Ethical considerations
The Research Committee of Hospital Son Llàtzer and the Balearic Islands Research Ethics Committee [CEI-IB] (IB1933/12 PI) approved the study design. Before participating, all patients provided written informed permission. All tests were carried out in conformity with the applicable standards and regulations. EudraCT no. 2017-003609-16, which was validated on February 22, 2018, is the clinical trial number. U1111-1201-5736 is the Universal Trial Number (UTN). Other earlier clinical study outcomes have previously been published [