Li, Ji
Liu, Zhanju
Hu, Pinjin
Wen, Zhonghui
Cao, Qian
Zou, Xiaoping
Chen, Yan
Wang, Yingde
Zhong, Jie
Shen, Xizhong
Demuth, Dirk
Fadeeva, Olga
Xie, Li
Chen, Jun
Qian, Jiaming
Article History
Received: 29 March 2021
Accepted: 10 December 2021
First Online: 4 February 2022
Declarations
:
: This study was conducted in accordance with local regulatory and ethics committee approvals in China. Ethical approval for the study was obtained from the Ethics Committee of The First Affiliated Hospital of Dalian Medical University; Ethics Committee of Zhongshan Hospital Fudan University; Ethics Committee of Peking Union Medical College Hospital; Ethics Committee of The Sixth Affiliated Hospital of Sun Yat-sen University; Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine; Clinical Trial Ethics Committee of West China Hospital, Sichuan University; Ethics Committee of No. 10 People's Hospital of Shanghai; Ethics Committee of Ruijin Hospital Shanghai Jiao Tong University School of Medicine; Ethics Committee of The Second Affiliated Hospital of Zhejiang University School of Medicine; and Ethics Committee of The Affiliated Drum Tower Hospital of Nanjing University. Written informed consent for all living patients was obtained at two sites (The First Affiliated Hospital of Dalian Medical University and Zhongshan Hospital Fudan University). A waiver of informed consent was granted at the remaining eight sites (Peking Union Medical College Hospital; The Sixth Affiliated Hospital of Sun Yat-sen University; Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine; West China Hospital, Sichuan University; No. 10 People's Hospital of Shanghai; Ruijin Hospital Shanghai Jiao Tong University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine; and The Affiliated Drum Tower Hospital of Nanjing University) because data were obtained via retrospective chart review. The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the institution’s human research committee.
: Not applicable.
: DD and OF are employees of Takeda Pharmaceutical International AG Singapore. LX and JC are employees of Takeda (China) International Trading Co. Ltd. DD and LX hold stock options for Takeda Pharmaceutical Co. Ltd. JQ is an advisory committee/board member for Takeda Pharmaceuticals Co. Ltd. JL, JZ, PH, QC, XS, XZ, YC, YW, ZL, and ZW have nothing to disclose.