He, Guiying
Liu, Chun-Feng
Ye, Qinyong
Liu, Zhenguo
Jin, Miao
Shang, Huifang
Chen, Ling
Tuo, Houzhen
Jiang, Hong
Cai, Jifu
Joshi, Kalpesh
Cooper, James
Zi, Lu
Chen, Shengdi
Article History
Received: 3 December 2020
Accepted: 22 April 2021
First Online: 12 May 2021
Declarations
:
: The study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by Research Ethics Committee of Rui Jin Hospital affiliated to Shanghai Jiao Tong University, in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice and applicable country-specific requirements, including US 21 Code of Federal Regulations 312.3(b) for constitution of independent ethics committees and the ethical principles outlined in the Declaration of Helsinki 2013. Written informed consent was obtained from each patient prior to the performance of any study-specific procedures.
: N/A.
: LZ, KJ, and JC are employees of GSK and hold GSK stock. GH, CFL, QY, ZL, MJ, HS, LC, HT, HJ, JCai, and SC were study investigators on this study funded by GSK and have no other relevant disclosures to declare.