Fig. 1: Eligibility, randomization and follow-up.

Discontinuation of the study refers to all patients who discontinued before the end of the long-term follow-up safety survey period of the study, 6 months after the last dose of study treatment. ^†Withdrawn by physician is noted as reason ‘other’. ^‡Patients included in the analysis for efficacy end points per protocol were those who received ≥1 dose of study treatment and also received allo-HSCT. One patient was randomized to receive vedolizumab but did not receive allo-HSCT; per protocol, this patient was not included in the analysis of efficacy end points but was included in the analysis of safety end points.