This This is an example of a cross-over crossover study where testing 7 smokeless tobacco products were tested. Subject . All products contain nicotine except for product F, which was a nicotine-/tobacco-free product. 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. . Subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a DA domain, nor an EC domain. The name of the actual product would be used, but a dummy name is used in this example.
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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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
Ec10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC10001 | 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
EC| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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 |
XE| 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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