Nakajo, Ikumi
Inoue, Hiroshi
Inaba, Masaki
Oikawa, Keishi
Katashima, Masataka
Sawamoto, Taiji
Kurumatani, Hajimu
Shiramoto, Masanari
Funding for this research was provided by:
Astellas Pharma, Inc.
Toray Industries, Inc.
Article History
Accepted: 22 March 2021
First Online: 28 April 2021
Declarations
:
: This study was sponsored by Astellas Pharma Inc. and Toray Industries, Inc.
: I. Nakajo, H. Inoue, M. Inaba, K. Oikawa, M Katashima, and T. Sawamoto are paid employees of Astellas Pharma Inc. H. Kurumatani is a paid employee of Toray Industries, Inc. M. Shiramoto has nothing to declare. His current affiliation is Kashiihara Hospital; this manuscript does not represent the opinions of his current affiliation.
: This study was approved by the Institutional Review Board (SOUSEIKAI Kyushu Clinical Pharmacology Research Clinic IRB, Fukuoka, Japan). The study was conducted in accordance with Good Clinical Practice, International Council for Harmonisation guidelines, applicable regulations and guidelines governing clinical study conduct, and the ethical principles of the Declaration of Helsinki.
: Written informed consent was obtained from all individual participants included in the study.
: Not applicable.
: Researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials at ExternalRef removed. For Astellas’ criteria for data sharing, see: ExternalRef removed.
: Data processing, summarization, and statistical analyses were performed using SAS<sup>®</sup> version 9.1.3 and 9.4 (SAS<sup>®</sup> Institute Inc. Cary, North Carolina). Calculation of the pharmacokinetic parameters was performed using Phoenix™ WinNonlin<sup>®</sup> version 6.1 (Certara USA, Inc. Princeton, New Jersey). Figures were created using Microsoft<sup>®</sup> Excel<sup>®</sup> for Office 365 MSO.
: Study design: IN, HI, MI, KO, MK, TS, HK, and MS. Conduct and acquisition of data: IN, HI, MI, KO, and MS. Analysis and interpretation of data: IN, HI, MI, KO, MK, TS, HK, and MS. Writing of the manuscript: IN, HI, MI, KO, MK, TS, HK, and MS.