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The protocol was authorized by the Ethics Committee (CEIm Provincial de Sevilla) and the Spanish Regulatory Agency (AEMPS) on the 18 February 2019. Patient data were processed in compliance with European Union General Data Protection Regulation 2016\/679 and Spanish Organic Law 3\/2018 on the Protection of Personal Data and Guarantee of Digital Rights.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics and Regulatory Agency Approvals"}},{"value":"Written informed consent was obtained from all participants prior to enrolment.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"Conceived the idea: Antonio Carrillo-Vico and Patricia Judith Lardone. Data collection: Silvia Jim\u00e9nez-Jorge, Mar\u00eda \u00c1ngeles Lobo-Acosta, Roc\u00edo L\u00f3pez-Ruiz and Sara Eichau. Data Analysis: Silvia Jim\u00e9nez-Jorge, Ana Isabel \u00c1lvarez-L\u00f3pez, Eduardo Ponce-Espa\u00f1a. Pharmacovigilance: Mar\u00eda \u00c1ngeles Lobo-Acosta, Clara M Rosso- Fern\u00e1ndez. Clinical review of patients: Mar\u00eda \u00c1ngeles Lobo-Acosta, Javier Ampuero, Manuel Romero-G\u00f3mez, Clara M Rosso- Fern\u00e1ndez. Drafting of the manuscript: Ignacio Bejarano and Patricia Judith Lardone. Obtained funding: Patricia Judith Lardone, Clara Mar\u00eda Rosso-Fern\u00e1ndez, Juan Luis Ruiz-Pe\u00f1a and Antonio Carrillo-Vico. Administrative and technical support: Mar\u00eda \u00c1ngeles G\u00e9niz, Mar\u00eda Isabel Garc\u00eda-S\u00e1nchez, Manuel Came\u00e1n, Vicente Merino-Bohorquez, Silvia Jim\u00e9nez-Jorge, Mar\u00eda \u00c1ngeles Lobo-Acosta and Guillermo Izquierdo. Critical revision of the manuscript: Patricia Judith Lardone, Antonio Carrillo-Vico, Ignacio Bejarano, Silvia Jim\u00e9nez-Jorge, Roc\u00edo L\u00f3pez- Ruiz, Sara Eichau, Juan Miguel Guerrero, Javier Ampuero, Manuel Romero-G\u00f3mez, Mar\u00eda \u00c1ngeles Lobo-Acosta, Clara Mar\u00eda Rosso-Fern\u00e1ndez. Approval of the manuscript: all authors.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}