Study design
This was a phase III, randomized, placebo-controlled, double-blind, parallel-group, multicenter study conducted at five sites in Japan (Department of Neurology at Tohoku University Hospital, National Center Hospital, NCNP; Nagoya University Hospital; Osaka University Hospital; and Kumamoto University Hospital), in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and study protocol. This study was reviewed in terms of ethical, scientific, and medical validity and approved by the institutional review board at each site before the start of the study. The study lasted from Feb 8, 2021 to March 29, 2022. The study is registered on ClinicalTrials.gov (NCT04671472).