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However, regulatory decisions are based on comprehensive reviews of clinical data, manufacturing information, and safety assessments

Kido J, Matsumoto S, Hberle J, Inomata Y, Kasahara M, Sakamoto S, Horikawa R, Tanemura A, Okajima H, Suzuki T, Nakamura K (2021b) Role of liver transplantation in urea cycle disorders: report from a nationwide study in Japan