Review by Nihar Desai – 06/11/2016 – 1:17pm

Data Request Number: 2016-0979 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?: No If no, please explain:

With 1100 patients in the study I doubt very seriously the authors can meaningfully identify independent predictors of progression (which only a subset of these patients will have).  I would respectfully ask the requestors to include more specifics on rates of progression and how many variables they intend to include in identifying predictors.

Recommendation for this data request: Not Approve

See above.