3.6. Intake of Study Product and Safety
ADVERSE EVENTS
Compliance was overall good in the study and in the ITT population; the mean intake of the LPHEAL9 product was 98.5%, while the mean intake was 99.0% for the placebo product during the 12 week intervention period. Thirty-nine adverse events were reported during the study, 20 in the LPHEAL9 group and 19 in the placebo group. Two adverse events were possibly related to the intake of LPHEAL9, and they were mild in intensity (a non-pathological increase in alanine aminotransferase levels). Thus, intake of LPHEAL9 was found to be safe and well tolerated.