Pedrós, Consuelo
,
Ávila, Mónica http://orcid.org/0000-0001-9583-5104
Gómez-Lumbreras, Ainhoa
Manríquez, Marcela
Morros, Rosa
Funding for this research was provided by:
Instituto de Salud Carlos III (PI15/00764)
Article History
Received: 26 February 2019
Accepted: 16 May 2019
First Online: 30 May 2019
Ethics approval and consent to participate
: The study protocol was approved by the CRECs of all participant centres (study code in the coordinating centre [Bellvitge University Hospital] CREC: EPA032/16; [Hospital Germans Trias i Pujol] CREC: PI-16-120; [Hospital Clinic of Barcelona] CREC: HCB/2019/0528; [University Hospital Vall d’Hebron] CREC: EPA (AG)55/2016(4967); [Hospital de la Santa Creu i Sant Pau] CREC: 16/156(OBS); [Ramón y Cajal University Hospital] CREC: ALIMAR-C2; [Fundación Jiménez Díaz University Hospital] CREC: EOH 2016–37; [Hospital Clínico San Carlos] CREC: 16/326-E; [Institut Universitari d’Investigació en Atenció Primària (IDIAP) Jordi Gol] CREC: P16/105, and [Gerencia Asistencial de Atención Primaria] CREC:43/16. All CRECs accepted a waiver for participant consent, taking into account the characteristics of the study.The ALIMAR-C2 study was registered onto the European Union electronic Register of Post-authorisation Studies (EU PAS Register Number: EUPAS13969, June 2016) and received the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) seal (ExternalRef removed).Regarding the data contained in the databases and according to Spanish legislation about confidentiality and data protection (Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales), data included in this study consist of the identification of incident cases of LA in hospitals and some specific information from primary care. In order to link this information, the same identity code is needed for the patients. A codification system will be performed to conduct this linking process maintaining the anonymization of the patients.
: Not applicable.
: The authors declare that they have no competing interests.
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