Molló, Àngels
Berenguera, Anna
Rubinat, Esther
Vlacho, Bogdan
Mata, Manel
Franch, Josep
Bolíbar, Bonaventura
Mauricio, Dídac
Funding for this research was provided by:
The study is partially supported by an unrestricted grant from Sanofi. The study has also intramural support from Institut Universitari d’Investigació en Atenció Primària Jordi Gol.
Article History
Received: 17 January 2017
Accepted: 29 January 2019
First Online: 7 February 2019
Ethics approval and consent to participate
: The study will be conducted according to the Helsinki Declaration and Good Clinical Practice guidelines. The study protocol was approved by the Ethics Committee of IDIAP Jordi Gol, Institute of Research in Primary Health Care. Trial Registration Number: P14/129.The study was registered in the ExternalRef removed registry under clinical trial registration number: NCT02663245; January 25, 2016.Reporting of this trial will adhere to the most relevant and up-to-date CONSORT statement [CitationRef removed] and its relevant extensions [CitationRef removed]. The results from this study will be published regardless of the outcomes.Confidentiality and anonymity of the data will be ensured according to Law 15/1999 of data confidentiality, both in the implementation phase of the project and in the resulting presentations and/or publications. Individual data will be codified to ensure anonymity. Only researchers and monitors will have access to the data.Summary of the informed consent procedureWe used the final study protocol to prepare the patient information sheet (PIS) and the written informed consent form (ICF) in accordance with the current Spanish applicable legislation. The PIS included all the procedures, visits, risks and inconveniences for the participant in the study. A properly qualified site investigator provided the information to the potential study participants during a personal interview prior to the subject’s inclusion and before performing any procedures of the study. During the interview, all subjects had an adequate period of time to reflect before making the decision to participate in the study, and had the opportunity to ask any questions or concerns about the study procedures. Once they agreed to participate, each study subject signed and dated the ICF, and included information regarding the complete name of the investigator and the date of the interview. All the procedures of informed consent acquirement were adequately reflected in the patient’s clinical history.
: Not applicable.
: The authors declare that do not have any conflict of interest.
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