Tuca Rodríguez, Albert http://orcid.org/0000-0002-4633-5856
Núñez Viejo, Miguel http://orcid.org/0000-0001-6361-2133
Maradey, Pablo
Canal-Sotelo, Jaume http://orcid.org/0000-0002-9150-5228
Guardia Mancilla, Plácido http://orcid.org/0000-0002-2629-7522
Gutiérrez Rivero, Sonia
Raja Casillas, Inmaculada
Herrera Abián, María
López Bermudo, Cristina http://orcid.org/0000-0002-9354-6859
Funding for this research was provided by:
Angelini Farmacéutica, SA. (Not applicable)
Article History
Received: 1 April 2020
Accepted: 19 January 2021
First Online: 3 February 2021
Change Date: 6 February 2021
Change Type: Update
Change Details: The update is due to incorrect tagging of family name in the xml.
Declarations
:
: This study was classified by the Spanish Agency of Medicines and Medical Devices (AEMPS) as an observational post-authorization study with prospective follow-up (EPA-SP). All procedures were performed according to the legislation for this study type. The study was conducted according to the Declaration of Helsinki, the Data Protection Directive, and any local requirements. The protocol, patient information sheet, and informed consent for the study were approved by the Galician Research Ethics Committee (Register Code: 2016/214; March 30, 2016) and afterwards by the research ethics committees of the participating centers. In addition, patients were identified with numbers to warrant anonymity. All patients included in the study gave their written informed consent at V0 before data collection.
: Not applicable.
: ATR received honoraria from Angelini Pharma España S.L.U., for serving as a research advisor. CLB received a salary from Angelini Pharma España S.L.U. The other authors declare no conflict of interest related to this article.