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TO BE REMOVED ; ISSUES TO BE DISCUSSED  

1: Should  we use SC for all details question about usage and quitting. or FASU....    (e.g.  longest period of abstinence in the past year, Have you attempted to quit smoking, Number of previous attempts to quit smoking, Used patches) , Years of regular smokeless tobacco. (A type of tobacco that is not smoked or burned.) It may be used as chewing tobacco or moist snuff, or inhaled through the nose as dry snuff.)     

2. 4, Is DOSFRM used to identify  Chewing tobacco, snuff, etc. Is this then nicotine as the TRT and the route is ORAL  SNUFF is inhalation.   

INFORMATION ABOUT AGE Started smoking, AVERAGE CIGATEERS USED PER DAY,  USED SMKELESS TOBACCO, E-Cigartees etc. 

Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping    Collected with Check all that appy in CDASH. 

The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product  coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).

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In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.   

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