Review by Nihar Desai – 09/02/2016 – 3:59pm

Data Request Number: 2016-0995 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

The enrollment in the trial is 400 patients, the authors propose 16 different endpoints which they want to correlate with long term outcomes.  I am concerned about the power.

 Recommendation for this data request: Approve