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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 were provided to the subject at each visit.  At visits 1-3, subjects were to use 6-10 cartridges per day, and during 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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Dataset wrap
NameDA
Rowcaps
Rows 1, 3:  Show the number of cartridges dispensed to the subject.  
Rows 2, 4:Show the number of cartridges returned by the subject. 
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TIN111DATIN701

1

DISPAMTDispensed AmountSTUDY PRODUCT90CARTRIDGE60906090CARTRIDGE12004-06-26
2TIN111DATIN701

2

RETAMTReturned AmountSTUDY PRODUCT13CARTRIDGE24132413CARTRIDGE22020-07-06
3TIN111DATIN701

3

DISPAMTDispensed AmountSTUDY PRODUCT9050CARTRIDGE80508050CARTRIDGE22020-07-06
4TIN111DATIN701

4

RETAMTReturned AmountSTUDY PRODUCT10CARTRIDGE34103410CARTRIDGE32020-07-14

 The sponsor used the EC domain to represent the collected exposure data. The 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 cannot be used in EX.   

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