Funding for this research was provided by:
Grants‐in‐aid for Scientific Research (200500887B)
Received: 27 July 2020
Accepted: 22 November 2020
First Online: 30 November 2020
Ethics approval and consent to participate:
: The trial was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the institutional review board at each center, and written informed consent was obtained from all participants prior to enrolment.
: Not applicable.
: KI, HC, HN, and HT have received grants, and TO has received personal fees from Shionogi & Co., Ltd. KI, HC, HN, TO, and HT have received grants, and HC, HN, AA, YK, TO, YT, and HT have received personal fees from Boehringer Ingelheim Co. HS and SM are employees of Shionogi & Co., Ltd. and own shares in the company. The other authors do not have any conflicts to declare (ME, MS, YS, TN, and SK).