1. Spanish Agency for Medicines and Medical Devices (AEMPS), Department of Medicines for Human Use, Pharmacoepidemiology and Pharmacovigilance Unit, Madrid, Spain

2. Servicio Aragonés de Salud (SALUD); EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón; Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Zaragoza, Spain