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The examples in this sub-section illustrate how to represent lists of design parameter specifications and testing for conformance to those specifications using three tobacco product categories: cigarettes (Example 1), ENDS devices (Example 2) and smokeless tobacco products (Example 3). Each example starts with a TO dataset, followed by a product design parameters (PD) dataset and a tobacco product testing (PT) dataset.

Note that tobacco product testing for conformance to design parameters would typically require multiple replicates for each parameter being tested. In SDTM, each replicate would be represented in its own record, differentiated by using the PTREPNUM variable (repetition number), which would be set to values of 1 through n (where n = the total number of replicates being tested.  For simplicity of review, each example does make use of the PTREPNUM variable, but only for one record. In reality, if only one record for a given parameter or analyte is collected, the PTREPNUM variable would not be used.

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