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With regard to the claim of a reduced rate of relapse compared to RYDAPT, the applicant stated that a phase 3 trial demonstrated that the cumulative incidence of relapse (CIR) at 2 years was 40% for RYDAPT [119] and in the QUANTUM First trial, the CIR at 2 years was 31.2% for VANFLYTA and 43.3% with placebo

18 In brief, JAM-A-null mice exhibited enhanced intestinal epithelial permeability, bacterial translocation and elevated colonic lymphocytes, but did not develop spontaneous colitis

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