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1 Mecobalamin 50 mg or placebo was administered intramuscularly twice weekly for 16 weeks to 130 ALS patients who had suffered from ALS for less than one year, were classified as “definite”, “probable”, or “probable-laboratory supported” according to the Updated Awaji Criteria, had an ALS severity rating of grade 1 or 2, had a decrease of 1 or 2 points in the total score on the Revised ALS Functional Rating Scale-Revised (ALSFRS-R) 12 weeks prior to administration, and had a forced vital capacity (%FVC) of more than 60%