Confidentiality {27}
All patient data collected will be managed by the sponsor to ensure the confidentiality of those data, and in accordance with applicable national laws and regulations on personal data protection, and the study will perform in accordance with WHO guidelines for Good Clinical Practice. The case report form will be stored safely, and the study data will be recorded with REDCap, on the intrahospital server at H.U.D.E.R.F.