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Article History

Received: 24 August 2020

Accepted: 24 October 2020

First Online: 4 November 2020

Ethics approval and consent to participate

: The original clinical study (Protocol version 1.1; date May 6, 2019) and an amendment to include optional telematic follow-up in the pandemic COVID-19 scenario (Protocol version 1.2; date 24/06/2020) have been approved by the Ethics Committee for Clinical Research at the La Paz University Hospital and ratified by the Ethics Committees of all the participating hospitals. The study was registered on June 27, 2019 at (NCT 04001049). Recruitment started on June 30, 2020 and it is currently ongoing. All the patients will be asked to sign a written informed consent form after a detailed explanation of the nature and purpose of this study and before undergoing any of the procedures related to the study. In the case of patients with impaired consciousness, aphasia or neglect that could limit the understanding of the study objective and procedures, the signature of the patient´s guardian or legal representative will be acceptable.The experimental animal model study was approved by the Ethics Committee for research in animals at the La Paz University Hospital and authorized by the Madrid Regional Government.

: Not applicable.

: The authors declare that they have no competing interests.