Ethical Conduct
ADVERSE EVENTS, EVENTS
The protocol met regulatory guidelines governing clinical development of investigational devices and was approved by the medical center’s Ethics Committee. Investigators were required to notify the Ethics Committee of safety events according to the local requirements. All adverse events (AEs) and serious AEs (SAEs) were reviewed by an independent data and safety monitoring board (DSMB) through study end. In accord with the Helsinki Declaration and ISO14155 regulations, 21 CFR Good Clinical Practices, patients’ safety, and well-being were protected.