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This study was approved by the Ethics Committee (Comit d'tica de la Investigaci Clnica CEIC, Germans Trias i Pujol University Hospital, coordinator centre), and was conducted in agreement with the Declaration of Helsinki, Organic Law 15/1999 of 13 December about the protection of personal data, Law 14/2007 of 3 July on Biomedical Research, and Guideline for Good Clinical Practice of 2016