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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC |
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1 | TENDS01 | SU | ABC-01001 | 1 | CIGARETTE | TOBACCO | 6 | CIGARETTE | PER DAY | 2020-06-27 | 2020-06-27 | 2 | TENDS01 | SU | ABC-01001 | 1 | CIGARETTE | TOBACCO | 1 | CIGARETTE | PER DAY | 2020-06-28 | 2020-06-28 | 3 | TENDS01 | SU | ABC-01001 | 1 | CIGARETTE | TOBACCO | 0 | CIGARETTE | PER DAY | 2020-06-29 | 2020-06-29 |
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In this study, lozenges that had a strength of 4mg were usedwere the cartridges were being accounted for. A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. The sponsor used DAREFID that appeared on the label to identify the cartridge. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed. Cartridges were replaced at each visit . DADTC are the visit dates when the cartridge was returned or dispensed. A returned cartridges that was not used was recorded as having the full volume returnedthe subject was supplied with 2 bottles of lozenges that contained 40 lozenges each. The number of lozenges returned were counted.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | DASEQ | DAREFID | DATESTCD | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | DASTAT | DAREASND | VISITNUM | DADTC |
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1 | ABC | DA | ABC-01001 | | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 81 | mL |
| 8 | 8 | mL |
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| 1 | 2004-06-26 | 2 | ABC | DA | ABC-01001 | | CRT8768 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL |
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| 1 | 2004-06-26 | 3 | ABC | DA | ABC-01001 | | CRT8769 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL |
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| 1 | 2004-06-26 | 4 | ABC | DA | ABC-01001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT |
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| NOT DONE | Subject forgot to return the cartridge |
| 2020-07-06 | 5 | ABC | DA | ABC-01001 | | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | 1.6 | mL | 8 | 8 | mL |
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| 2 | 2020-07-06 | 6 | ABC | DA | ABC-01001 | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL |
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| 2 | 2020-07-06 | 7 | ABC | DA | ABC-01001 | | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL |
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| 2 | 2020-07-06 | 8 | ABC | DA | ABC-01001 | | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | 1.0 | mL | 1.3 | 1.3 | mL |
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| 3 | 2020-07-10 | 9 | ABC | DA | ABC-01001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | 2 | mL | 6 | 6 | mL |
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| 3 | 2020-07-06 |
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