Funding for this research was provided by:
Merck Investigator Studies Program Review Committee (MISP-RC), Merck Sharp & Dohme (protocol code #53607 with $109,672)
Text and Data Mining valid from 2019-04-03
Received: 30 July 2018
Accepted: 27 February 2019
First Online: 3 April 2019
Change Date: 13 January 2020
Change Type: Correction
Change Details: After publication of our article  the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.
Ethics approval and consent to participate
: The study will be carried out according to a protocol reviewed and approved at a national level by the Institutional Review Board (IRB) of Hospital Universitari i Politècnic La Fe, Valencia, Spain, and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The study has been registered at ClinicalTrials.gov (identifier NCT02773173, May 16, 2016) and EudraCT (2016-001693-15), and is conducted in accordance with the Declaration of Helsinki on ethical principles for medical research in human subjects, adopted by the General Assembly of the World Medical Association (1996). Data management, monitoring and reporting of the study are performed in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines (ICH) (CPMP/ICH/135/95) and the regulatory requirements for participating institutions by the Spanish Clinical Research Network (SCReN). Investigators collect a written informed consent form in compliance with the GCP recommendations to the patient or his/her legal representative if the patient’s clinical conditions do not allow him/her to review and approve it. Investigators provide a copy of the signed informed consent form to each subject and keep a copy in the subject’s study file.
: Not applicable.
: Oscar Diaz-Cambronero received a grant from the Merck Investigator Studies Program Review Committee (MISP-RC), Merck Sharp & Dohme, protocol code #53607 with $109,672 and speakers’ fees and honoraria from Merck Sharp & Dohme for lectures (€8.000); Carlos L. Errando received speakers’ fees and honoraria for lectures from Merck Sharp & Dohme (€1.000); Blas Flor Lorente received speakers’ fees and honoraria from Merck Sharp & Dohme for lectures (€3.000); Maria Pilar Argente Navarro received speakers’ fees and honoraria for lectures from Merck Sharp & Dohme (€1.000); Guido Mazzinari, Nuria Garcia Gregorio, Maria Vila Montañes, Daniel Robles Hernandez, Luis Enrique Olmedilla Arnal, Angel Martín de Pablos, Anabel Marques Marí and Marcus J. Schultz declare that they have no competing interests.
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