This is an example of a crossover study testing 7 smokeless tobacco products. All products contain nicotine except for product F, which was a nicotine-/tobacco-free product. Each subject first used the product ad libitum; the next day, the product usage was evaluated in the morning, as specified in the protocol. 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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ECSEQECTRTECCATECDOSEECDOSUECDOSFRQEXROUTEVISITDY ECSTDTCXEENDTCEC10001 AD LIBITUM UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-06-27T13:10:33 | 2019-06-27T13:38:49 | 2 | ALCS-REG-STUDY | EC10001 AD LIBITUM UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-06-28T08:00:12 | 2019-06-28T08:30:21 | 4 | ALCS-REG-STUDY | EC10001 AD LIBITUM UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-06-28T14:01:52 | 2019-06-28T14:55:27 | 5 | ALCS-REG-STUDY | EC10001 AD LIBITUM UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALTREATMENTPRODUCT 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 | ONCEORALmg | 17 | DAY 7/EARLY TERMINATION | 7 | TREATMENTPRODUCT EXPOSURE | 2019-07-04T08:00:04 | 2019-07-04T08:30:05 | 22 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 1 | PRODUCT E | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-04T14:06:09 | 2019-07-04T14:14:14 | 23 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 2 | PRODUCT E | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-05T08:00:00 | 2019-07-05T08:30:00 | 24 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 3 | PRODUCT D | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-05T14:02:39 | 2019-07-05T14:18:57 | 25 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 4 | PRODUCT D | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-06T08:00:00 | 2019-07-06T08:30:00 | 26 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 5 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-06T14:00:00 | 2019-07-06T14:08:40 | 27 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 6 | PRODUCT C | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-06T15:52:53 | 2019-07-06T15:59:21 | 28 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 7 | PRODUCT C | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-07T08:00:00 | 2019-07-07T08:30:00 | 29 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 8 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-07T14:01:12 | 2019-07-07T14:12:25 | 30 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 9 | PRODUCT F | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-07T14:57:49 | 2019-07-07T15:07:07 | 31 | ALCS-REG-STUDY | ECEX | ALCS-REG-STUDY_10002 | 10 | PRODUCT F | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-08T08:00:00 | 2019-07-08T08:30:00 | 32 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 11 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-08T14:00:52 | 2019-07-08T14:17:31 | 33 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 12 | PRODUCT B | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-08T14:46:07 | 2019-07-08T14:53:43 | 34 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 13 | PRODUCT B | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-09T08:00:01 | 2019-07-09T08:30:01 | 35 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 14 | PRODUCT G | UNCONTROLLED PRODUCT USE | 2.69 | g | QUID | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-09T14:06:24 | 2019-07-09T14:30:16 | 36 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 15 | PRODUCT G | UNCONTROLLED PRODUCT USE | 3.3 | g | QUID | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-09T14:49:39 | 2019-07-09T15:15:16 | 37 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 16 | PRODUCT G | CONTROLLED PRODUCT USE | 2 | g | QUID | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-10T08:00:00 | 2019-07-10T08:30:00 | 38 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 17 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-10T14:02:07 | 2019-07-10T14:35:40 | 39 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 18 | PRODUCT A | UNCONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ONCEORALTREATMENTPRODUCT EXPOSURE | 2019-07-10T15:27:37 | 2019-07-10T15:58:24 | 40 | ALCS-REG-STUDY | XEEX | ALCS-REG-STUDY_10002 | 19 | PRODUCT A | CONTROLLED PRODUCT USE | 1 | POUCH | POUCH | ORAL | ONCEORALmg | 17 | DAY 7/EARLY TERMINATION | 7 | TREATMENTPRODUCT EXPOSURE | 2019-07-11T08:00:00 | 2019-07-11T08:30:00 |
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