Ethics approval and consent to participate: All patients gave their informed consent to participate. The study centers assigned each participant an identification code in order to ensure data confidentiality in line with current legislation. The study complies with the Declaration of Helsinki and was approved by the Clinical Research Ethics Committees of the Principality of Asturias (study number 14/2014).
Consent for publication: Not applicable.
Availability of data and materials: The datasets generated and analysed during the current study are available from [email protected] on reasonable request.
Competing interests: The authors declare that they have no competing interests related to this work.
Funding: This work was supported by AbbVie, that had no role in the design, data collection, data analysis, interpretation, writing or the decision to submit the paper for publication of this manuscript.
Authors´ contributions: RQ participated in the design of the work, the acquisition and interpretation of data, and was a major contributor in writing the manuscript. DS participated in the design of the work, the analysis and interpretation of data, and was a major contributor in writing the manuscript. EGA and AL made substantial contributions to the acquisition of data. JC, JG, XJ and JF participated in the design of the work. AGM participated in the analysis of data. All authors revised the manuscript critically, and read and approved the final version.
Acknowledgements: The authors would like to acknowledge José Luis Fernández Sueiro for the conception of the study; José Miguel Carrasco for his contribution to the design of the study; Nuria Montero and Cristina Oliva for their contribution to data monitoring; Ana Serrano and Cristina Pruenza for their contribution to data analysis; and Thomas O´Boyle for the translation of the manuscript.
Non-author members of REAPSER Study Group: Jesús Rodriguez-Moreno, Jaime Notario Rosa (Hospital Universitari de Bellvitge, Barcelona, Spain); Andrés Lorenzo Martín, Anahy Brandy García, Pablo Coto Segura (Hospital Universitario Central de Asturias, Oviedo, Spain); Hye-Sang Park, Anna López Ferrer (Hospital de la Santa Creu i Sant Pau, Barcelona, Spain); Silvia Pérez Barrio (Hospital Universitario Basurto, Bilbao, Spain); Carlos Montilla, Andrés J Plata Izquierdo (Hospital Clínico Universitario de Salamanca, Salamanca, Spain); Juan J. Bethencourt Baute, Sagrario Bustabad, Francisco J Guimerá Martín-Neda (Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain); Jose A. Pinto-Tasende, Eduardo Fonseca Capdevilla (Complexo Hospitalario Universitario A Coruña, A Coruña, Spain); Beatriz Joven Ibáñez, Raquel Rivera Díaz (Hospital Universitario 12 Octubre, Madrid, Spain); Julio Ramírez, Andrea Cuervo, Mercè Alsina Gibert (Hospital Clinic i Provincial, Barcelona, Spain); Pilar Trenor Larraz, Isabel de la Morena Barrio, Laura Puchades Lanza, Diego Bedoya Sanchís (Hospital Clínico Universitario de Valencia, Valencia, Spain); Elide Toniolo, Catalina Meliá Mesquida, Claudia Murillo (Hospital Son Llàtzer, Palma de Mallorca, Spain); Manuel J Moreno Ramos, María D Beteta, Paloma Sánchez-Pedreño Guillén (Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain); Leticia Lojo Oliveira, Teresa Navío Marco, Laura Cebrián, Pablo de la Cueva Dobao (Hospital Universitario Infanta Leonor, Madrid, Spain); Martina Steiner, Santiago Muñoz-Fernández, Ricardo Valverde Garrido (Hospital Universitario Infanta Sofía, Madrid, Spain); Manuel León, Esteban Rubio, Alejandro Muñoz Jiménez, Lourdes Rodríguez Fernández-Freire (Hospital Universitario Virgen del Rocío, Sevilla, Spain); Julio Medina Luezas, María D Sánchez-González, Carolina Sanz Muñoz (Hospital Clínico Universitario de Valladolid, Valladolid, Spain); José M Senabre, José C Rosas, Gregorio Santos Soler, Francisco J Mataix Díaz (Hospital Marina Baixa, Villajoyosa, Spain); Juan C Nieto-González, Carlos González, Juan G Ovalles Bonilla, Ofelia Baniandrés Rodríguez (Hospital Universitario Gregorio Marañón, Madrid, Spain); Fco Javier Nóvoa Medina, Dunia Luján (Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria, Spain); María D Ruiz Montesino, Ana M Carrizosa Esquivel (Hospital Universitario Virgen Macarena, Sevilla, Spain); Cristina Fernández-Carballido, María P Martínez-Vidal, Laura García Fernández (Hospital General Universitario de Elda, Elda, Spain); Vega Jovani, Rocío Caño Alameda, Silvia Gómez Sabater, Isabel Belinchón Romero (Hospital General Universitario de Alicante, Alicante, Spain); Ana Urruticoechea-Arana, Marta Serra Torres (Hospital Can Misses, Ibiza, Spain); Raquel Almodóvar, José L López Estebaranz (Hospital Universitario Fundación Alcorcón, Alcorcón, Spain); María D López Montilla, Antonio Vélez García-Nieto (Hospital Universitario Reina Sofía, Córdoba, Spain) collected data.