8. What is the effect of DONA™ on the signs and symptoms of osteoarthritis?

Short-term (up to 6 months), randomised, controlled clinical studies in osteoarthritis have shown that, already within the first 2 weeks of treatment, DONA™ induces improvement in pain and function which is of the same magnitude of that obtained with non-steroidal-antiinflammatory drugs (NSAIDs) up to 4 weeks.

Thereafter, the improvement with DONA™ continues in a linear fashion and tends to be greater than that of NSAIDs, till the completion of a 12-week treatment course, that can be considered the optimal short-term treatment duration with DONA™. Indeed, the clinical improvement is strong and long-lasting, i.e. for at least 2 months after the end of such a 12-week treatment course. Long-term (up to 3 years), randomised, placebo-controlled studies have shown that the significant improvement on osteoarthritis pain and function can be similarly obtained over chronic treatment courses, using either cyclic or continuous administration regimens.

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