Review by Richard Lehman – 03/28/2016 – 2:10pm

Data Request Number: 2016-0766 Please use this space to provide any comments, feedback or concerns (optional):

I am not sure if the data set will include sufficient levels of detail about GI symptoms to answer this question. For example, constipation may be reported but probably not in enough detail to assess by the Rome criteria. I’m also surprised that the investigators intend to exclude celiac disease which they mention in their Background section, since although it is auto-immune, it can be made manifest by external factors including medication.

Recommendation for this data request: Approve