Article History
Received: 15 February 2024
Accepted: 20 May 2024
First Online: 28 June 2024
Declarations
:
: The Translational Research Centre for Medical Innovation, a third-party organization that is independent of the primary investigator’s institution, was contracted to perform the trial and manage the data.
: This study was conducted in accordance with the 1964 Declaration of Helsinki and its amendments and the Ministry of Health, Labor, and Welfare’s Ethical Guidelines for Clinical Research and under the Japanese Health Insurance System. The study protocol was approved by the ethics committee of the main institution (Nagoya University, no.2014–0027) and of each institution (Niigata University, no.2023–0014; Japanese Red Cross Fukuoka Hospital, no.23021). The study was registered with Clinical Trials.gov (NCT02136563) and UMIN-CTR (UMIN000013464).
: Written informed consent was obtained from all participants.