Review by Nihar Desai – 11/20/2018 – 5:14pm

Data Request Number: 2018-3737 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):

This appears to be a straightforward analysis, I would suspect that sex specific data is available in most of the clinical trials so this would be a meta-analysis across phase 2-4 trials.

Recommendation for this data request: Approve