11. What may be the few and mild adverse reactions of DONA™?

Transient and mild adverse events, may include gastric discomfort and pain, constipation, diarrhoea, meteorism and nausea. Since the proportion of these events is low and similar to the one observed with placebo in comparative clinical studies, these events may be related to the mild discomfort that may be evident with any oral drug intake in some patients. Indeed, the incidence of these adverse events is much, significantly, lower than with conventional NSAIDs and without any of the gastrointestinal complications of the latter. Hypersensitivity reactions were reported in some patients and included cutaneous rashes with pruritus and erythema. Very rarely and most likely without any relationship with DONA™ administration, headache, visual disorders and hair loss have been reported.

These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.