Standard Protocol Approvals, Registrations, and Patient Consents
POLAND
The registry was conducted in accordance with the Declaration of Helsinki and regulations of the country in which the registry was conducted, including data protection laws. Ethics committee approval was obtained at each center, except in Poland, where ethics committee approval was not needed according to local laws and regulations. All participants granted ethics committee/institutional review board–approved and informed consent/data release consent. The trial was registered on January 31, 2012, at ClinicalTrials.gov (NCT01521754).