Review by Cary Gross – 05/04/2016 – 6:44pm

Data Request Number: 2016-0698 Please use this space to provide any comments, feedback or concerns (optional):

The investigators state that they will be conducting a summary-level meta-analysis, and are requesting the CSRs. However, their analytic plan calls for analysis of patient-level factors such as severity, pain intensity, and treatment type. It would be helpful to clarify whether they plan to analyze patient-level data.
  It is  unclear which trials are being included in the meta-analysis.

Recommendation for this data request: Not Approve

See above