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ADaM Review Case Studies - ADSL and BDS design review
Question 1 of 12


You are reviewing ADSL before delivery. The SAP says:

The submitted ADSL contains the flags, but the define.xml derivation column is blank:

VariableSubmitted ValuesUsed ForDefine.xml Derivation
SAFFLY / blankSafety summariesblank
ITTFLY / blankPrimary efficacy populationblank

Which review comment is most appropriate?





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