Huang, Jingjing
Yu, Yimin
Jiang, Yi
Chen, Wu
Li, Yan
Shen, Yifeng
Zheng, Qingshan
Li, Huafang http://orcid.org/0000-0003-3965-969X
Funding for this research was provided by:
China National Major Project for IND (2018ZX09734-005)
Shanghai Clinical Research Center for Mental Health (19MC1911100)
Article History
Received: 20 March 2021
Accepted: 17 August 2021
First Online: 3 September 2021
Declarations
:
: The trial was approved by the Shanghai Mental Health Center Institutional Review Board (Central IRB, Approval No. 2019-39, No. 2019-39R1, IORG No. IORG0002202; FWA No. FWA00003065). All protocol amendments must be issued by the sponsor and signed by the investigator. Protocol amendments must not be implemented without IRB approval.The procedures comply with the local ethical regulations, the institutional regulations, and the Declaration of Helsinki (2013) and its amendments. The procedures also comply with the currently approved international codes and norms regarding the Good Clinical Practice in Clinical Investigation.Prior to enrollment, informed consent forms will be signed by each patient, as well as the investigator who provided the study information to the patient. Patients will be personally invited to participate when attending their regular visits to the outpatient clinic and will be informed about their freedom to withdraw consent at any time during the trial. The collection and processing of personal data from patients will be limited to those data that are necessary to fulfill the objectives of the study. These data will be collected with adequate precautions in place to ensure confidentiality and compliance with the applicable data privacy protection laws and regulations.All information supplied by the sponsor to the investigator and the data generated as a result of this trial are considered confidential and remain the property of the sponsor. The investigators agree to maintain the data in confidence and will not use it for any other purpose than to accomplish this study without the sponsor’s consent.
: Patients will be asked to consent to the use of their anonymized data in scientific publications. An informed consent form template has been developed, and this has been approved by the Shanghai Mental Health Center Institutional Review Board.
: The authors declare that they have no competing interests.