5.1. Standard Protocol Approvals, Registrations, and Patient Consents

The trial was conducted at 24 clinical sites across the USA and in accordance with the ethical principles originating from the Declaration of Helsinki and current Good Clinical Practices and in compliance with local regulatory requirements and 21 CFR 312. The study protocol was approved by the local institutional review board or independent ethics committee at each participating site. Informed consent was obtained from all patients prior to screening. The study was registered at ClinicalTrials.gov (Identifier {"type":"clinical-trial","attrs":{"text":"NCT01655823","term_id":"NCT01655823"}}NCT01655823).