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The approval was supported by the Phase III VISIBLE 2 study, where a statistically significant proportion of patients receiving 108 mg of Entyvio SC maintenance therapy administered every two weeks achieved long-term clinical remission compared to the placebo group after 52 weeks

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Experimental and clinical data also demonstrate transient immunosuppression (reductions in immune cell numbers up to 48 h, cytokine changes beyond 96 h), which is biologically consistent with the infection signals discussed below

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