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The differences in the proportion of patients with ALT and/or AST increase across these cohorts may be due to varying cohort sizes, different characteristics of the patients included, and conservative real-world practices in the US, such as stepwise dose titration during treatment initiation and treatment interruption at a lower level of ALT or AST elevation of 3 ULN, versus the per-protocol procedures in the French EAP cohorts

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Nat Rev Mol Cell Biol (2017) 18(12):72842