Study design
CRB
The DUEL study was a multicenter, randomized, controlled, open-label, parallel-group, interventional, non-inferiority trial conducted in 47 centers in Japan between March 2021 and July 2022. It comprised a 4-week observation period and a 24-week evaluation period (The study received approval from the Osaka University Clinical Research Review Committee (CRB No. CRB5180007), which notified all participating centers of the approval per the Clinical Research Act in Japan. The CRB conducted a central review, and after CRB approval, the investigator of each site obtained permission from their administrator to start the research. The study was conducted according to the ethical principles, clinical research laws, and relevant notifications stipulated in the Declaration of Helsinki (as revised in 2013). This study was registered in the Japan Registry of Clinical Trials under the identifier jRCTs051200054. The investigators explained the study procedures to patients considered suitable for enrollment and their caregivers or alternative representatives, who provided written informed consent once they understood the study procedures and agreed to participate.