Review by Nihar Desai – 05/14/2016 – 3:09pm

Data Request Number: 2016-0912 Please use this space to provide any comments, feedback or concerns (optional):

I don’t quite understand the 2nd aim.  With regard to the first aim, the primary endpoint of the study seems to be an arrhythmia related endpoint, I am not sure whether survival was part of the primary analysis.  The goal of this analysis (replication of this trial) is important and the authors should specify that their approach will be to replicate the primary analysis of the trial.

Recommendation for this data request: Approve