Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment.

"DISCLOSURE A. Genge has served as a consultant for Mitsubishi Tanabe Pharma, Inc. G. L. Pattee has served as a consultant for Mitsubishi Tanabe Pharma, Inc. G. Sobue has served as medical advisor for Mitsubishi Tanabe Pharma Corporation. M. Aoki has served as medical advisor for Mitsubishi Tanabe Pharma Corporation. H. Yoshino has served as medical advisor for Mitsubishi Tanabe Pharma Corporation. P. Couratier has served as a consultant for Biogen and as an editor for Elsevier. C. Lunetta has served as a scientific consultant for Mitsubishi Tanabe Pharma Europe, Cytokinetics, Neuraltus, and Italfarmaco. S. Petri has served as a scientific consultant for Cytokinetics, Biogen, and Roche, and received speaker's honoraria from Biogen, Roche, and Italfarmaco. D. Selness is an employee of Mitsubishi Tanabe Pharma Development America, Inc. M. Hirai is an employee of Mitsubishi Tanabe Pharma Corporation. T. Sakata is an employee of Mitsubishi Tanabe Pharma Corporation. A. Salah is an employee of Mitsubishi Tanabe Pharma America, Inc. S. Apple is an employee of Mitsubishi Tanabe Pharma America, Inc. A. Wamil is an employee of Mitsubishi Tanabe Pharma Development America, Inc. A. Kalin is an employee of Mitsubishi Tanabe Pharma Development America, Inc. C. E. Jackson serves on the Data and Safety Monitoring Board for Mitsubishi Tanabe Pharma America, Inc., and Anelixis."

"Funding information Mitsubishi Tanabe Pharma America, Inc.; Mitsubishi Tanabe Pharma Development America, Inc."

"Approvals were received from ethical standards committees on human experimentation (institutional or regional) for this clinical study. Written informed consent was obtained from all patients participating in this study. This trial was registered with Clinicaltrials.gov, number NCT04165824 (https://clinicaltrials.gov/ct2/show/NCT04165824)."