Article History
Received: 20 October 2021
Accepted: 6 December 2021
First Online: 20 January 2022
Declarations
:
: None of the authors have any commercial interests in the subject of study or sources of any financial or material support to disclose.
: L. Vidal is an employee of Fidia Farmaceutica S.L.U. All the authors state that Fidia Farmaceutica S.L.U. did not solicit this research project or any protocols through research investigators or institutes. Fidia Farmaceutica S.L.U. was not responsible for initiating the study and did not participate in the scientific design of the trial, creation of the protocol, study management, data analysis, reporting, or the decision to submit the manuscript for publication. The study protocol and its amendments were approved by the Ethics Committee at the Hospital La Fe research institute, and each patient provided their express written informed consent to participation. The trial was performed in accordance with the Declaration of Helsinki and Good Clinical Practices guidelines (trial registration: EudraCT: 2016-003952-63).