Ulcerative proctitis affects a smaller, more easil

Ulcerative proctitis affects a smaller, more easily accessible area so it seems very smart to use that for proof of concept. I assume that proctoscopy would be needed during the course of the trial to gauge safety and (hopefully) efficacy. People are going to have to be pretty motivated to be in a clinical trial for this application if that kind of evidence is needed, rather than just patients' reports of their symptoms or alleviation of symptoms. Biodoc, what do you think -- is anecdotal evidence enough, or would the study be likely to require several procedures? Is it possible that they could have a subset of patients who have the procedures, and use anecdotal reports for most of the patients?