Ethics approval and consent to participate
Both studies were conducted in accordance with International Council for Harmonisation, Good Clinical Practice, the Declaration of Helsinki, the European Union Clinical Trials Directive 2001/20/EC, the GCP Directive 2005/28/EC, the requirements of local IEC/IRB, the US Code of Federal Regulations, Title 21 CFR Part 50, and the appropriate regulatory requirements in the countries where the studies were conducted. All patients provided informed consent in both studies.