Review by Joseph Ross – 07/06/2016 – 12:59pm

Data Request Number: 2016-0969 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, would defer to Data Holder Due Diligence Assessment Please use this space to provide any comments, feedback or concerns (optional):

Key for this proposal is whether pharmacokinetic data are available for trial participants for each of the 4 requested studies, and how often pharmacokinetics were measured. I defer to data holder on this issue, but if these data are available, the proposal is clear and will generate important scientific information.

Recommendation for this data request: Approve