The authors would like to thank the patients who have participated in this trial and their families.
Sponsorship for this study, the journal’s rapid service fee, and open access fee were funded by Takeda Pharmaceutical Company Ltd. Takeda Pharmaceutical Company Ltd prepared the protocol, handled the clinical research organizations responsible for site management and monitoring, data management, and statistical analysis and was involved in the preparation and publication of the manuscript. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Medical Writing Assistance
Writing assistance from Sabah Farooq of FireKite, an Ashfield company, part of UDG Healthcare plc, was utilized during the development of this manuscript, which was funded by Takeda Pharmaceutical Company Ltd, in compliance with Good Publication Practice 3 ethical guidelines (Battisti et al., Ann Intern Med 2015;163:461–4).
The authors are also grateful to Michinori Arimitsu, of A2 Healthcare Corporation, for reviewing the study protocol and the clinical study report, for the development of the statistical analysis plan, and for the statistical analysis.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Rimei Nishimura and Takeshi Osonoi contributed to the study design, interpretation of the data, and critically reviewed and edited the manuscript. TO also contributed toward data acquisition. YK contributed to the study design, data analysis and drafting the manuscript. KM contributed to the interpretation of the data and drafting the manuscript. YS contributed to the study design, data analysis, interpretation of the data, and drafting the manuscript. All authors read and approved the final manuscript and all authors agree to be accountable for all aspects of the work, which includes ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Rimei Nishimura has received honoraria from Astellas Pharma Inc, Nippon Boehringer Ingelheim Co. Ltd, Eli Lilly Japan K.K., Kissei Pharmaceutical Co. Ltd, Medtronic Japan Co. Ltd, MSD, Novartis Pharma K.K., Novo Nordisk Pharma Ltd, Sanofi K.K., Sumitomo Dainippon Pharma Co. Ltd., Takeda Pharmaceutical Co., Ltd. He has also received a grant from the Japan Diabetes Foundation. Takeshi Osonoi has received honoraria from Takeda Pharmaceutical Co., Ltd., Novo Nordisk Pharma Ltd, Sanwa Kagaku Kenkyusho Co., Ltd., Astellas Pharma Inc, Mitsubishi Tanabe Pharma Corporation, AbbVie GK, AstraZeneca K.K., Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd., Bayer Yakuhin, Ltd, Sanofi K.K., Japan Tobacco Inc., Abbott, Poxel SA, Kowa Co., Ltd. Yasuhiro Koike is an employee of Takeda Pharmaceutical Co., Ltd, which sponsored the study. Kouji Miyata is an employee of Takeda Pharmaceutical Co., Ltd, which sponsored the study. Yukio Shimasaki is an employee of Takeda Pharmaceutical Co., Ltd, which sponsored the study.
Compliance with Ethics Guidelines
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The study protocol, informed consent form, and other regulation-specified documents were reviewed and approved by the Independent Ethics Committees at Nakakinen Clinic.
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda’s Data Sharing Policy (see https://www.takedaclinicaltrials.com/ for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor’s qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.