Materials and Methods
This study was conducted in full accordance with the Declaration of
Helsinki and Good Clinical Practice guidelines and applicable national
and local laws and regulations. This study has been registered in
Chinese Clinical Trial Registry (ChiCTR) as ChiCTR1800017978 and Drug
Trial Registration and Information Publication Platform
(chinaDrugtrials.org.cn) as CTR20181466.
This study was performed in Phase I Clinical Trial Center, Beijing
Shijitan Hospital affiliated with Capital Medical University ,Beijing,
China, approved by the Independent Ethics Committee of participating
institutions. All study participants provided signed informed consent
and had the right to withdraw their consent at any time, without giving
reason and without detriment.