Review by Richard Lehman – 10/27/2019 – 2:01pm

Data Request Number: 2019-4001 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 would not wish to stand in the way of the data being made available to the researchers but I am unclear why they with to use such a complex control strategy: “there may be as many as three sources of controls, prospective concurrent controls, retrospective controls, and historical controls or LimiFlex subjects.” 
Earlier they state that “This is a multi-center, prospective, concurrently controlled, non-blinded study. Balance between groups will be achieved through sub classification using propensity scores.”  A standard form of randomized allocation would be  preferable in my view. 

Recommendation for this data request: Approve