Study oversight
The study was designed by the authors in conjunction with the sponsor and conducted in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice. The study protocol and amendments were approved by the institutional review boards at participating sites. The study used an external data monitoring committee, which was responsible for ongoing safety monitoring during the study conduct as well as the prespecified interim futility and efficacy analyses. All patients provided written informed consent.