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Efficacy Data
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Can we present non-significant (N/S) efficacy data in an APS that is included in the Product Monograph (Part II: Clinical trials section)? Does it matter if it’s a primary, secondary or exploratory endpoint? If we can present N/S efficacy data, what parameters are required in order to present these in an APS?
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Can we present non-significant (N/S) efficacy data in an APS that is included in the Product Monograph (Part II: Clinical trials section)? Does it matter if it’s a primary, secondary or exploratory endpoint? If we can present N/S efficacy data, what parameters are required in order to present these in an APS?
