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This approval is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), multicenter, placebo-controlled, double-blind, randomized Phase III clinical trial in 130 patients with ALS, that was conducted as an investigator-initiated trial by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University, and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, and Professor Satoshi Kuwabara (Coordinating Investigator), the Department of Neurology, Chiba University Graduate School of Medicine