Now I’m a little confused. I was under the same impression as BDAZ that the CSC was blinded but according to Sarah’s reply to Kelsee the CSC does the SSRA so they would have to be unblinded for that.

Personally I just hope this SSRA comes in with no snags and further that we have a successful trial that goes full term. As BDAZ points out this is a short CVOT and for a chronic use application safety over a long term is a requirement.

To me if Don said, without being unblinded, that the trial is properly powered so no worries it would indicate that he doesn’t fully understand the necessity of the SSRA and the ramifications that the various outcomes of the SSRA might bring to bear on this trial. JMO