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

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 The sponsor used the EC domain to represent the collected exposure data. These usage recommendations were represented in ECDOSRGM, which is the intended Dose Regimen.    The ECMOOD permissible variable was used to reflect the prescribed and the actual usage of the inhaled nicotine. When this variable is used, it must be populated for all records. This variable can not be used in EX.   

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