Gudiol, C. http://orcid.org/0000-0003-3095-4422
Nicolae, S.
Royo-Cebrecos, C.
Aguilar-Guisado, M.
Montero, I.
Martín-Gandul, C.
Perayre, M.
Berbel, D.
Encuentra, M.
Arnan, M.
Cisneros-Herreros, J. M.
Carratalà, J.
Funding for this research was provided by:
Instituto de Salud Carlos III, Spanish Ministry of Economy (PI13/01474)
Insituto de Salud Carlos III, Spanish Ministry of Economy (REIPI RD12/0015)
Bionet Medical S.L.
Article History
Received: 9 January 2018
Accepted: 13 April 2018
First Online: 2 May 2018
Ethics approval and consent to participate
: The protocol of the study was approved by the Research Ethics Committee at Hospital Universitari de Bellvitge (Ref. number AC019/13) and at Hospital Virgen del Rocío (Ref. number 2017-436-1).This study will be carried out in accordance with the protocol and principles established in the latest version of the Declaration of Helsinki, with respect to the standards of Good Clinical Practice CPMP/ICH/135/95, and in accordance with the Royal Decree of Clinical Trials 1090/2015, for which the clinical trials with medicine are regulated in Spain. It incorporates in its entirety the order of the European Directive 2001/20/EC, relative to the provisions of the member states on the application of Good Clinical Practice in conducting clinical trials of medicine for human use.The researchers agreed, when signing the protocol, to adhere to the instructions and procedures described in them and, in this way, to follow the principles of Good Clinical Practice that they imply.The data will be treated anonymously at all times, identifying each patient with a protocol number. The privacy and confidentiality of all data will be protected. The treatment, communication, and transfer of personal data of all patients will be in accordance with the Organic Law 15/13 December 1999.All participants will sign the informed consent. Before signing, all patients will be informed about the objectives of the study, the possible adverse reactions, the procedures to which they will be exposed, and the process of assignment of the intervention. Furthermore, they will be informed that their data will be treated with strict confidentiality.
: JMC has received travel grants and honoraria as a speaker from Astellas, Novartis, Pfizer, MSD, and AstraZeneca. MA-G received honoraria as a speaker from MSD. The other authors declared no conflicts of interest.
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