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placebo + asenapine refers to a specific treatment sequence used in the Phase IIIB extension study (Protocol P05689, NCT01617200) for schizophrenia. In this arm, patients who were initially randomized to receive a placebo during a 6-week parent trial (Protocol P05688) were transitioned to receive sublingual asenapine maleate (brand name Saphris) at a dose of 2.5 mg twice daily for a 26-week extension period. Asenapine is an atypical antipsychotic that acts as an antagonist at multiple neurotransmitter receptors, including dopamine D2 and serotonin 5-HT2A receptors. The study, sponsored by Forest Laboratories, aimed to evaluate the long-term safety and tolerability of asenapine compared to an active control (olanzapine) in patients with schizophrenia.
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