In order to further characterise the long-term safety and tolerability of cariprazine, the 6-week efficacy trials were continued into one-arm open-label extension studies of cariprazine therapy for up to 48 weeks of cariprazine therapy (Table 3). The 679 patients treated on average for 188 days provided safety data of 350 patient-years of cariprazine exposure. These results support the safety and tolerability of cariprazine within the dose range of 1.5–6 mg/day approved by both the FDA and EMA for the treatment of schizophrenia.

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