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Data and Safety monitoring
An independent Data and Safety Monitoring Board (DSMB) will be established to monitor the progress of the study and ensure that the safety of subjects enrolled in the study is not compromised. Details of the composition, meetings, roles, responsibilities, and processes of the DSMB are documented in the DSMB charter. The independent DSMB will review safety data main outcomes at regular intervals. Reports and recommendations (continue, amend or stop the study based on findings) will be reported to the Project Coordinator, who is responsible for informing the General Assembly.
