Soler, Aina
Amer, Guillem
Leiva, Alicia
Ripoll, Joana
Llorente, María Angeles
Leiva, Alfonso
Taltavull, Joana Maria
Molina, Rosa
Llobera, Joan
Funding for this research was provided by:
Instituto de Salud Carlos III (PI 16/0720)
Article History
Received: 11 December 2018
Accepted: 27 March 2019
First Online: 11 April 2019
Ethics approval and consent to participate
: This study will follow the principles outlined in the Declaration of Helsinki (with the Tokyo 2004 amendment). All legal caregivers and patient when appropriate will provide written informed consent, and will be told that participation is voluntary and can be withdrawn at any time without any negative consequences concerning current or future medical treatments. Ethical approval was provided by the Primary Care Research Commission (PI16/025), the Institutional Review Board of the Balearic Islands Health Service (CEI-IB Ref. No: PI16/720), and the Spanish Agency on Drugs and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) (EudraCT number 2017–000042-22). Approved protocol version 2.0 (02/11/ 2016).Any protocol amendments will be notified to Institutional Review Board of the Balearic Islands Health Service and Spanish Agency on Drugs and Medical Devices.
: Not Applicable.
: The authors declare that they have no competing interests.
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