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Lines 2-14:Show the "Percent of subjects" operation of the "Summary by group of a categorical variable" analysis method, which has 2 referenced operation relationships, which identify the operations whose results are used as the numerator and denominator in the calculation of the percentage. For both referenced operation relationships in this example, the referencedOperationRole attribute of the ReferencedOperationRelationship class contain class contains a controlledTerm with a permissible value from the OperationRoleEnum enumeration. 
Lines 19-24:

Show that, for the "Comparison of Subjects with TEAEs by Treatment - Placebo vs Low Dose" analysis:

  • Lines 21-22: The reason attribute contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the AnalysisReasonEnum enumerator (as shown in the example in the TerminologyExtension section).
  • Lines 23-24: The purpose attribute contain  attribute contains a controlledTerm with a permissible value from the AnalysisPurposeEnum enumeration.
Lines 27-37:

Show the "Summary of Demographics" output, which has two file specifications and the fileType attribute for:

  • Lines 32-33: The first file specification contains a controlledTerm with a permissible value from the OutputFileTypeEnum enumeration.
  • Lines 36-37: The second file specification contains a sponsorTermId with the identifier value of a sponsor term defined in the terminology extension for the OutputFileTypeEnum enumerator (as shown in the example in the TerminologyExtension section).

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