Funding for this research was provided by:
the Carlos III Health Institute (Grant PI16/02130)
the SCReN-Spanish Clinical Research Network, (PT13/0002/0031)
Received: 26 March 2018
Accepted: 3 September 2018
First Online: 24 September 2018
Ethics approval and consent to participate
: This trial obtained full approval from the University Clinical Hospital Ethics Committee (CEIC-HCUV) and from the Spanish Agency for Medication and Health Products (AEMPS). GPs will give the information sheet and the informed consent form to each patient, responding to all queries and concerns. All patients voluntarily accepting to participate will provide the corresponding informed consent signed.Important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) will be communicated to the different involved parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators), depending on the relevance.
: Not applicable.
: The authors declare that they have no competing interests.
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