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The study was approved by a central committee, the Clinical Research Ethics Committee of the Dr. Josep Trueta University Hospital in Girona (Spain), by the Ethics Committees of the participating centers, and by the Spanish Agency Medicines and Health Products (AEMPS in the Spanish acronym). The study was also registered in clinicaltrials.gov (Identifier: NCT04740242). An informed consent was obtained from all participating subjects.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}