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This section provides advice and examples for representing data from nonclinical tobacco product research using the Study Data Tabulation Model (SDTM), including:

• guidance Guidance on the use of domains and variables;

• examples Examples of SDTM datasets, with text describing the situational context and pointing out records of note;
• descriptions Descriptions and examples of trial design datasets for use with both in vitro and in vivo studies (TS, TX domains); and
• additional Additional trial design datasets needed to fully describe in vivo study designs (TA, TE domains)

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