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The AnalysisSet class, which is a specialization of the WhereClause class, is used in the analysisSets attribute of the ReportingEvent class to define the analysis sets, or subject populations, that define the sets of subjects whose data are to be included in the main analyses, as defined in the statistical section of the protocol.

Each analysis sets defined for the reporting event. Each analysis set, or subject population, is defined using the “AnalysisSet” class as a set of subjects whose data are to be included in the main analyses. This is as defined in the statistical section of the protocol.set is defined as an instance of the AnalysisSet class, in which:

• The id attribute contains the assigned identifier value for the analysis set.
• The label attribute contains a short description for the analysis set (e.g., "Safety Population").
• The level and order attributes are both assigned a value of "1".
• Either:
  • The condition attribute contains the definition of a simple data selection criterion represented as an instance of the WhereClauseCondition class, as described in the WhereClauseCondition section.

Or:

• • The compoundExpression attribute contains the definition of a compound expression represented as an instance of the CompoundSetExpression class, in which:
    • The logicalOperator attribute contains a value from the ExpressionLogicalOperatorEnum enumeration.
    • The whereClauses attribute contains 1 or more references to other instances of the AnalysisSet class represented as identifier values.

Refer to the WhereClauseCompoundExpression section for more information about compound expressions.