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The study protocol was approved by the Research Ethics Committee of Hcor (Approval No. 3.025.156), as well as by the local Research Ethics Committees of the participating centers, when applicable. The parent clinical trial was registered at ClinicalTrials.gov (NCT01620398). Written informed consent was obtained from all participants prior to enrollment in the study.","order":2,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Ethics"}}]}}