Received: 1 February 2020
Accepted: 31 March 2020
First Online: 12 May 2020
Ethics approval and consent to participate
: The trial has received ethical approval from the Ethics Committee and Clinical Research Review Board of Kyoto Prefectural University of Medicine, Kyoto, Japan (number: C-844, first edition, 21/December/2010, RBMR-C-1058-1/ 201867, the last edition ver. 2.1, 27/December/2018). This ethical approval covers all the 85 participant institutions. This study is in compliance with the principles of the Declaration of Helsinki and registered in the University Hospital Medical Information Network database (UMIN000004700) (ExternalRef removed) and Japan Registry of Clinical trials (jRCTs051180203). Written informed consent is to be obtained from patient and/or a parent or guardian for patient under 16 years old.
: Not applicable.
: Akihiro Yoneda is a member of the editorial board as an Associate Editor. The other authors declare that they have no competting interests.