Review by Nihar Desai – 11/16/2017 – 2:44pm

Data Request Number: No Data Request Assigned 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 study is looking at a number of primary and secondary endpoints across 4 subgroups (based on antibody status). How will the authors control for multiplicity of testing and assure adequate power given the dataset they are requesting.

Recommendation for this data request: Not Approve