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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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This assures that with enough data, such as that contained in MRFs, the average provides a more accurate estimate of the overall characteristic of the population being studied. Response: We recognize that the extent to which a sample statistic provides a reasonable representation of the population statistic depends, at least in part, on the sample size

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