ETHICS STATEMENT
ICH
This study was approved by an Independent Ethics Committee or Institutional Review Board. Each participating patient provided informed consent. This study (including the informed consent process) was conducted according to the ethical principles stated in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), applicable International Council for Harmonization (ICH) Good Clinical Practice Guidelines (CPMP/ICH/135/95), and the applicable drug and data protection laws and regulations of the countries where the clinical study was conducted. Clinical trial registration number: NCT03329911.