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Authors
Kasai, Takashi https://orcid.org/0000-0002-3112-4001
Mori, Kiyoshi
Sugiyama, Tomohide
Koyama, Nobuyuki
Nakamura, Yoichi
Ohyanagi, Fumiyoshi
Fukuda, Hiroki
Hoshi, Eishin
Kobayashi, Kunihiko
Nakayama, Mitsuo
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Article History
Received: 10 June 2022
Accepted: 17 August 2022
First Online: 14 October 2022
Declarations
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: The authors have no conflicts of interest to declare.
: The present study was conducted in accordance with the Declaration of Helsinki. All patients provided written, informed consent according to the protocol before study entry. Patients were recruited at three investigational sites of the Kanto Respiratory Disease Study Group (KRSG) in Japan. This single-arm, phase I/II clinical trial was registered with the UMIN Clinical Trials Registry (number UMIN 000013219). All study protocols were approved by the ethics committees of Tochigi Cancer Center and all participating centers. The names of all ethics committees and all approval reference numbers of this study protocol are as follows: Ethics Committee of Tochigi Cancer Center. (No.A-242), Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center. (No. 13–85). Institutional Review Board for Ethics in Clinical Study of Saitama Medical Center, Saitama Medical University. (No. 990-II).
