Review by Cary Gross – 02/22/2015 – 8:47pm

Data Request Number: 2015-0416 Please use this space to provide any comments, feedback or concerns (optional):

The authors may want to consider testing for an interaction between treatment arm and baseline fracture “risk factors” in their Aim 1 analysis, in order to determine if there are specific characteristics that moderate the risk associated with canagliflozin.

Recommendation for this data request: Approve