Ding, Zhenbin
Wu, Hong
Zeng, Yongyi
Kuang, Ming
Yang, Wei
Meng, Zhiqiang
Chen, Yajin
Hao, Chunyi
Zou, Shubing
Sun, Huichuan
Liu, Chang
Lin, Kecan
Shi, Guoming
Wang, Xiaoying
Fu, Xiutao
Chen, Rongxin
Chen, Yi
Liang, Ruifang
Kano, Takeshi
Pan, Huiyan
Yang, Suna
Fan, Jia
Zhou, Jian https://orcid.org/0000-0002-2118-1117
Funding for this research was provided by:
Eddingpharm Co., Ltd., China
Shionogi
Article History
Received: 1 July 2022
Accepted: 9 September 2022
First Online: 18 October 2022
Declarations
:
: Ruifang Liang and Suna Yang are employees of Eddingpharm Co., Ltd., China, which funded this study. Takeshi Kano and Huiyan Pan are employees of Shionogi & Co., Ltd., Japan. The remaining authors (i.e., Zhenbin Ding, Hong Wu, Yongyi Zeng, Ming Kuang, Wei Yang, Zhiqiang Meng, Yajin Chen, Chunyi Hao, Shubing Zou, Huichuan Sun, Chang Liu, Kecan Lin, Guoming Shi, Xiaoying Wang, Xiutao Fu, Rongxin Chen, Yi Chen, Jia Fan, Jian Zhou) disclose no conflicts.
: The study was registered at(CTR20192384), and the study protocol (1903M0636) received the requisite approval from the institutional review committee and ethics committee of each site.
: Each participating patient provided written informed consent and the study process strictly adhered to the ethical principles of the Declaration of Helsinki, the International Coordination Committee for the Registration of Drugs for Human Use Clinical trial management regulations E6, and Chinese drug clinical trial management regulations.