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Methylcobalamin has been postulated to decrease the neurotoxic effects of homocysteine and identified as a potential treatment for amyotrophic lateral sclerosis (ALS) in preclinical studies. In this double-blind, multicenter trial in Japan, 130 ambulatory patients within 1 year of ALS diagnosis based on Awaji criteria were randomized to methylcobalamin 50 mg intramuscular injection twice weekly, or placebo. Baseline characteristics between groups were similar. Patients were included if they had a forced vital capacity (FVC) >60%, did not require noninvasive ventilation, and had a decline by 1 or 2 points in the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) during a 12-week observation period. Concomitant riluzole …