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and were included in the analysis on an intention-to-treatbasis. Four patients from the rituximab group and 20 fromthe placebo group had discontinued the intervention,mostly because of treatment failure. However, no patientsdropped out of the study before the first relapse (the primary endpoint). All of the patients with treatment failure inthe placebo group were enrolled into RCRNS02 after discontinuation (N = 18) or completion (N = 2) ofRCRNS01. Baseline characteristics were similar betweenthe two groups. All of the patients were treated with steroids and/or immunosuppressants at relapse immediatelybefore assignment. Over 70 % of patients reported sideeffects from steroid treatment.
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