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Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitisDaniel C. Baumgart, MD 1 *, Stephan R. Targan, MD 2, Axel U. Dignass, MD 3, Lloyd Mayer, MD 4, Gert van Assche, MD 5, Daan W. Hommes, MD 6, Stephen B. Hanauer, MD 7, Uma Mahadevan, MD 8, Walter Reinisch, MD 9, Scott E. Plevy, MD 10, Bruce A. Salzberg, MD 11, Alan L. Buchman, MD 12, Grigor M. Mechkov, MD 13, Zahariy A. Krastev, MD 14, James N. Lowder, MD 15, Matthew B. Frankel, MD 15, William J. Sandborn, MD 161Departments of Medicine, Divisions of Gastroenterology and Hepatology, Charité Medical School of the Humboldt-University of Berlin, Germany2Departments of Medicine, Divisions of Gastroenterology and Hepatology, Cedars Sinai Medical Center, University of California, Los Angeles, CA, USA3Departments of Medicine, Divisions of Gastroenterology and Hepatology, Markuskrankenhaus, Frankfurt, Germany4Departments of Medicine, Divisions of Gastroenterology and Hepatology, Mount Sinai School of Medicine, New York, NY, USA5Departments of Medicine, Divisions of Gastroenterology and Hepatology, Universitaire Ziekenhuizen Gasthuisberg, Leuven, Belgium6Departments of Medicine, Divisions of Gastroenterology and Hepatology, University of Leiden, Leiden, The Netherlands7Departments of Medicine, Divisions of Gastroenterology and Hepatology, University of Chicago, Chicago, IL, USA8Departments of Medicine, Divisions of Gastroenterology and Hepatology, University of California San Francisco, CA, USA9Departments of Medicine, Divisions of Gastroenterology and Hepatology, Medizinische Universität Wien, Vienna, Austria10Departments of Medicine, Divisions of Gastroenterology and Hepatology, University of Pittsburgh, Pittsburgh, PA, USA11Departments of Medicine, Divisions of Gastroenterology and Hepatology, Atlanta Gastroenterology Associates, Atlanta, GA, USA12Departments of Medicine, Divisions of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA13Departments of Medicine, Divisions of Gastroenterology and Hepatology, Military Medical Academy, Sofia, Bulgaria14Departments of Medicine, Divisions of Gastroenterology and Hepatology. University of Sofia, Sofia, Bulgaria15Departments of Medicine, Divisions of Gastroenterology and Hepatology, Facet Biotech Corp. (formerly Protein Design Labs and then PDL BioPharma), Redwood City, CA16Departments of Medicine, Divisions of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USAemail: Daniel C. Baumgart (daniel.

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