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Safety of Simtriyo was studied over 52 weeks in adults8
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Open-label extension study design
- Primary endpoint: Long-term safety and tolerability of Simtriyo,‡ administered twice daily
- Patients had either rolled over from 1 of 2 previously conducted randomized, double-blind, placebo-controlled phase 3 pivotal trials or were enrolled de novo8
- Exploratory efficacy was assessed using the AISRS and the CGI-S8
‡There are no expected differences in effectiveness of the low and high doses of the adult study formulation compared to Simtriyo 210 mg and 280 mg once daily, respectively, for the treatment of ADHD.[br-d]AISRS=Adult ADHD Investigator Symptom Rating Scale; BL=baseline.
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