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| Row 1: | Shows the scheduled usage recommendation for the inhaled nicotine. Note, the details on the scheduled records are described at a different level than the performed records. ECDOSRGM shows that for these start and end dates the subject was recommended to use 6-12 cartridges every day. | | Rows 2, 3: | Show the actual "performed" amount of inhaled nicotine used by the subject each day. Note only a few rows of the performed records are shown. | | Row 4: | Shows the scheduled usage recommendation for the inhaled nicotine. ECDOSRGM shows that for these start and end dates the subject was recommended to use 3-6 cartridges per day.. | | Row 5: | Shows the actual "performed" amount of inhaled nicotine used by the subject each day. Note only a few rows of the performed records are shown. |
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| Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECMOOD | ECDOS | ECDOSU | ECDOSFREQ | ECDOSRGM | ECROUTE | EPOCH | ECSTDTC | ECENDTC |
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| 1 | TIN111 | EC | TIN701 | 1 | INHALED NICOTINE | SCHEDULED |
| CARTRIDGE |
| 6 -10 cartridges per day | RESPIRATORY (INHALATION) | TREATMENTPRODUCT EXPOSURE | 2004-06-26 | 2004-07-06 | | 2 | TIN111 | EC | TIN701 | 2 | INHALED NICOTINE | PERFORMED | 7 | CARTRIDGE | QD |
| IRESPIRATORY (INHALATION) | TREATMENTPRODUCT EXPOSURE | 2004-06-26 | 2004-06-26 | | 3 | TIN111 | EC | TIN701 | 3 | INHALED NICOTINE | PERFORMED | 2 | CARTRIDGE | QD |
| IRESPIRATORY (INHALATION) | TREATMENTPRODUCT EXPOSURE | 2004-06-27 | 2004-06-27 | | 4 | TIN111 | EC | TIN701 | 4 | INHALED NICOTINE | SCHEDULED |
| CARTRIDGE |
| 3-6 cartridges per day | RESPIRATORY (INHALATION) | TREATMENTPRODUCT EXPOSURE | 2004-07-06 | 2004-07-20 | | 5 | TIN111 | EC | TIN701 | 5 | INHALED NICOTINE | PERFORMED | 3 | CARTRIDGE | QD |
| RESPIRATORY (INHALATION) | TREATMENTPRODUCT EXPOSURE | 2004-07-07 | 2004-07-07 |
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The EX dataset shows the actual administrations. Note the scheduled records are not included. Only a few rows are shown for illustration. The pharmaceutical strength was included to identify what dose of the nicotine inhaler was used by the subject. Since EXENDTC is an expected variable, the sponsor populated this timing variable with the start date.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EPOCH | EXSTDTC | EXENDTC |
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| 1 | TIN111 | EX | TIN701 | 1 | INHALED NICOTINE | 7 | CARTRIDGE | RESPIRATORY (INHALATION) | 6 | mgTREATMENT | PRODUCT EXPOSURE | 2004-06-26 | 2004-06-26 | | 2 | TIN111 | EX | TIN701 | 2 | INHALED NICOTINE | 2 | CARTRIDGE | RESPIRATORY (INHALATION) | 6 | mgTREATMENT | PRODUCT EXPOSURE | 2004-06-27 | 2004-06-27 | | 3 | TIN111 | EX | TIN701 | 1 | INHALED NICOTINE | 3 | CARTRIDGE | RESPIRATORY (INHALATION) | 4 | mgTREATMENT | PRODUCT EXPOSURE | 2004-07-07 | 2004-07-07 |
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