Study design
The study was a phase 3, multicenter, double-blind, randomized, fixed-dose, placebo-controlled clinical trial. The trial was conducted at 22 centers in China from December 2018 to December 2020. It was performed in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. All patients provided written informed consent prior to enrollment. Ethical approval was obtained from the local research ethics committees. See the full protocol in the supplementary information protocol.