Long term, open label studies have shown that there are no particular safety concerns associated with 12 months treatment20. Long term placebo controlled study in patients 18-80 has demonstrated good safety profile in all ages49 56. It is however recommended to continuously monitor the efficacy and safety of Circadin® treatment irrespective of how long the patient is treated with Circadin®. The company received reports regarding patients that are treated with Circadin® for longer periods with good effect and no safety problems.
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