Review by Cary Gross – 12/04/2020 – 1:16pm

Data Request Number: 2020-4529 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):

While this does not affect my recommendation to approve the project, I did find the background section difficult to follow. Since the main objective here is the relation between initial changes in ER (ulcer size) and long-term outcome, would de-emphasize the focus on PROs in the text of the background. That is, the reader will assume this project is focused on PROs, while that is not really the case.

Recommendation for this data request: Approve