Volume 132, Issue 1, Pages 76-86 (January 2007) A Randomized, Placebo-Controlled, Phase II Study of Tetomilast in Active Ulcerative Colitis  Stefan Schreiber, Ali Keshavarzian, Kim L. Isaacs, John Schollenberger, Juan P. Guzman, Cesare Orlandi, Stephen B. Hanauer  Gastroenterology  Volume 132, Issue 1, Pages 76-86 (January 2007) DOI: 10.1053/j.gastro.2006.11.029 Copyright © 2007 AGA Institute Terms and Conditions

Figure 1 Mean changes in DAI score (LOCF). Values indicate mean change from baseline in total DAI scores with standard errors of means. An analysis of covariance (including baseline DAI score, treatment group, and concomitant mesalamine use in the model) was used for calculating statistical significance of tetomilast 25 mg and 50 mg vs placebo at weeks 4 and 8 of treatment. Lower total DAI scores indicate less disease activity. Total DAI scores ranged from 0 (no disease) to 12 (severe disease). Gastroenterology 2007 132, 76-86DOI: (10.1053/j.gastro.2006.11.029) Copyright © 2007 AGA Institute Terms and Conditions

Figure 2 Mean changes in DAI subscores for all subjects (observed cases). Values indicate mean change from baseline in DAI subscores with standard errors of means. Significances were calculated using the Cochran–Mantel–Haenzel test. The stool frequency subscore ranged from 0 (normal number of stools) to 3 (5 or more stools than usual); the rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed); the flexible sigmoidoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease, spontaneously bleeding, ulceration); Physician’s Global Index score ranged from 0 (normal) to 3 (severe disease). Gastroenterology 2007 132, 76-86DOI: (10.1053/j.gastro.2006.11.029) Copyright © 2007 AGA Institute Terms and Conditions