Review by Nihar Desai – 09/03/2020 – 9:56pm

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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

I understand the rationale here but I do wonder whether the results are actionable…if we find heterogeous effects how can we ultimately apply that clinically? Aren’t we better off by looking at clinically relevant subgroups or other clinical predictors of response (biomarkers, demographics, etc)?

Recommendation for this data request: Approve