Yamamoto, Hiroyasu http://orcid.org/0000-0002-5169-0350
Yamada, Takashi
Miyazaki, Ken
Yamashita, Takuto
Kato, Takuya
Ohara, Kenichi http://orcid.org/0000-0003-4513-390X
Nakamura, Yusuke
Akizawa, Tadao http://orcid.org/0000-0002-6150-9201
Funding for this research was provided by:
Bayer Yakuhin, Ltd.
Article History
Received: 6 February 2023
Accepted: 12 April 2023
First Online: 24 April 2023
Declarations
:
: H.Y. received consulting and lecture fees from Bayer Yakuhin, Ltd., Kyowa Kirin Co Ltd., and Astellas Pharma Inc. during the study. T.Y., K.M., T.Y., T. K., K.O., and Y.N. are employees of Bayer Yakuhin, Ltd. T.A. received consulting and lecture fees from Bayer Yakuhin, Japan Tobacco, Astellas Pharma Inc., GlaxoSmithKline, Torii Pharmaceutical, Kyowa Kirin Co Ltd, Kissei, Mitsubishi Tanabe, and Chugai during the study.
: Regarding the clinical trials on which these data were based, documented approval from appropriate independent ethics committees and institutional review boards was obtained. The MIYABI ND-C study was approved by the Institutional Review Board of Kyushu University Hospital (application number: 20171211), Nihon University Hospital (application number: 20171130), and 60 other sites. The MIYABI ND-M study was approved by the Institutional Review Board of Kyushu University Hospital (application number: 20171211), Nihon University Hospital (application number: 20171130), and 59 additional sites in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
: Written informed consents were obtained from the patients by the site investigator or a designated person before entering the clinical trials and may be withdrawn at any time.