Review by Richard Lehman – 02/08/2018 – 3:32pm

Data Request Number: 2018-2761 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:

This a pure guess on my part, given that requests for radiographic data have been ruled out in the past.
However I am not aware of the full background of this request and if J&J have already provided some imaging data, they may be willing to consider providing the de-identified MRI scans which appear to be needed for this analysis.

Please use this space to provide any comments, feedback or concerns (optional):

Needs further clarification from J&J

Recommendation for this data request: Not Approve

see above