There were a total of 10 serious adverse events (SAE)
recorded over the study period: six in the placebo group and
four in the chitosan group (P¼0.53, Table 4). The SAE were
defined as hospitalisations (three in the chitosan group, four
in the placebo group, P¼0.71), cancer incidence (one in the
chitosan group, three in the placebo group, P¼0.34) and
one death (placebo group). Of the nonserious adverse events,
36 volunteers in the chitosan group and 19 in the placebo
group reported noninfectious gastrointestinal side effects
(defined as abdominal pain, bloating, constipation, indigestion,
or non-infectious diarrhoea) (P¼0.02). There were no
significant differences between intervention groups in any
other category of nonserious adverse events.