Ethics approval
ICH
This study was conducted in full conformance with the International Council for Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or with the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. The protocol, the informed consent forms, and any accompanying material provided to patients were submitted to the independent ethics committee (IEC) by the Principal Investigator and reviewed and approved before the study was initiated. A full list of the IECs at participating institutions is provided with the primary analysis [