Study design
The GAUDI study was a randomized, multicenter, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish centers in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital Universitario La Paz (Madrid, Spain) approved this study. All patients gave their written informed consent.The study duration per patient was up to 24 weeks consisting of a screening period, a treatment period with monthly visits from the start of the study until week 12, and a last follow-up visit on week 24 conducted by telephone call (Fig. GAUDI Study design diagramFor the treatment period, participants were instructed to take two 500 mg softgels of SPMs enriched oil (SPMs group) or olive oil placebo (placebo group) after breakfast and two 500 mg softgels after dinner for a total of four softgels of SPMs or placebo per day during the first 6 weeks of the study. During the last 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner for a total of two softgels of SPMs or placebo per day. Thus, the treatment period lasted in total 12 weeks per patient.