Review by Joseph Ross – 05/19/2016 – 1:31pm

Data Request Number: 2016-0919 Recommendation for this data request: Not Approve

This is an excellent proposal and an important study. Prior to initiating the work, we think the investigators should more clearly pre-specify the extra-intenstinal manifestations that will be studied. There are many that could potentially be included, such as those of the musculoskeletal and dermatologic systems, as well as of the hepat-biliary, ocular, renal, and pulmonary systems. Pre-specifying these outcomes will also be of use in case not all endpoints of interest were systematically collected within the 11 requested trials.