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Takeda is supporting the BLA with data from the pivotal VISIBLE 2 Phase III trial, in which 409 adult patients experienced a clinical responsedefined as a decrease of 70 points or more in Crohns Disease Activity Index (CDAI) score from baselinefollowing two doses of open-label IV Entyvio

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Risk monitoring and safety considerations Safety remains a critical aspect of implementation

Many patients begin with 4-8 week initial cycles to establish baseline response and assess cognitive improvements, with some protocols extending to 12+ weeks for comprehensive neuroplasticity enhancement

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