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In this study, subjects were randomized to nicotine lozenges or placebo. Subject were allowed to smoke cigarettes. one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS device that used 0, 8 or 36 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product. Each cartridge was 8 mL. No other Nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.

The sponsor reported the cigarettes used in the in the SU domain. The number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, a 0 was recorded. Only a few rows are shown.

Dataset wrap

Dataset2

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC
1	TENDS01	SU	ABC-01001	1	CIGARETTECIGARETTES	TOBACCO	6	CIGARETTE	PER DAY	2020-06-27	2020-06-27
2	TENDS01	SU	ABC-01001	1	CIGARETTECIGARETTES	TOBACCO	1	CIGARETTE	PER DAY	2020-06-28	2020-06-28
3	TENDS01	SU	ABC-01001	1	CIGARETTECIGARETTES	TOBACCO	0	CIGARETTE	PER DAY	2020-06-29	2020-06-29

A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. This unique number was represented in DAREF. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed. Cartridges were replaced at each visit the subject was supplied with 2 bottles of lozenges that contained 40 lozenges each. The number of lozenges returned were counted. . DADTC are the visit dates when the cartridge was returned or dispensed. Cartridges not used were record as having the full volume returned.

Dataset wrap

Dataset2

Row	STUDYID	DOMAIN	USUBJID	DASEQ	DAREFID	DATESTCD	DATEST	DACAT	DAORRES	DAORRESU	DASTRESC	DASTRESN	DASTRESU	DASTAT	DAREASND	VISITNUM	DADTC
1	ABC	DA	ABC-01001	1	CRT8754	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	1mL	8	8	mL	1	2004-06-26
2	ABC	DA	ABC-01001	2	CRT8768	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	1	2004-06-26
3	ABC	DA	ABC-01001	3	CRT8769	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	1	2004-06-26
4	ABC	DA	ABC-01001	4	CRT8754	RETAMT	Returned Amount	STUDY PRODUCT	NOT DONE		2	mL	6	6	mL	2Subject forgot to return the cartridge	2020-07-06
52	ABC	DA	ABC-01001	5	CRT8768	RETAMT	Returned Amount	STUDY PRODUCT	1.6	mL	8	8	mL	2	2020-07-06
63	ABC	DA	ABC-01001	6	CRT8769	RETAMT	Returned Amount	STUDY PRODUCT	8	mL	8	8	mL	2	2020-07-06
75	ABC	DA	ABC-01001	7	CRT9756	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	2	2020-07-06
86	ABC	DA	ABC-01001	8	CRT9756	RETAMT	Returned Amount	STUDY PRODUCT	1.0	mL	1.3	1.3	mL	3	2020-07-10	9	ABC	DA	ABC-01001	4	Returned Amount	STUDY PRODUCT	2	mL	6	6	mL	3	2020-07-06

Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.

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