Ethics approval and consent to participate
The study was conducted in accordance with standards of Good Clinical Practice as defined by the International Conference on Harmonisation and all applicable federal and local regulations. All study documentation was approved by the local review board at each site or by a central institutional review board/ethics committee; there were a total of 40 sites: The First Affiliated Hospital of Guangzhou Medical University (Guangzhou, Guangdong, China, 510120), Beijing Chaoyang Hospital Capital Medical University (Beijing, China, 100020), Beijing Anzhen Hospital, Capital Medical University (Beijing, China, 100029), Peking University First Hospital (Beijing, China, 100034), Xuanwu Hospital Capital Medical University (Beijing, China, 100053), Peking Union Medical College Hospital (Beijing, China, 100730), Chinese PLA General Hospital (Beijing, China, 100853), Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) (Beijing, China, 610041), The First Hospital of Jilin University (Changchun, China, 130021), The Second Hospital of Jilin University (Changchun, China, 130022), The First Affiliated Hospital of Chongqing Medical University (Chongqing, China, 400016), The Affiliated Hospital of Guizhou Medical University (Guiyang, China, 550000), Mianyang Central Hospital (Mianyang, China, 621000), Jiangxi Pingxiang People's Hospital (Pingxiang, China, 337055), People's Hospital of Rizhao (Rizhao, China, 276826), Shengjing Hospital of China Medical University (Shenyang, China, 110004), General Hospital of Northern Theater Command (Shenyang, China, 110015), The University of Hong Kong—Shenzhen Hospital (Shenzhen, China, 518053), Shanxi Provincial People Hospital (Taiyuan, China, 030012), The 2nd Affiliated Hospital of Wenzhou Medical University (Wenzhou, China, 325035), Union Hospital Tongji Medical College Huazhong University of Science and Technology (Wuhan, China, 430022), Renmin Hospital of Wuhan University (Wuhan, China, 430060), The First Affiliated Hospital of Xi'an Jiaotong University (Xi'an, China, 710061), People's Hospital of Zhengzhou (Zhengzhou, China, 450003), The First Affiliated Hospital of Zhengzhou University (Zhengzhou, China, 450052), Affiliated Hospital of Jiangsu University (Zhenjiang, China, 212001), Pineo Medical Ecosystem (Tbilisi, Georgia, 0114), Aversi Clinic LTD (Tbilisi, Georgia, 0160), Nowon Eulji Medical Center, Eulji University (Seoul, Korea, Republic of, 01830), Severance Hospital Yonsei University Health System—PPDS (Seoul, Korea, Republic of, 03722), Samsung Medical Center—PPDS (Seoul, Korea, Republic of, 06351), Hospital Universitario Puerta de Hierro—Majadahonda (Majadahonda, Madrid, Spain, 28222), Hospital Universitario Vall d'Hebron—PPDS (Barcelona, Spain, 8035), Hospital Universitario La Paz—PPDS (Madrid, Spain, 28046), Hospital Clinico Universitario de Valencia (Valencia, Spain, 46010), Hospital Universitari i Politecnic La Fe de Valencia (Valencia, Spain, 46026), Hospital Clinico Universitario Lozano Blesa (Zaragoza, Spain, 50009), Taipei Veterans General Hospital (Taipei City, Taiwan, 11217), Tri-Service General Hospital (Taipei, Taiwan, 11490), Chang Gung Memorial Hospital, Linkou (Taoyuan City, Taiwan, 33305). All patients provided written informed consent prior to their participation in the study.