He, Jinjie
Cao, Guoying
Yu, Jicheng
Wang, Jingjing
Cheng, Nengneng
Wu, Jufang
Zhang, Jing http://orcid.org/0000-0003-2966-9149
Wu, Xiaojie
Zhang, Basheng
Lu, Jiayan
Chen, Shangzhi
Article History
Accepted: 5 November 2020
First Online: 23 December 2020
Declarations
:
: This study was funded by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. China.
: B. Zhang, J. Lu, and S. Chen are employees of Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. China. J. He, G. Cao, J. Yu, X. Wu, J. Wang, J. Wu and J. Zhang are employed by the Huashan Hospital, Fudan University, Shanghai, China, which received funding from Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. China to carry out this study. N. Cheng declares he has no conflict of interest.
: The study protocol and informed consent documents were approved by the Ethics Committee of Huashan Hospital, meanwhile the study was licensed in National Medical Products Administration (NMPA) in China with the registration number of 2017L04362, and the Identifier in ClinicalTrials.gov was NCT03458650. Study conduct was in accordance with the principles of International Conference on Harmonization, Declaration of Helsinki, NMPA, and Good Clinical Practice.
: Written informed consent was obtained from all individual participants included in the studies before commencing any study-related procedures.
: Not applicable.
: Not applicable.
: Not applicable.
: JH and GC contributed to subject recruitment, sample and data collection, biological analysis, and writing of the manuscript. JY and XW was contributed to sample collection and managed investigational drug. NC contributed to data analysis and manuscript review. JW contributed to collect samples as nurse. JW contributed to clinical observation as a doctor. JZ contributed to management of the clinical trial process.