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The approval is based on the Phase III NAPOLI 3 trial, where the Nalirifox regimenwhich combines Onivyde with fluorouracil, oxaliplatin and leucovorinboosted overall survival (OS) by a statistically significant 17% compared to standard of care

Such episodes were reported in 4.1%, 7.3%, and 5.7% in the placebo, 25 mg and 50 mg methylcobalamin groups, respectively

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