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Article History

Received: 14 July 2020

Accepted: 16 July 2020

First Online: 29 July 2020

Ethics approval and consent to participate

: This clinical trial has received ethical and regulatory approvals from the appropriate ethical and regulatory committees in order to safeguard the health of the participants. It was first approved by the Hospital Clinic’s Drug Research Ethics Committee (CEIm) with date April 2^nd 2020 and the Spanish Agency of Medicines and Medical Products (AEMPS) with date April 3^rd 2020. The last protocol amendment was approved June 9^th 2020 with AEMPS reference number PGFPP7W635.Participation in this study is voluntary, and under no circumstances the clinical management of participants will be affected by their decision to participate or not in the study. Informed consent will be signed by all participants before their inclusion in the study. The study consent form reflects the risks and benefits of participating in the study, and the specific sampling procedures to be done to each participant. Sufficient time will be given to the participant’s guardians to decide whether or not to participate in the study. Candidates will be given the opportunity to enquire about the details of the study and any question regarding the study will be answered.

: Not applicable

: The authors declare that they have no competing interests.