Received: 27 September 2020
Revised: 17 November 2020
Accepted: 2 December 2020
First Online: 7 January 2021
Ethics approval and consent to participate
: This study was conducted in accordance with the Declaration of Helsinki and comparable Japanese ethical standards and was approved by the institutional review board of each participating institution (Supplementary Table InternalRef removed). Furthermore, we obtained written informed consent from all study participants. All authors had access to the study data and reviewed and approved the final paper.
: Not applicable.
: All data generated or analysed during this study are included either in this paper or in the supplementary information.
: H. Ueno received honoraria and research funding for his institution from Taiho, Chugai and Yakult Honsha; M.I. received honoraria and a consulting/advisory fee from Taiho and research funding from Taiho and Yakult Honsha; T.I. received honoraria from Taiho and Chugai; H. Uetake received research funding for his institution from Chugai, Taiho, Yakult Honsha, Takeda, Bayer and Merk; K.M. received honoraria from Taiho and Chugai; S.T. received honoraria from Chugai and Takeda; M.K. received honoraria from Chugai, Taiho and Yakult Hosha; N.T. received honoraria and research funding for his institution from Taiho and Chugai; E.N., S.M., T.S., Y.A., H.M., M.T., Y.M., T.Y., H.K., M.F. and K.S. have nothing to declare.
: This study was supported by the Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation (TRI), under the funding contract with Taiho Pharmaceutical Co. Ltd., Japan. The funding sources had no role in the design of the study; collection, analysis or interpretation of the data; writing of the report; the decision to submit for publication.