Review by Joseph Ross – 05/26/2016 – 8:16am

Data Request Number: 2016-0912 Please use this space to provide any comments, feedback or concerns (optional):

This is an excellent proposal and an important study. Investigators may consider providing additional background on the other cardiovascular trials on which they are testing the replication of results, if there are others. Similarly, the investigators plan to replicate the results of the trial by explicitly following the methods laid out within the text of the article, as well as any online supplements. However, a secondary aim might be to consider replicating the results by explicitly following the methods laid out in the Statistical Analysis Plan, which contains more detail than the manuscript text, and to compare the results to the Clinical Study Report (or CSR summary), which will contain more granular findings, particularly for safety endpoints and adverse events.

Recommendation for this data request: Approve