Yang, Ting
Cai, Baiqiang
Cao, Bin
Kang, Jian
Wen, Fuqiang
Yao, Wanzhen
Zheng, Jinping
Ling, Xia
Shang, Hongyan
Wang, Chen
Funding for this research was provided by:
AstraZeneca China
Article History
Received: 15 December 2017
Accepted: 19 November 2019
First Online: 13 January 2020
Ethics approval and consent to participate
: The Ethics Committee of the China-Japan Friendship Hospital, the leading site, approved the study protocol and informed consent form (ICF) prior to study initiation (approval number 2016–97). All patients participating in this study voluntarily signed the ICF and received a copy of the ICF before study initiation.Ethics approval was also gained from all other sites involved in the study, including: the Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Ethics Committee (B193), the Peking University Third Hospital Medical Science Research Ethics Committee (D2016071), the First Affiliated Hospital of China Medical University Medical Science Research Ethics Committee (2017–127), the First Affiliated Hospital of Guangzhou Medical College Science Project Review Ethics Committee (2016–71), the Sichuan University West China Hospital Biology Medical Ethics Committee (2016–303), the Ethics Committee Of The Fourth Affiliated Hospital Of China Medical University (EC-2017-KS-038), the First Hospital Of Qiqihar – Clinical Trials Ethics Committee (2017–004), The Beijing Chao-Yang Hospital/Capital Medical University Ethics Committee (2017-8-7-2), the Tangshan People’s Hospital Drug Clinical Trials Ethics Committee (2017–001), the Beijing Huairou Hospital Medical Ethics Committee (2017-NA; site did not participate in the study), the Beijing Mentougou District Hospital Ethics Committee (NA), the Hospital of Yutian County Ethics Committee (NA), the Shanghai Jiaotong University School of Medicine/Renji Hospital Ethics Committee (2017–044), the Hangzhou Red Cross Hospital Clinical Study Ethics Committee (2017–02), the Shanghai Tongji Hospital Ethics Committee (Tong - 398), the Shanghai Yangpu District Central Hospital Ethics Committee (LL-2017-DZX-010), the Tongxiang First People’s Hospital Ethics Committee (NA), the Quzhou People’s Hospital Drug Clinical Trials Ethics Committee (2017-1-1), the Central Hospital of Minhang District/Shanghai Ethics Committee (2017–2), the Tonglu First People’s Hospital Medical Ethics Committee (2017–1; site did not participate in the study), the Shanghai Pudong Gongli Hospital Ethics Committee (20I7-0I-004-FOI), the Shanghai Pudong District People’s Hospital Drug Clinical Trials Ethics Committee (2017–002), the Hospital of Haiyan County Medical Ethics Committee (2017–1), the First People’s Hospital of Chunan County Ethics Committee (2017–1), the People’s Hospital of Changshan County Medical Ethics Committee (NA), the First Affiliated Hospital of Xinjinag Medical University Medical Ethics Committee (2017–0605-01), the Baoji Central Hospital Drug Clinical Trials Ethics Committee (2017–03), the Shaanxi Sengong Hospital Biology Medical Ethics Committee (2017–1), the Hospital of Qishan County Medical Ethics Committee (2017–1), the Second People’s Hospital of Yibin National Drug Clinical Trials Ethics Committee (2017–005-01), the Chengdu Fifth People’s Hospital Ethics Committee (2017-01-01), the Chengdu Pidu District People’s Hospital Medical Ethics Committee (2017–07), the People’s Hospital of Pengan County Ethics Committee (2017–002), the Sichuan Forestry Central Hospital Medical Ethics Committee (2017–001), the First People’s Hospital of Foshan Ethics Committee (2017–1), the Third Affiliated Hospital of Zhongshan Medical University Clinical Medical Research Ethics Committee (2017–2-165), the Second Hospital/University of South China Drug Clinical Trials Ethics Committee (201704–06), the Medical Ethics Committee of Xiangya Hospital Central South University (201708101), the Guangzhou Baiyun District People’s Hospital Ethics Committee (2017–1), the Wuhan Red Cross Hospital Biology Medical Ethics Committee (2017–1), the Guangzhou Panyu District Ho Hsien Memorial Hospital Ethics Committee (NA), the Luoyang New District People’s Hospital Ethics Committee (NA), the Yueyang Yuehua Hospital Ethics Committee (2017–01), the Shengjing Hospital Dalian Hospital of China Medical University Ethics Committee (2017–1), the People’s Hospital of Qinlai County Medical Ethics Committee (2017–01), the Liaoning Electric Power Hospital Medical Ethics Committee (2017–01), the Changchun Second Hospital Ethics Committee (2017–01), the Longkou People’s Hospital Ethics Committee (NA), the Xuzhou Mine Hospital Ethics Committee (2018–01), Independent Ethics Committee for Clinical Research of Zhongda Hospital/Affiliated to Southeast University (2017ZDSYLL021-YOI; site did not participate in the study), the 180th Hospital of PLA Medical Ethics Committee (2017–1; site did not participate in the study), and the General Hospital of Shenyang Military Medical Ethics Committee (2017–18; site did not participate in the study).
: Not applicable.
: TY, BCai, BCao, JK, FW, WY, JZ, and CW declare that they have no competing interests.HS is an employee of AstraZeneca China. XL is a previous employee of AstraZeneca China.AstraZeneca China will be involved in interpretation of the results.