Tsukada, Nobuhiro
Nishikori, Momoko
Goto, Hiroaki
Kanamori, Rie
Nishina, Satoshi
Seto, Takashi
Iida, Shinsuke http://orcid.org/0000-0002-4951-960X
Funding for this research was provided by:
Sanofi K.K.
Article History
Accepted: 9 August 2021
First Online: 29 August 2021
Declarations
:
: This study was funded by Sanofi K.K.
: 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.
: Nobuhiro Tsukada has received payment for lectures, including service on speaker’s bureaus, from Takeda Pharmaceutical Company Limited and Sanofi K.K. Momoko Nishikori has received grants from Eisai Co., Ltd. and Sumitomo Dainippon Pharma Co., Ltd. and fees for participation in review activities such as data monitoring boards from Sanofi K.K. Hiroaki Goto has received fees for participation in review activities such as data monitoring boards from Amgen K.K., Novartis Pharma K.K., Nippon Shinyaku Co. Ltd., and Bayer Yakuhin Ltd.; has received payment for writing or reviewing manuscripts and delivering lectures, including service on speaker’s bureaus, from Amgen K.K. Rie Kanamori and Takashi Seto are employees of Sanofi K.K. Satoshi Nishina is an employee of Sanofi K.K. and holds stocks/stock options in this company. Shinsuke Iida has received grants, or has grants pending on behalf of Sanofi K.K., Takeda Pharmaceutical Company Limited, Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb K.K., Celgene Corporation, Janssen Pharmaceutical K.K., Daiichi Sankyo Co. Ltd., Chugai Pharmaceutical Co. Ltd., Kyowa Kirin Co. Ltd., GlaxoSmithKline, and Abbvie Inc.; and has received consulting fees or honorarium from Sanofi K.K., Takeda Pharmaceutical Company Limited, Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb K.K., Celgene Corporation, Janssen Pharmaceutical K.K., Daiichi Sankyo Co. Ltd.
: Qualified researchers may request access to patient-level data and related documents (including, for example, the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications). Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data-sharing criteria, eligible studies, and process for requesting access can be found at ExternalRef removed.
: SN and TS contributed to study conception/design, data acquisition and data analysis. All authors contributed to data interpretation and writing the manuscript and approved the final draft for submission.
: This study was conducted in accordance with the Japanese regulatory requirements of good post-marketing study practice, and the protocol of this study was approved by the Ministry of Health, Labour and Welfare of the Japanese government. The need for ethics approval and informed consent was waived as this study was mandated by the Japanese regulatory authorities in accordance with the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (Pharmaceutical and Medical Device Act).
: The study was conducted in accordance with the Japanese regulatory requirements of good post-marketing study practice.
: As this was a mandatory post-marketing study, informed consent from individual patients was not required.
: Not applicable.