Review by Joseph Ross – 09/28/2015 – 5:46pm

Data Request Number: 2015-0592 Please use this space to provide any comments, feedback or concerns (optional):

More information from the investigators on “informative” versus “uninformative” study sites is needed. What are the reasons why some study sites would not have as many patients with a treatment response when compared with others? Is it related to ancillary interventions in the trial (such as Cognitive Behavioral Therapy) or that the drug is less effective? This needs to be better clarified.

Recommendation for this data request: Not Approve

See comments above