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Jupe, 

I forgot to answer your first question "does a reporting a successful topline in a CVOT trial mean that the parameter specified as the primary endpoint was signficantly different (in a specified one-way test) in the treatment and control groups (except when non-inferiority is the the primary endpoint)?"

Yes, successful top-line means significant difference between treatment group and control group for the primary outcome. 

BearDownAZ

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