Review by Nihar Desai – 05/19/2020 – 7:52pm

Data Request Number: 2019-4132 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 trial the investigators are requesting have subjects. I worry a bit about the statistical power and whether they have adequate sample size to undertake the modeling they propose.

Recommendation for this data request: Not Approve