...Cox analysis different than the analysis actually conducted may have been mentioned in the 9902a protocol.
The Cox analysis pre-specified in the 9902a (and 9901) protocol was comprised of a Cox analysis referencing a list of prespecified factors known to be related to prognosis. The 9902a Cox analysis was done with factors from that list.
How would you have made the specification different to meet your definition of "fully pre-specified". Or does this specification meet your definition.
I'm not attempting to argue here, just trying to understand this particular point of view.
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