Page History

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

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

The recommended usage instruction for the lozenge were provided to the subject at each visit. At visit 1-3 subjects were to use 6 -10 cartridges per day, and during visit 4-6 subjects were to use 3-6 cartridges per day.  The sponsor used the EC domain to represent the collected exposure data. These usage recommendations were represented in DOSRGM, which is the intended Dose Regimen.    

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The EX dataset shows the actual administrations. Note the scheduled records are not included. Only a few rows are shown for illustration. The pharmaceutical strength was included to identify what dose of the nicotine inhaler was used by the subject.  Since EXENDTC is an expected variable, the sponsor populated this timing variable with the start date.