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Volume 143, Issue 5, Pages e2 (November 2012)

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1 Volume 143, Issue 5, Pages 1218-1226.e2 (November 2012)
Once-Daily Budesonide MMX® Extended-Release Tablets Induce Remission in Patients With Mild to Moderate Ulcerative Colitis: Results From the CORE I Study  William J. Sandborn, Simon Travis, Luigi Moro, Richard Jones, Theres Gautille, Robert Bagin, Michael Huang, Phil Yeung, E. David Ballard  Gastroenterology  Volume 143, Issue 5, Pages e2 (November 2012) DOI: /j.gastro Copyright © 2012 AGA Institute Terms and Conditions

2 Figure 1 (A) Combined clinical and endoscopic remission at week 8. Modified ITT population, N = 489. *Statically significant (P < .025). (B) Symptom resolution at week 8. Modified ITT population, N = 489. *Statically significant (P < .05). This study was not powered to show a statistical difference between budesonide MMX treatment arms and Asacol. Gastroenterology  , e2DOI: ( /j.gastro ) Copyright © 2012 AGA Institute Terms and Conditions

3 Figure 2 (A) Summary of potential glucocorticoid effects. (B) Morning cortisol levels (mean ± SD). Symbols indicate mean plasma cortisol level for each visit for each treatment. Error bars indicate SDs. Treatments are offset for readability. Dashed lines indicate normal limits (5–25 µg/dL). Gastroenterology  , e2DOI: ( /j.gastro ) Copyright © 2012 AGA Institute Terms and Conditions

4 Supplementary Figure 1 Patient disposition. Safety population, n = 509; modified ITT population, n = 489; completed study, n = 349. Gastroenterology  , e2DOI: ( /j.gastro ) Copyright © 2012 AGA Institute Terms and Conditions


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