Mizutani, Yasuyuki
Iida, Tadashi
Ohno, Eizaburo
Ishikawa, Takuya
Kinoshita, Fumie
Kuwatsuka, Yachiyo
Imai, Miwa
Shimizu, Shinobu
Tsuruta, Toshihisa
Enomoto, Atsushi
Kawashima, Hiroki http://orcid.org/0000-0002-3720-781X
Fujishiro, Mitsuhiro
Funding for this research was provided by:
Japan Agency for Medical Research and Development (JP21lk0201142, JP21cm0106704)
Article History
Received: 30 November 2021
Accepted: 8 February 2022
First Online: 24 February 2022
Declarations
:
: Board Name: Nagoya University Hospital Ethical Review Board.Approval Number: 332001.Board Affiliation: Nagoya University Hospital.Phone: + 82–52-744–1958, Email: center@med.nagoya-u.ac.jp.Address: 65 Tsurumai-cho, Showa-ku, Nagoya Japan 466–8560.1) Prior to the implementation of this study, the institutional review board that is designated by the head of the study site will review ethical and scientific appropriateness of this study. This study will be performed after obtaining approval from the institutional review board.2) The investigator will perform this study using the Protocol, information document and consent form approved by the head of the study site based on the opinion of the institutional review board. If the institutional review board directs amendment of the Protocol, etc., the investigator will decide the measures to be taken for that.3) If the Protocol is amended, or if new information related to safety is obtained, the investigator will provide the information to the subjects to confirm their will to continue the study and make a request to the institutional review board to review whether to continue this study.4) The investigator will report the implementation status of this study in writing to the head of the study site once a year or more frequently in response to requests from the institutional review board for continuous review by the institutional review board.
: Not applicable.
: In implementing this study, the investigators and sub-investigators are provided with no funds or services by the manufacturer of the investigational drug or the organisation that tests drug levels. This study will be implemented after being reviewed for conflicts of interest by the institutional review board of our hospital under appropriate management. As for a conflict of interest that may occur in this study, any related persons including the investigators may obtain a reward in the future as inventors of a patent to be filed that is related to this therapy, which will be handled according to the rules of Nagoya University Hospital.