Ethics approval and consent to participate
ICH
An independent ethics committee or institutional review board at each study center reviewed and approved all relevant documents including the study protocol, all study protocol amendments, written study patient information, informed consent form, and Investigator’s Brochure before patients were enrolled. This study was conducted in accordance with the protocol and international ethical principles from the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable ICH, GCP, applicable regulations, and other guidelines and applicable laws and regulations. All patients provided written informed consent before study entry.