Product Accountability (DA ) Domain

This example shows information about the dispensing and returning of the study product. In this study, moist tobacco product was dispensed in containers. The number of containers dispensed depended upon the duration between visits, and the amount of smokelsss tobacco used by the subject.  Each container was assigned a identification number.  Each containers was weighted when dispended, and upon return. DASPID is the identification number assigned to each container. For this subject, study product was dispensed at Visit 1, it was returned at Visit 2, where another container was dispensed. This container was returned at Visit 3. No other containers were dispensed to the subject. The sponsor collected the number of times the product was used per day, using a daily diary. This data was represented in the Expose as collect domain (EC)  and is not shown. The sponsor did not submit a EX domain as the estimated actual amount of nicotine used per day was estimated and represented in an ADaM dataset based on the weight of the tobacco used, and the number of times the product was used per/day.