Ethics approval
DEL
The study was designed in agreement with the Declaration of Helsinki/Tokyo. All procedures involving human subjects were approved by Clinical Research Ethics Committee of the Jordi Gol University Institute for Primary Care Research (Institut d’ Investigació en Atenció Primària; IDIAP), the Pere Virgili Health Research Institute (Institut d’Investigació Sanitària Pere Virgili; IISPV), and of the Spanish Agency for Medicines and Medical Devices (Agencia Española del Medicamento y Productos Sanitarios; AEMPS).