Institutional Review Board Statement
All study procedures were reviewed and approved by the local Clinical Research Ethics Committee of the Vall d’Hebron University Hospital in Barcelona, Spain (protocol code: InmunoVitaME-PR(AG)-447-2019; approved on 28 February 2019). The study was conducted in accordance with the guidelines of the Declaration of Helsinki, the current Spanish regulations on clinical research, and the EU’s standards of Good Clinical Practice. It also followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines.