Page History

...

Studies may be performed under controlled circumstances in clinics.   In these studies, subject may use the study tobacco product of interest ad-librium, or as specified in the protocol.  

...

The domains needed to represent the exposure in a tobacco product study is decided by the sponsor. Some sponsor use the EC domain to reflect the collected exposure data, and then derive EX. The degree of summarization of records from EC to EX is sponsor-defined and is used to support study purpose and analysis.  EX derivations must be described in the Define-XML document. More detail summarization may also be performed in ADaM. For example, the estimated daily nicotine exposure may based on self-reported nicotine exposure may be provided. Since, these are estimates, they are typically not reported in EX.     

...