Research involving human participants and/or animals/ethical approval
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.