Review by Harlan Krumholz – 02/16/2016 – 9:58pm

Data Request Number: 2016-0734 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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

To be honest, in these proposals I have trouble determining how what they want to do intersects with what was done by the original trialists. And whether they have the sample size (different issue) to address their objectives.

Recommendation for this data request: Approve