Ethics approval and consent to participate
Each subject was required to sign an informed consent form (ICF) to participate in the study. A legally authorized representative could have consented on behalf of a subject who was otherwise unable to provide informed consent, if acceptable to and approved by the site and/or the site’s institutional review board (IRB)/independent ethics committee (IEC). An ICF that explained the procedures of the study, including the potential hazards, was reviewed and approved by the IRB/IEC before its use. The ICF was read by and explained to each subject or their legally authorized representative before entering the study. Each subject had ample opportunity to ask questions and was assured of the right to withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Each subject or representative received a signed and dated copy of the ICF. The study was conducted in accordance with the Declaration of Helsinki.