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Article History

Received: 30 January 2020

Accepted: 14 August 2020

First Online: 31 August 2020

Ethics approval and consent to participate {24}

: This study will be carried out strictly respecting the ethical principles of biomedical research and current legislation in Spain. All personnel participating in this study agree to follow, during the performance of the study, the Standards of Good Clinical Practice (Guideline for good clinical practice E6 R2: ).The approval of the Clinical Research Ethics Committees (CREC) of the participating centers will be obtained and documented, as well as the approval of the Spanish Agency for Medicines and Health Products before starting the study. The local approvals corresponding to the participating centers will be obtained and documented before starting the study in the centers. The responsible researcher of each center will be the interlocutor of the CREC corresponding to its center in everything related to the present study. It will keep the CREC informed of the evolution of the study in the center and of the possible incidents and minor modifications that may occur. Any relevant modification to the protocol after its approval must receive express approval from the reference CREC and the Spanish Agency for Medicines and Health Products before its implementation, unless there are risk circumstances for the participating subjects; in which case, they will be implemented with the precise measures to ensure the integrity of the patients immediately awaiting the corresponding approvals.A signed informed consent will be obtained from all study participants before any study-related procedures are undertaken.

: Not applicable.

: The authors declare that they have no competing interests.