Review by Harlan Krumholz – 04/22/2016 – 9:37pm

Data Request Number: 2016-0884 Please use this space to provide any comments, feedback or concerns (optional):

I don’t quite understand how they are doing individual patient level data analysis when the data have to stay in SAS – and much of the data is from outside of JNJ’s group.

Recommendation for this data request: Approve