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Wednesday, April 01, 2015 1:36:14 PM
"...cover the protocol, changes to the protocol mid-trial, and rationale for the changes as a summary without breaching guidelines for outcomes and preliminary data for trials in progress. The presentation itself would then be able to include some early data supporting the reasoning for the protocol changes and the outcomes regarding those changes. This could all be done without presenting preliminary data for primary and secondary outcomes." Also, as mentioned in my reply response to TOB, generalities about correlations, but without getting into hard data of preliminary findings.
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