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Four patients in the study had protocol-defined clinical responses, determined by the Ulcerative Colitis Disease Activity Index (UCDAI) which scores the frequency and the amount of bloody stool per day that is recorded in a patient diary, physician global assessment and the assessment of colon mucosal inflammation ascertained by endoscopy.
Mark's Index and the Ulcerative Colitis Disease Activity Index (UCDAI), and the noninvasive indices were the Simple Clinical Colitis Activity Index (SCCAI) and the Seo index.
The primary endpoint was induction of clinical and endoscopic remission, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) score of 1 after eight weeks, with scores of 0 for rectal bleeding and stool frequency, no mucosal friability after colonoscopy, and 1 point reduction from baseline in the endoscopic index score.