Funding for this research was provided by:
Text and Data Mining valid from 2020-05-04
Received: 24 December 2019
Accepted: 23 March 2020
First Online: 4 May 2020
Ethics approval and consent to participate
: The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and the requirements of the China Food and Drug Administration. An independent ethics committee approved the study at each study site: Peking Union Medical College Hospital Ethics Committee; West China Hospital, Sichuan University Ethics Committee; Huashan Hospital, Fudan University Ethics Committee; Huazhong University of Science and Technology Clinical Trial Ethics Committee; The First Affiliated Hospital, Sun Yat-sen University Ethics Committee; The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital) Ethics Committee; The Second Hospital of Hebei Medical University Ethics Committee; The Affiliate Hospital of Guizhou Medical University Ethics Committee; Fujian Provincial Hospital Ethics Committee; Tianjin Medical University General Hospital Ethics Committee. All study documentation was approved by institutional review boards. Key protocol amendments occurring during the study are summarized in Additional file InternalRef removed.Patients provided written (dated and signed) informed consent to participate in the core study and the PK subgroup. Patients could withdraw at any time during the study either at their own request or if, in the opinion of the investigator, there were safety concerns.This article does not contain any studies with animals performed by any of the authors.
: Not applicable.
: LDG is an employee of Ipsen Innovation. YW is an employee of Ipsen Pharma. NW was an employee of Ipsen Pharma at the time of the study and manuscript development. ZN, TL, LD, PH, ZG, LZ and FG have no conflict of interest<i>.</i>