Trial design
CPT-MM301 was a multicentre, randomized, double-blinded, placebo-controlled phase 3 trial conducted in China. The trial protocol was designed by sponsors and investigators, and was approved by the independent ethics committees of Beijing Chao-Yang Hospital Capital Medical University. The trial was conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. All patients provided written informed consent before enrolment. The data were collected, analysed, and interpreted by investigators and sponsor. Investigators had full accessibility to all data. The trial was registered at 