Ethical conduct of the study
ICH
This study was conducted in accordance with the accepted version of the Declaration of Helsinki, United States Food and Drug Administration (FDA) Law, the European Union (EU) Clinical Trials Directive 2001/20/EC, in compliance with International Council for Harmonization (ICH) good clinical practice (GCP) E6 R2 guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted.