Funding for this research was provided by:
Received: 21 July 2020
Accepted: 26 October 2020
First Online: 17 November 2020
Ethics approval and consent to participate
: This study is being conducted in accordance with the Good Clinical Practice guidelines and the guiding principles detailed in the Declaration of Helsinki, and in keeping with applicable local law(s) and regulation(s).Written informed consent to study procedures must be provided by all candidate patients before enrolment. We have registered this study in the Japan Registry of Clinical Trials with registration number jRCTs071190003. Before initiation, the principal investigator was required to consult the Certified Review Board (Kyushu University Certified Institutional Review Board for Clinical Trials: Certification No. CRB718005) and receive approval from the study site’s manager, and to submit a trial plan to the Minister of Health, Labor and Welfare.
: Not applicable.
: The EFFORT study is being funded by Sanofi Pharmaceutical Co., Ltd.Hironaga Satake receives honoraria from Sanofi Co., Ltd. and Yakult Honsha Co., Ltd.Eiji Oki receives honoraria from Yakult Honsha Co., Ltd.All remaining authors have declared no conflict of interest.