Received: 27 July 2020
Accepted: 23 November 2020
First Online: 10 December 2020
Ethics approval and consent to participate
: This multicenter open-labeled study was conducted in conformity with the International Council for Harmonization (ICH)—Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol was approved by the institutional review boards of Kurume University School of Medicine (No: 17001), Yame General Hospital (No: 17-001), Moriyama Clinic of Internal Medicine, Nagata Hospital, Sugi Cardiovascular Hospital, Yamaguchi Saiseikai General Hospital, Wada Cardiovascular Clinic, Usui Clinic, Chiba Naika Jyunkankika, and Miyazakinaika Medical Clinic: Clinical Research Network Fukuoka (No: 17-E06). This study has been registered in the University Hospital Medical Information Network clinical trials database (UMIN 000027637).
: Written informed consent was obtained from all patients before enrollment.
: KF, Y. Kaida, and YN received consultant fees from Ono Pharmaceutical Co., Ltd. and Kyowa Hakko Kirin. Y. Kurokawa received consultant fees from Ono Pharmaceutical Co., Ltd. RS, SI, and TM received consultant fees from Kyowa Hakko Kirin. The others authors declare that they have no competing interests.