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The associated SDTM datasets for the data collected above are provided below. An abbreviated  Tobacco Product Identifiers and Descriptors (TO) domain example is provided for reference below.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-121
TO provides a mechanism for uniquely identifying a tobacco product, and is the source of the SPTOBID variable.  For For more information on this domain, see  section see Section 3.1.1, Tobacco Product Identifiers and Descriptors. Only one tobacco product was of interest in the study. 

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The applicant decided to use the International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes. Annex A ( 2022) provides the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element (See Section 2.10, Standards for Data Exchange).

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