Wang, Zhen
Zhang, Xin
Qu, Yanling
Zhang, Shuyang
Chen, Yundai
Chen, Xiaoping
Qi, Xin
Liu, Peijing
Liu, Shuqin
Jiang, Shan
Man, Ronghai
He, Liping
Wu, Ling
Li, Zhanquan
Shang, Yijun
Qiu, Zhaohui
Liu, Feng
Xu, Chenhong
Lai, Chunlin
Ge, Junbo
Article History
Received: 6 January 2023
Accepted: 29 May 2023
First Online: 10 June 2023
Declarations
:
: This multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial was conducted in 39 research centers in China. The research protocol adhered to the International Conference on Harmonization Guidelines for Good Clinical Practice, and regulations and directives set forth by autonomous local and/or national ethics committees. The Helsinki Declaration was followed in conducting all procedures. Institutional review boards granted approval of the protocol, consent forms, and additional pertinent documentation. Prior to the commencement of the study, signed informed consent were provided by all patients. The registration number was CTR20170362 (available at: ExternalRef removed).
: The authors declare no competing interests.