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Note
  • As in the first pt.xpt dataset, th the details of the smoking machine and smoking regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.
  • Details of the three conditions are represented in the ES dataset example that follows below.

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