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Article History

Received: 31 August 2021

Accepted: 13 April 2022

First Online: 20 April 2022

Declarations

:

: This study was approved by the institutional review boards of the participating institutions (Shimonoseki City Hospital IRB, Hakodate General Central Hospital IRB, Medical Corporation Jinsenkai Hanna Hospital IRB, Kanazawa Medical University Hospital IRB, Shiga General Hospital IRB, University Hospital Kyoto Prefectural University of Medicine IRB, National Hospital Organization, Higashi-Hiroshima Medical Center IRB, Medical Corporation Shintokai Yokohama Minoru Clinic IRB, Jimbo Orthopedics IRB, Hamanomachi Hospital IRB, Steel Memorial Yawata Hospital IRB, All Tohoku Clinical Trial Review and Audit Organization IRB, Tokyo Medical And Dental University, Medical Hospital IRB, Yokohama City University Hospital IRB, Toyama Prefectural Central Hospital IRB, Osaka General Medical Center IRB, Kakogawa Central City Hospital IRB, Kyushu University Institutional Review Board for Clinical Trials for Approval of Drugs/Equipment, Kanazawa University Hospital IRB, Hiroshima University Certified Review Board, St. Luke’s International Hospital IRB, Showa University Fujigaoka Rehabilitation Hospital IRB, Review Board of Human Rights and Ethics for Clinical Studies Ethics Review Committee, Kobe University Hospital IRB, Adachi kyousai Hospital IRB, Takakura Orthopaedic & Sports Clinic IRB, Nihonbashi Sakura Clinic IRB, Japan Community Health Care Organization Osaka Hospital IRB, Koseiren Hospital Central Institutional Review Board, Medical Corporation Jinsenkai Hanna Hospital IRB, Shinagawa East One Medical Clinic IRB, Himeji St. Mary’s Hospital IRB, Dokkyo Medical University Saitama Medical Center IRB, Haradoi Hospital IRB, Marunouchi Hospital IRB).This study was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonization Good Clinical Practice Guidelines. All patients provided written informed consent before being enrolled in this study.

: Not applicable.

: TKub, TKum, and HI received personal fees from Seikagaku Corporation. KK, MN, and TS are employees of Seikagaku Corporation.