Review by [current-user:field-firstname] [current-user:field-lastname] – 09/04/2020 – 11:53am

Data Request Number: 2020-4390 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 Recommendation for this data request: Not Approve

In this request, the authors aim to apply a novel statistical approach that they developed on two clinical trials. Can the authors outline which outcomes, from the two trials that were identified, will be selected? Are the main outcomes from both trials appropriate for the analyses (i.e, are they continuous)? Once this is clarified, there is enough information to approve the request.