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Article History

Received: 6 October 2022

Accepted: 18 April 2023

First Online: 1 May 2023

Declarations

:

: This study is being and has been conducted in accordance with the Declaration of Helsinki Ethical Guidelines for Clinical Research, Clinical Trials Act (since 1 April 2018), and all applicable laws and regulations, including, without limitation, data privacy laws and conflict of interest guidelines. Before the enactment of the Clinical Trials Act, this study was conducted in accordance with the Ethical Guidelines on Biomedical Research Involving Human Subjects (the Ministry of Education, Culture, Sports, Science and Technology [MEXT] and the Ministry of Health, Labour and Welfare [MHLW], 22 December 2014; this guideline has since been renamed the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects). Owing to the enforcement of the Clinical Trials Act in Japan on 1 April 2018, VISION was classified as a ‘Specified Clinical Trial’ on 21 November 2018. The transformation review was conducted at ‘Certified Review Board of National Center for Global Health and Medicine’ (CRB3180021) certified by MHLW, and after that the study was approved and registered under the trial ID jRCTs031180040. Prior to this classification, the study was reviewed by the Ethical Review Boards of each study site (including Ethics Committee: Tohoku University Hospital, reference [ref] no. 2015–2-252; Shiga University of Medical Science Research Ethics Committee, ref no. 27–199; Japan Community Health care organization Ethics Review Committee; The Shimane University Institutional Committee on Ethics, ref no. 20160128–3; The Ethics Review Board of Hyogo College of Medicine, ref no. 318; KKR Takamatsu Hospital Institutional Review Board, ref no. E105; Matsuyama Red-cross Hospital Medical Ethics Committee, ref no. 554; Kyushu University Certified Institutional Review Board for Clinical Trials, ref no. 27077; Research Ethics Committee of Kawasaki Medical School and Hospital, ref no. 2383; Institutional Review Board of National Center for Global Health and Medicine, ref no. 2004; Institutional Review Board of National Center for Global Health and Medicine ref no. 2012; Joint Ethical Review Board; Medical Corporation Toukeikai Kitamachi Clinic Ethical Review Board; Maebashi Hirosegawa Clinic Institutional Review Board; Medical Corporation Koyasu Koyasu Neurosurgical Clinic Ethical Review Board; National Hospital Organization Hakodate National Hospital Ethics Review Committee, ref no. H28-0314004; Haradoi Hospital Ethical Review Board; Hospital Ethics Committee Juntendo University Hospital ref no. 16–014; Junpukai Health Maintenance Center Institutional Review Board, ref no. 20160001). Informed written consent was obtained from all study participants before any protocol-specific study procedures.

: Not applicable.

: Yoshikazu Kinoshita received consulting fees for speaking and teaching from AstraZeneca KK, Takeda Pharmaceutical Company Ltd., Daiichi-Sankyo Inc., and Otsuka Pharmaceutical Ltd.Junichi Akiyama received other financial benefits for speaking and teaching, from Takeda Pharmaceutical Company Ltd.Tatsuhiro Kanoo, Kouji Miyata, and Naomi Kusumoto are employees of Takeda Pharmaceutical Company Ltd.Ken Haruma, Naomi Uemura, Takashi Yao, Ryoji Kushima, and Nobuo Aoyama have no conflicts to declare.