Volume 155, Issue 6, Pages e3 (December 2018)

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Volume 155, Issue 6, Pages 1795-1804.e3 (December 2018) Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis Stephan Miehlke, Daniela Aust, Emese Mihaly, Peter Armerding, Günther Böhm, Ole Bonderup, Fernando Fernández-Bañares, Juozas Kupcinskas, Lars Kristian Munck, Kai-Uwe Rehbehn, Tanju Nacak, Roland Greinwald, Andreas Münch Jiri Stehlk, Ole Bonderup, Lars Kristian Munck, Terje Rannem, Peter Armerding, Michael Bläker, Günter Böhm, Mark Hoesl, Christian Kirsch, Ahmed Madisch, Eberhard Meier, Stephan Miehlke, Kai-Uwe Rehbehn, Gyula G. Kiss, Ferenc Nagy, Zsolt Tulassay, Ferenc Zsigmond, Limas Kupcinskas, Gerd Bouma, Marieke Pierik, Fernando Fernández-Bañares, Alfredo J. Lucendo, Johan Bohr, Per Hellström, Barbro Lebrun, Greger Lindberg, Andreas Münch, Lina Vigren, Miroslav Wielondek, Martin Krauss, Axel Dignass, Wolfgang Kruis Stephan Miehlke, Daniela Aust, Emese Mihaly, Peter Armerding, Günther Böhm, Ole Bonderup, Fernando Fernández-Bañares, Juozas Kupcinskas, Lars Kristian Munck, Kai- Uwe Rehbehn, Tanju Nacak, Roland Greinwald, Andreas Münch Jiri Stehlk, Ole Bonderup, Lars Kristian Munck, Terje Rannem, Peter Armerding, Michael Bläker, Günter Böhm, Mark Hoesl, Christian Kirsch, Ahmed Madisch, Eberhard Meier, Stephan Miehlke, Kai-Uwe Rehbehn, Gyula G. Kiss, Ferenc Nagy, Zsolt Tulassay, Ferenc Zsigmond, Limas Kupcinskas, Gerd Bouma, Marieke Pierik, Fernando Fernández-Bañares, Alfredo J. Lucendo, Johan Bohr, Per Hellström, Barbro Lebrun, Greger Lindberg, Andreas Münch, Lina Vigren, Miroslav Wielondek, Martin Krauss, Axel Dignass, Wolfgang Kruis Gastroenterology Volume 155, Issue 6, Pages 1795-1804.e3 (December 2018) DOI: 10.1053/j.gastro.2018.08.042 Copyright © 2018 AGA Institute Terms and Conditions

Figure 1 Clinical remission in (A) ITT population, and (B) PP population during the double-blind phase of the study. Clinical remission was defined as ≤21 stools including ≤6 watery stools in the 7 days before week 8 or withdrawal visit (LOCF method). Gastroenterology 2018 155, 1795-1804.e3DOI: (10.1053/j.gastro.2018.08.042) Copyright © 2018 AGA Institute Terms and Conditions

Figure 2 Time to clinical remission, defined as the time to first of ≥7 days each with, on average, ≤3 stools per day, including <1 watery stool per day (ITT population). The upper limit of the 95% CI values could not be calculated for the placebo group. Gastroenterology 2018 155, 1795-1804.e3DOI: (10.1053/j.gastro.2018.08.042) Copyright © 2018 AGA Institute Terms and Conditions

Figure 3 Mean number of days with (A) watery stools and (B) solid stools in the week before visit (ITT population). BL, baseline (day 0). Gastroenterology 2018 155, 1795-1804.e3DOI: (10.1053/j.gastro.2018.08.042) Copyright © 2018 AGA Institute Terms and Conditions

Supplementary Figure 1 Patient disposition during the double-blind phase of the study. Gastroenterology 2018 155, 1795-1804.e3DOI: (10.1053/j.gastro.2018.08.042) Copyright © 2018 AGA Institute Terms and Conditions

Supplementary Figure 2 Patient disposition during the follow-up phase of the study. Gastroenterology 2018 155, 1795-1804.e3DOI: (10.1053/j.gastro.2018.08.042) Copyright © 2018 AGA Institute Terms and Conditions