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This guidance also describes enrichment strategiestargeted inclusion of certain populations with the goal to more readily demonstrate a drug effectand recommends that even with enrichment, trials should keep their enrollment criteria as broad and representative as possible

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It inhibits NOTCH1 signaling by using its GCT activity to cleave a -glutamyl-cysteine bond at glutamate 1669 of the immature NOTCH receptor, thereby preventing the essential S1 cleavage and subsequent activation ( FIGURE 6 The physiological importance of this mechanism is underscored by severe developmental phenotypes upon its disruption

You achieve two doses