Review by [current-user:field-firstname] [current-user:field-lastname] – 09/13/2020 – 1:01pm

Data Request Number: 2020-4409 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?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

In this request, the authors outline a study focused on assessing the effect of canagliflozin vs. placebo on liver related outcomes in patients with T2DM and to identify subgroups that are most likely to benefit from treatment. Could the requestors clarify that the trials that are being requested contain the outcomes of interest for this study? In particular, do both trials have information for the primary and/or secondary outcomes outlined in the data request?

 Recommendation for this data request: Not Approve

In this request, the authors outline a study focused on assessing the effect of canagliflozin vs. placebo on liver related outcomes in patients with T2DM and to identify subgroups that are most likely to benefit from treatment. Could the requestors clarify that the trials that are being requested contain the outcomes of interest for this study? In particular, do both trials have information for the primary and/or secondary outcomes outlined in the data request?