Review by Cary Gross – 06/10/2020 – 9:25pm

Data Request Number: 2020-4341 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):

Do these trials rigorously assess for Legionnaires’ disease and Listeriosis? How is disease status ascertained?

Recommendation for this data request: Not Approve

Curious about whether these two rare infectious diseases are assessed using a standardized and rigorous approach across all trials.