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Article History

Received: 19 December 2020

Accepted: 23 December 2020

First Online: 11 January 2021

Ethics approval and consent to participate

: This clinical trial will be carried out in accordance with the ethical principles of the most recent revision of the Declaration of Helsinki and current legislation. The original and revised versions of the protocol, information sheet and informed consent form have been approved by the clinical research ethics committee (CREC) of University Hospital La Princesa and the Spanish Agency of Medicines and Medical Devices (AEMPS) (approval of the latest version being granted on 28 August 2020, reference number: 17092020_08400, locator: QFSS36Q6C5). For further information, the following link to the public listing of the ethical approval is available: . The researchers certify that this trial has received ethical approval from the appropriate ethical committee as described above.The researchers will be in charge of providing each patient or their legal representative with the patient information sheet and informed consent form. Individuals participating in the trial or their legal representative will be asked to sign and date the informed consent form prior to inclusion in the study, that is, before the performance of any intervention.

: Not applicable.

: The authors declare that they have no competing interests.