This This is an example of a cross-over crossover study where testing 7 smokeless tobacco products were tested. All product products contain nicotine except for product F, which was a nicotine-/tobacco-free product. Subject Each subject first used the product ad libitum and then ; the next day, the product usage was evaluated in the morning, as specified in the protocol in the morning. The subjects Subjects were confined to the site. Product Products were supplied to the subject subjects as needed by site staff. Each usage was recorded. The sponsor applicant did not submit a Product Accountability ( DA ) domain, or the nor an EC domain. The name of the actual product was not would be used, but a dummy name is used in the this example below.
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXCAT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | VISITNUM | VISIT |
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VISITDY | VISITDY | EPOCH | EXSTDTC | EXENDTC |
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| 1 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 1 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 10 | DAY -1 | -1 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-27T13:10:33 | 2019-06-27T13:38:49 | | 2 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 2 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 10 | DAY -1 | -1 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-27T14:29:13 | 2019-06-27T14:54:53 | | 3 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 3 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 11 | DAY 1 | 1 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-28T08:00:12 | 2019-06-28T08:30:21 | | 4 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 4 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-28T14:01:52 | 2019-06-28T14:55:27 | | 5 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 5 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-28T15:18:35 | 2019-06-28T15:57:33 | | 6 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 6 | PRODUCT E | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-29T08:00:08 | 2019-06-29T08:30:13 | | 7 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 7 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-29T14:01:50 | 2019-06-29T14:50:11 | | 8 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 8 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-29T15:24:33 | 2019-06-29T15:59:46 | | 9 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 9 | PRODUCT B | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-30T08:00:00 | 2019-06-30T08:30:00 | | 10 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 10 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-30T14:12:32 | 2019-06-30T14:47:47 | | 11 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 11 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-06-30T15:24:46 | 2019-06-30T16:04:57 | | 12 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 12 | PRODUCT D | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-01T08:00:00 | 2019-07-01T08:30:00 | | 13 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 13 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-01T14:02:36 | 2019-07-01T14:47:33 | | 14 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 14 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-01T15:37:45 | 2019-07-01T15:58:15 | | 15 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 15 | PRODUCT A | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-02T08:00:00 | 2019-07-02T08:30:01 | | 16 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 16 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-02T14:11:00 | 2019-07-02T14:54:08 | | 17 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 17 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-02T15:38:52 | 2019-07-02T15:59:50 | | 18 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 18 | PRODUCT F | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-03T08:00:00 | 2019-07-03T08:30:00 | | 19 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 19 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.37 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-03T14:13:14 | 2019-07-03T14:57:40 | | 20 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 20 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.2 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-03T15:35:01 | 2019-07-03T16:07:25 | | 21 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10001 | 21 | PRODUCT G | CONTROLLED PRODUCT USE | 2 | g | QUID | ORAL | 4 | mg | 17 | DAY 7/EARLY TERMINATION | 7 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-04T08:00:04 | 2019-07-04T08:30:05 | | 22 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 1 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 10 | DAY -1 | -1 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-04T14:06:09 | 2019-07-04T14:14:14 | | 23 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 2 | PRODUCT E | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 11 | DAY 1 | 1 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-05T08:00:00 | 2019-07-05T08:30:00 | | 24 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 3 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 11 | DAY 1 | 1 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-05T14:02:39 | 2019-07-05T14:18:57 | | 25 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 4 | PRODUCT D | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 4 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-06T08:00:00 | 2019-07-06T08:30:00 | | 26 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 5 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-06T14:00:00 | 2019-07-06T14:08:40 | | 27 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 6 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 12 | DAY 2 | 2 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-06T15:52:53 | 2019-07-06T15:59:21 | | 28 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 7 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 6 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-07T08:00:00 | 2019-07-07T08:30:00 | | 29 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 8 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-07T14:01:12 | 2019-07-07T14:12:25 | | 30 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 9 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 13 | DAY 3 | 3 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-07T14:57:49 | 2019-07-07T15:07:07 | | 31 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 10 | PRODUCT F | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-08T08:00:00 | 2019-07-08T08:30:00 | | 32 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 11 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 0 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-08T14:00:52 | 2019-07-08T14:17:31 | | 33 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 12 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 14 | DAY 4 | 4 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-08T14:46:07 | 2019-07-08T14:53:43 | | 34 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 13 | PRODUCT B | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 2 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-09T08:00:01 | 2019-07-09T08:30:01 | | 35 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 14 | PRODUCT G | UNCONTROLLED PRODUCT USE | 2.69 | g | QUID | ORAL | 4 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-09T14:06:24 | 2019-07-09T14:30:16 | | 36 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 15 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.3 | g | QUID | ORAL | 4 | mg | 15 | DAY 5 | 5 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-09T14:49:39 | 2019-07-09T15:15:16 | | 37 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 16 | PRODUCT G | CONTROLLED PRODUCT USE | 2 | g | QUID | ORAL | 4 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-10T08:00:00 | 2019-07-10T08:30:00 | | 38 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 17 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-10T14:02:07 | 2019-07-10T14:35:40 | | 39 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 18 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 16 | DAY 6 | 6 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-10T15:27:37 | 2019-07-10T15:58:24 | | 40 | ALCS-REG-STUDY | EX | ALCS-REG-STUDY_10002 | 19 | PRODUCT A | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | 8 | mg | 17 | DAY 7/EARLY TERMINATION | 7 |
TREATMENT| PRODUCT EXPOSURE | 2019-07-11T08:00:00 | 2019-07-11T08:30:00 |
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