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The patients were examined every three months during the extension phase. Countries, including investigator recorded spontaneously reported adverse events and assessed need for additional PD therapy. Azilec well tolerated with 11.3 % withdrawing due to to an adverse event. The most common adverse were in this study were infection, headache, nausea, dizziness, accidental injury and joint pain. Patients who withdrew due to to an adverse event as likely to Azilec monotherapy as Azilec combination therapy .

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