Ethical aspects and confidentiality
The protocol will be approved by the ethical committee of each participating hospital as well as that of the coordinating centre. The study researchers will carry out their tasks in compliance with ethical principles of clinical research established in the Declaration of Helsinki, and with the rules of Good Clinical Practices. It is planned to hire a policy to cover the concepts and compensations according to article 69 of Regulation (EU) 2017/745 and the current national legislation regulating clinical investigation with healthcare products. Before inclusion of the patient in the trial, written informed consent will be requested. In relation to the study data, we will follow the provisions of Law 3/2018 on Personal Data Protection and guarantee of digital rights and, additionally, the General Data Protection Regulation (EU) 2016/679. Important protocol modifications (e.g. changes to eligibility criteria, outcomes, analyses) will be communicated to relevant parties after being reviewed by the ethical committee of the coordinating centre. The final trial dataset will be accessible only by the promotor, steering committee, data manager, and statistician.