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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\u2019s 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\u2019s study file.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"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\u2019 fees and honoraria from Merck Sharp & Dohme for lectures (\u20ac8.000); Carlos L. Errando received speakers\u2019 fees and honoraria for lectures from Merck Sharp & Dohme (\u20ac1.000); Blas Flor Lorente received speakers\u2019 fees and honoraria from Merck Sharp & Dohme for lectures (\u20ac3.000); Maria Pilar Argente Navarro received speakers\u2019 fees and honoraria for lectures from Merck Sharp & Dohme (\u20ac1.000); Guido Mazzinari, Nuria Garcia Gregorio, Maria Vila Monta\u00f1es, Daniel Robles Hernandez, Luis Enrique Olmedilla Arnal, Angel Mart\u00edn de Pablos, Anabel Marques Mar\u00ed and Marcus J. Schultz declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"190"}}