2.4. Study Design and Procedures
The trial was a 36-week long, single-center, randomized, double-blind, placebo-controlled study. Clinical visits and trial design of both groups are detailed in Patients were evaluated at baseline, at a 16-week follow-up (safety) visit, and then at a 36-week visit by the site investigator. Changes in symptoms were assessed through validated self-report questionnaires completed by participants under the supervision of two trained investigators (J.C.-M. and J.A.). Compliance was checked through medication logs. The use of concomitant medications was tracked at the 36-week visit. The study protocol was reviewed and approved by the local IRB at the participating site (Clinical Research Ethics Committee, Vall d’Hebron University Hospital, Barcelona, Spain, under protocol reference InmunoVitaME-PR(AG)-447-2019, approved on 28 February 2019).The study protocol was conducted in accordance with the guidelines of the Declaration of Helsinki, the current Spanish regulations on clinical research, and the standards of good clinical practice of the European Union. It also followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The current clinical trial was registered on 