3.2. Clinical Trial Design
allergies
ADVERSE REACTIONS, SECONDARY, ALLERGIES
The study flow chart, produced in accordance with the CONSORT PRO reporting guidelines [The two groups consisted of 58 subjects, including 22 males (corresponding to 38%, 12 of which were allocated to Group 1) and 36 females (corresponding to 62%, 17 of which were allocated to Group 1); both groups were administrated daily for 2 months, according to the parallel group design. Group 1 was initially treated with the placebo while Group 2 was treated with the food supplement. The participants from each group had similar sociodemographic characteristics and clinical data with no significant differences. The baseline characteristics of the subjects of each group are summarized in The LMM model used for the FSS questionnaire (Regarding the SF-12 questionnaire, the LMM model (Concerning the secondary outcomes, the LMM models applied to the biochemical markers did not show any differential effect of treatment on the response of the variables between the two measurements (t0 and t2, see Finally, during the three months of treatment, no subjects reported adverse reactions related to the administration of the food supplement, including the absence of allergies, and the principal investigator judged that this food supplement could be considered well tolerated.