Review by Cary Gross – 04/04/2016 – 4:53pm

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

It is unclear whether all patients in these trials were routinely assessed for a history  inflammatory bowel disease or irritable bowel syndrom. As this is one of the main independnet variables, it is worth checking on the availability of these data.