Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study.

Reassuringly, the sensitivity analysis in which all the patients who were randomised and dosed (ie, the conventional intention-to-treat population) were analysed (with patients excluded from the mITT population set to non-responder imputation) still showed a highly significant effect of budesonide MMX 9 mg versus placebo on combined clinical and endoscopic remission rates (15.1% vs 3.1%, respectively, p=0.0008).

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Although numerically more patients achieved combined clinical and endoscopic remission with budesonide MMX 6 mg compared with placebo, this difference did not reach statistical significance.

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