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Two new variables, restricted in use to the Tobacco Implementation GuideTIG, have been added to the following sections:

• Section 3.1.4, Identifiers for All Classes
  • GNTXAID
  • SPTOBID

The existing variable , SETCD , was also added to the Section 3.1.3, The Findings Observation Class.

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A number of changes had been proposed during development of the prior version of SDTM , version (Version 2.0).   These same changes remain proposed for the next version of the SDTM. See Section 8, Proposed Future Changes to the SDTM, for the rationale for those proposed future changes.

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