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  • documentRefs: refer to the DocumentReference section examples of informational document references specified for an output.
  • categoryIds: refer to the AnalysisOutputCategorization section for examples of the categorization of outputs.
  • referencedAnalysisOperations: refer to the Operation section for an example of the definition and use of referenced operation relationships.
  • programmingCode: refer to the AnalysisOutputProgrammingCode section for examples of the representation of programming code for analyses and outputs.
  • results: refer to the OperationResult section for examples of the representation of analysis results.

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Lines 2-30:

Show the definition of the "Comparison of Height by Treatment" analysis, in which:

  • Lines 7-8: Show that the rationale for the performing the analysis was that it was specified in the SAP.
  • Lines 9-10: Show that the purpose of the analysis was that it was a primary outcome measure.
  • Lines 15-16: Show that the analysis variable was the HEIGHTBL variable in the ADSL dataset.
  • Line 17: Shows that the analysis was performed for the analysis set identified as "AnalysisSet_02_SAF" ("Safety Population").
  • Lines 20-23: Show that a single grouping factor identified as "AnlsGrouping_01_Trt" ("Treatment") was referenced in the analysis and results were not expected to be generated for each of the groups in the grouping factor (resultsByGroup = false on line 22).
  • Line 24: Shows the analysis method used for the analysis is identified as "Mth04_ContVar_Comp_Anova" ("ANOVA group comparison for continuous variable").
Lines 31-62:

Show the definition of the "Comparison of Height by Treatment" analysis, in which:

  • Lines 36-37: Show that the rationale for the performing the analysis was that it was specified in the SAP.
  • Lines 38-39: Show that the purpose of the analysis was that it was a primary outcome measure.
  • Lines 44-45: Show that the analysis variable was the AVAL variable in the ADVS dataset.
  • Line 46: Shows that the analysis was performed for the analysis set identified as "AnalysisSet_02_SAF" ("Safety Population").
  • Line 47: Shows that the data subset identified as "Dss09_VS_AnRec" ("Vital Signs Analysis Records") was used to restrict the data records that were included in the analysis.
  • Lines 48-47: Show that 3 grouping factors were referenced in the analysis and results were expected to be generated for each of the groups in all 3 of the the grouping factors (resultsByGroup = true on lines 50, 53, and 36). The 3 grouping factors were identified as:
    • "AnlsGrouping_01_Trt" ("Treatment")
    • "AnlsGrouping_08_Param" ("Parameter")
    • "AnlsGrouping_09_Visit" ("Visit")
  • Line 24: Shows the analysis method used for the analysis is identified as "Mth02_ContVar_Summ_ByGrp" ("Summary by group of a continuous variable").

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