEDP07 | EC | 10001 | 1 | ENDS |
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PUFFTREATMENT01T801T8:| 10 | | 2 | TEDP07 | EC | 10001 | 2 | PATCH | 1 | PATCH | TRANSDERMAL |
| ARM | RIGHT | UPPER |
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TREATMENT| PRODUCT EXPOSURE | 2020-06-01 | 2020-06-02 | | 3 | TEDP07 | EC | 10001 | 3 | ENDS | 1 |
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CONTAINER| CARTRIDGE | INHALED | AD LIBITUM |
TREATMENT01:T12| 01T12:10 | 2020-06-02 | | 4 | TEDP07 | EC | 10001 | 1 | ENDS | 1 |
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CONTAINER| CARTRIDGE | INHALED | AD LIBITUM |
TREATMENT
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| PRODUCT EXPOSURE | 2020-06-02 | 2020-06-02 | | 5 | TEDP07 | EC | 10001 | 1 | PATCH | 1 | PATCH | TRANSDERMAL |
| ARM | LEFT | UPPER |
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TREATMENT| PRODUCT EXPOSURE | 2020-06-02 | 2020-06-03 | | 6 | TEDP07 | EC | 10001 | 2 | ENDS | 1 |
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CONTAINER| CARTRIDGE | INHALED | AD LIBITUM |
TREATMENT
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| PRODUCT EXPOSURE | 2020-06-03 | 2020-06-03 | | 7 | TEDP07 | EC | 10001 | 3 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | LEFT | UPPER |
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TREATMENT| PRODUCT EXPOSURE | 2020-06-03 | 2020-06-04 | | 7 | TEDP07 | EC | 10001 | 4 | ENDS | 1 |
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CONTAINER| CARTRIDGE | INHALED | AD LIBITUM |
TREATMENT
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| PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 | | 8 | TEDP07 | EC | 10001 | 5 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | LEFT | LOWER |
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TREATMENT| PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 | | 9 | TEDP07 | EC | 10001 | 6 | ENDS | 1 |
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CONTAINERTREATMENTT09;8T09;8| 09T8:40 | | 10 | TEDP07 | EC | 10001 | 7 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | RIGHT | LOWER |
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TREATMENT| PRODUCT EXPOSURE | 2020-06-10 | 2020-06-11 | | 11 | TEDP07 | EC | 10001 | 8 | ENDS | 1 |
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CONTAINER| CARTRIDGE | INHALED | AD LIBITUM |
TREATMENT10T12: |
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TIME FORMATS NEED TO BE FIXED
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXFREQ | EXLOC | EXLAT | EXDIR | EPOCH | EXPSTRG | EXPSTRGU | ECSTDTC | ECENDTC |
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| 1 | TEDP07 | EX | 10001 | 1 | e nicotine liquid | 3 | g | INHALED | ONCE |
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| TREATMENT | 5 | % | 2020-06-0101T08:T8:00 | 2020-06-0101T:8:10 |
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| 2 | TEDP07 | EX | 10001 | 2 | e nicotine liquid | 15 | g | INHALED | AD LIBITUM |
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| TRE5ATMENT | 5 | % | 2020-06-0101T08:T8:10 | 2020-06-02 |
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| 3 | TEDP07 | EX | 10001 | 3 | e nicotine liquid | 13 | g | INHALED | AD LIBITUM |
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| TREATMENT | 5 | % | 2020-06-02 | 2020-06-02 |
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| 4 | TEDP07 | EX | 10001 | 4 | e nicotine liquid | 12 | g | INHALED | AD LIBITUM |
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| TREATMENT | 5 | % | 2020-06-03 | 2020-06-03 |
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| 5 | TEDP07 | EX | 10001 | 5 | e nicotine liquid | 9 | g | INHALED | AD LIBITUM |
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| TREATMENT | 5 | % | 2020-06-04 | 2020-06-05 |
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| 6 | TEDP07 | EX | 10001 | 6 | e nicotine liquid | 7 | g | INHALED | ONCE |
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| TREATMENT | 5 | % | 2020-06-09T809T08:30 | 2020-06-09T809T08:40 |
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| 7 | TEDP07 | EX | 10001 | 7 | e nicotine liquid | 5 | mg | INHALED | AD LIBITUM |
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| TREATMENT | 5 | % | 2020-06-10T10T12::24040 | 2020-06-11 |
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| 8 | TEDP07 | EX | 20001 | 1 | nicotine replacement therapy | 1 | PATCH | TRANSDERMAL | QD | ARM | RIGHT | UPPER | TREATMENT | 14 | mg | 2020-06-01 | 2020-06-02 |
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| 9 | TEDP07 | EX | 20001 | 2 | nicotine replacement therapy | 1 | PATCH | TRANSDERMAL | QD | ARM | LEFT | UPPER | TREATMENT | 14 | mg | 2020-06-02 | 2020-06-03 |
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| 10 | TEDP07 | EX | 20001 | 3 | nicotine replacement therapy | 1 | PATCH | TRANSDERMAL | QD | LEG | LEFT | UPPER | TREATMENT | 14 | mg | 2020-06-03 | 2020-06-04 |
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| 11 | TEDP07 | EX | 20001 | 4 | nicotine replacement therapy | 1 | PATCH | TRANSDERMAL | QD | LEG | LEFT | LOWER | TREATMENT | 14 | mg | 2020-06-04 | 2020-06-05 |
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| 12 | TEDP07 | EX | 20001 | 5 | nicotine replacement therapy | 1 | PATCH | TRANSDERMAL | QD | LEG | RIGHT | LOWER | TREATMENT | 14 | mg | 2020-06-10 | 2020-06-11 |
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