2.2. Intervention Protocol
epigastralgia, anxiety, tremor, epigastralgias, dizziness
ADVERSE EVENTS, ADVERSE EVENT, DISEASE, ADVERSE EFFECTS
Of the 67 eligible ME/CFS participants screened, two were excluded. The remaining 65 participants were allocated to treatment by an independent investigator not otherwise involved in the intervention, using a list of random numbers generated by a computer program. The participants were randomly assigned in a double-blind fashion in a 1:1 ratio to receive either active treatment (n = 35) or a matching placebo (n = 30) in the form of four capsules daily for nine months. They were instructed to ingest the capsules on an empty stomach, 30 minutes before breakfast and dinner, only with water. The intervention comprised the intake of a food supplement containing beta-glucan, vitamin D3, vitamin B6, and zinc. The placebo group received the same food supplement containing only microcrystalline cellulose instead of active ingredients.Safety information recorded at all study visits included data on adverse events, vital signs, and the results of the general physical examination. Adverse events, including serious ones, were reviewed throughout the trial by the independent medical monitor, the steering committee, and the independent data and safety monitoring board. Provision was made for investigator-initiated temporary or permanent dose reductions or suspensions due to adverse effects.During the study, nine subjects dropped out due to adverse events, specifically five in the intervention group (three epigastralgias, one dizziness, and one outbreak of the disease) and four in the placebo group (one epigastralgia, one tremor, and two anxiety episodes). Four patients were lost to follow-up (one in the intervention group and three in the placebo group). Finally, one patient in the placebo group was withdrawn at her own request. The remaining 51 cases of ME/CFS (78%, 22 in the placebo group and 29 in the intervention group) completed all the study protocol procedures and were included in the overall analysis of outcome measures as displayed in 