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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 and ; the next day, the product usage was evaluated in the morning, as specified in the protocol. The subjects 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 Product Accountability ( DA ) domain, nor an EC domain. The name of the "the actual product " would be used, but a dummy name was is used in the this example below.

Dataset wrap

Name	Ex

Dataset2

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXCAT	EXDOSE	EXDOSU	EXDOSFRM	EXROUTE	EXPSTRG	EXPSTRGU	VISITNUM	VISIT	VISITDY	EPOCH	EXSTDTC	EXENDTC
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	PRODUCT EXPOSURE	2019-07-11T08:00:00	2019-07-11T08:30:00

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