2.5. Safety Assessment
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
All participants were monitored for adverse events and side effects throughout the 24-week intervention period and 1-week post-observation period. Safety monitoring included a questionnaire on general health and the occurrence of any health-related events. The severity of adverse events was evaluated according to the Common Terminology Criteria for Adverse Events version 4.0 JCOG/JSCO. The number of events and the incidence of occurrences were calculated for each group. The relationships between adverse events and intake of the test food were evaluated by the principal investigator.