Table 3.

Composition and responsibilities for the research group

Composition	Member name	Affiliation	Roles and responsibilities
PIs and research physicians	Hongxia Ma Ernest HY Ng Elisabet Stener-Victorin Juan Li Maohua Lai Hua Liu Zhenxing Hu Yongxia Zheng Kewei Quan Meifang Li	1st Affiliated Hospital, Guangzhou Medical University The University of Hong Kong Karolinska Institutet 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University Xuzhou Maternity and Child Health Hospital Hexian Memorial Affiliated Hospital of Southern Medical University 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University	Design and conduct of the study. Preparation of protocol and revisions. Preparation of the investigator's SOP and CRFs. Organising the SC meetings. In each participating centre, a site investigator will be identified and will be responsible for patient identification and recruitment, data collection and completion of CRFs as well as follow-up of study patients and adherence to the study protocol and SOP.
SC	Ernest HY Ng Hongxia Ma Elisabet Stener-Victorin Juan Li Taixiang Wu Maohua Lai Hua Liu Zhenxing Hu Yongxia Zheng Kewei Quan Meifang Li	Chair The University of Hong Kong PIs 1st Affiliated Hospital, Guangzhou Medical University Karolinska Institutet Co-investigators 1st Affiliated Hospital, Guangzhou Medical University Chinese Clinical Trial Registry Site investigators and research physicians 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University Xuzhou Maternity and Child Health Hospital Hexian Memorial Affiliated Hospital of Southern Medical University 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University	Authorisation of the final study protocol. All PIs will be SC members. Reviewing the progress of the study and, if necessary, agreeing to changes to the protocol and/or the SOP to facilitate the smooth running of the study.
TMC (PIs, research physicians, administrators)	Ernest HY Ng Hongxia Ma Elisabet Stener-Victorin Taixiang Wu Juan Li Maohua Lai Hua Liu Zhenxing Hu Yongxia Zheng Kewei Quan Meifang Li	The University of Hong Kong 1st Affiliated Hospital, Guangzhou Medical University Karolinska Institutet Chinese Clinical Trial Registry 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University Xuzhou Maternity and Child Health Hospital Hexian Memorial Affiliated Hospital of Southern Medical University 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University	Study planning. Provide annual risk reports to the DSMB and the ethics committee. Reporting serious unexpected suspected adverse events to the DSMB. Responsible for the trial master file. Budget administration and contractual issues with individual centres. Advice for PIs. Auditing of 6-month feedback forms and deciding when site visits should occur. Assistance with independent ethics committee applications. Data verification. Organisation of the central serum sample collection.
DSMB	Hongying Kuang Mei Han Min Hu	Heilongjiang University of Chinese Medicine Beijing University of Chinese Medicine Goteborg University	Review and interpret the data generated from the study. Ensure the safety of the study participants. Hold regular conference calls. Review the protocol with respect to ethical and safety standards. Monitor the safety of the trials. Monitor the integrity of the data with respect to the original study design. Provide advice on study conduct. Review the progress of the trial. Adjudicate adverse events. Decide on any premature closure of the study.
DCC	Taixiang Wu	Chinese Clinical Trial Registry	Oversee the data collection and management (including quality assurance/compliance measures). Oversee the intrastudy data sharing process. Generate and disclose the randomisation scheme for the study. Design the password of the web-based ResMan database to protect the safety of the data.
Publication Committee	Ernest HY Ng Hongxia Ma Elisabet Stener-Victorin Taixiang Wu Juan Li Maohua Lai Zhenxing Hu	The University of Hong Kong 1st Affiliated Hospital, Guangzhou Medical University Karolinska Institutet Chinese Clinical Trial Registry 1st Affiliated Hospital, Guangzhou Medical University 1st Affiliated Hospital, Guangzhou Medical University Xuzhou Maternity and Child Health Hospital	Publication of study reports. Document the contributions to the study of each author. Draft and revise the manuscript.

CRFs, case report forms; DCC, Data Coordination Centre; DSMB, Data and Safety Monitoring Board; PIs, principal investigators; ResMan, Research Management; SC, Steering Committee; SOP, standard operating procedure; TMC, Trial Management Committee.