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A Product Accountability domain was submitted to represent dispensed and returned amounts. Each The ENDS product used in the study was assigned a Sponsor Tobacco Product Identifier (VAPE-Z27) and each cartridge had a uniquely assigned number. This unique number was represented in DAREFID. 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. Cartridges not used were record as having the full volume returned.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | DASEQ | SPTOBID | DAREFID | DATESTCD | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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| 1 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 2 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8768 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 3 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8769 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 4 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | 2 | mL | 6 | 6 | mL | 2 | 2020-07-06 | | 2 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | 1.6 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 3 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 5 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 6 | ABC | DA | ABC-01001 | | VAPE-Z27 | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | 1.0 | mL | 1.3 | 1.3 | mL | 3 | 2020-07-10 |
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The domain represented the number of cartridges used (in this example always 1 since each cartridge was tracked), the total amount amount of liquid product used was determined from the DA domain and the associated nicotine pharmaceutical strength of each cartridge was known. The sponsored used this information in the analysis. The summaries included in the analysis analysis were the estimated number of cartridges used per week, and the estimated nicotine exposure from the cartridges per day.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXREFID | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX | 10001 | 1 | VAPE-Z27 | CRT8754 | e-nicotine liquid | 6 | mL | INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-01 | | 2 | TENDS01 | EX | 10001 | 2 | VAPE-Z27 | CRT8768 | e-nicotine liquid | 6.7 | mL | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-06 | | 3 | TENDS01 | EX | 10001 | 3 | VAPE-Z27 | CRT9756 | e-nicotine liquid | 7 | mL | INHALED | 8 | mg/mL | 2020-07-06 | 2020-07-10 | | 3 | TENDS01 | EX | 10001 | 4 | VAPE-Z27 | CRT9778 | e-nicotine liquid | 8 | mL | INHALED | 8 | mg/mL | 2020-07-10 | 2020-07-14 | | 4 | TENDS01 | EX | 10002 | 1 | VAPE-Z27 | CRT8000 | e-nicotine liquid | 5 | mL | INHALED | 24 | mg/mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EX | 10002 | 2 | VAPE-Z27 | CRT9006 | e-nicotine liquid | 7 | mL | INHALED | 24 | mg/mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EX | 10002 | 3 | VAPE-Z27 | CRT9008 | e-nicotine liquid | 8 | mL | INHALED | 24 | mg/mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EX | 10002 | 4 | VAPE-Z27 | CRT9017 | e-nicotine liquid | 6 | mL | INHALED | 24 | mg/mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EX | 10002 | 5 | VAPE-Z27 | CRT9089 | e-nicotine liquid | 7 | mL | INHALED | 24 | mg/mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EX | 10002 | 6 | VAPE-Z27 | CRT9128 | e-nicotine liquid | 8 | mL | INHALED | 24 | mg/mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EX | 10002 | 7 | VAPE-Z27 | CRT6868 | e-nicotine liquid | 6.7 | mL | INHALED | 24 | mg/mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EX | 10002 | 8 | VAPE-Z27 | CRT7868 | e-nicotine liquid | 5.5 | mL | INHALED | 24 | mg/mL | 2020-10-15 | 2020-10-22 |
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