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IRB approval of research is subject to the requirements of 21 CFR 56.111, which states in part: (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes

In UC Trial I, patients were randomized (3:2) to receive ENTYVIO 300 mg or placebo by intravenous infusion at Weeks 0 and 2