Takahashi, Saki http://orcid.org/0000-0002-2297-2287
Tsuji, Yasuhiro http://orcid.org/0000-0002-7967-2947
Holford, Nick http://orcid.org/0000-0002-4031-2514
Ogami, Chika http://orcid.org/0000-0002-2493-9616
Kasai, Hidefumi
Kawasuji, Hitoshi
To, Hideto
Yamamoto, Yoshihiro
Funding for this research was provided by:
Japan Society for the Promotion of Science (JP20K07189)
Article History
Accepted: 12 February 2023
First Online: 2 March 2023
Declarations
:
: This study was supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant Number JP20K07189 and the Nihon University Multidisciplinary Research Grant for 2020. The funding organization did not participate in the study design, collection, analysis, and interpretation of data, writing of the report, or decision to submit the article for publication.
: The authors have no conflicts of interest to declare.
: The present study was conducted with the approval of the ethics committees of the University of Toyama (approval number: R2012133 revised) and Nihon University (School of Pharmacy, approval numbers: 20–005 and 20–012) and was conducted in compliance with the Declaration of Helsinki.
: Informed consent was obtained to participate in the study.
: Not applicable.
: No data are available.
: A NONMEM code of population pharmacokinetics model will be made available on reasonable request.
: S.T., Y.T., and C.O. contributed to the acquisition of data, participated in the study design, analyzed and interpreted the data, and drafted the manuscript. N.H. helped with writing the manuscript. H.K. (Hidefumi Kasai) and H.T. contributed to the conception, design, and interpretation of the data. H.K. (Hitoshi Kawasuji) and Y.Y. were the clinical investigators of the trial and were responsible for the medical care of the trial participants, communication with the research ethics committee, protocol, informed consent, data integrity, and reporting. All the authors meet the ICME authorship criteria. All the authors approved the final version of the manuscript.