Review by Joseph Ross – 08/10/2015 – 10:04am

Data Request Number: 2015-0565 Please use this space to provide any comments, feedback or concerns (optional):

I noted that the proposed research could be addressed using the requested data, but I am not sure if that is true. It is not clear to me if there is sufficient information in the data on patients who were screen eligible but not enrolled. My assumption is that the IPD only contains observations on enrolled patients. We will need to ask J&J, as part of the DDA, whether this information is available within the data source. I can then modify my responses marked N/A.