Zhao, Ai-mei
Qiu, Wen-ran
Mao, Li-jun
Ren, Jun-guo
Xu, Li
Yao, Ming-jiang
Bilinksi, Kellie
Chang, Dennis
Liu, Jian-xun
Funding for this research was provided by:
Ministry of Science and Technology of the People's Republic of China (2015CB554405)
Ministry of Science and Technology of the People's Republic of China (2012ZX09103201-015)
Article History
Received: 3 October 2017
Accepted: 9 April 2018
First Online: 10 May 2018
Ethics approval and consent to participate
: The trial will be conducted according to the principles of the Declaration of Helsinki (2000 version). Trial organization, data management, monitoring and reporting of the study will also be performed in accordance with the guidelines for Good Clinical Practice (2003 version) and other regulations. The final protocol (version:1.1, 10 December, 2016) and the consent form have been reviewed and approved by the Ethics Committee of Xiyuan Hospital of China Academy of Chinese Medical Sciences (approval number: 2016XLA158-2). Approval will be sought from the Ethics Committee for all protocol amendments prior to dissemination to recruitment site. The trial is registered at ClinicalTrials.gov (NCT03147053). Each participant will receive a Participant Information Sheet which will be explained thoroughly by the investigator, including potential benefits and risks. The principal investigator or their delegated representative will obtain written informed consent from the patient or their legal authorized representative before allocated to a treatment group. In accordance with ethical guidelines, the anonymity, confidentiality, and privacy of participants will be protected. The electronic clinical trial management data system and all electronic data will be password protected. All publication material will refer to general trial results as aggregate data and no individual participant names or identifying information will be released.
: We have gained informed consent for publication of the dataset from patients at the point of recruitment to the trial. All the patient details will be fully anonymous.
: The authors declare that they have no competing interests.
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