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In this study, subjects were randomized to different flavors doses of a nicotine lozengesinhaler. The recommended usage instruction instructions for the lozenge nicotine inhaler were provided to the subject at each visit. At visit visits 1-3, subjects were to use 1 lozenges 6-10 cartridges per day every 2 hours, and during visit visits 4-6 subjects were to use 1 lozenge every 4- 8 hours.  Subject were encouraged to 3-6 cartridges per day. Subjects were encouraged not to use any other tobacco products, nicotine replacement therapies  therapies, or alcohol during the study. Data on usage of these products were collected using an e-diary, where the subject subjects provided information on the product products used each day.   Only days were where a product was used  used were represented. 

Alcohol usage and tobacco product usage were represented in the Substance Use (SU) domain.  SUCAT allows the records to be grouped into tobacco-related data and alcohol-related data.   In this example, the products were prespecified so SUTRT does not require a standardized SUDECOD equivalent. The sponsor applicant only include includes SUSTDTC and SUENDTC as timing variables.   

Drugs used in to treat nicotine dependency are  considered  medically acceptable are considered drugs and were represented in the Concomitant Medication (CM) domain. This subject used a 14 mg nicotine replacement patch. The sponsor applicant included the CMCLACMCLASS, CMDECOD, and CM MODIFYCMMODIFY. These were included to reflect standardized coding of the medication.  

A The Product Accountability (DA) domain was used to record represent the amount of study product transferred to or from the study subjects. At each visit the , each subject was supplied with 2 bottles of lozenges that contained 40 lozenges each,  90 cartridges per week for weeks 1-3, and 50 cartridges per week for weeks 4-6. The number of lozenges  cartridges returned were counted. DACAT was used to indicate that the products product of interest was the study product.  DDASPID and DAREFID can be used for code numbers that appeared on the study product label, ; in this case, no code numbers were used included on the labels. The sponsor applicant included VISITNUM and DADTC as these variables are expected in this domain. DADTC was the date the supplies were dispensed or  or returned, these corresponded to the dates of the visits.