By virtue of its definition.

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CONCLUSIONS In this trial, PBA episodes had been frequent and severe at baseline in individuals with underlying ALS. Both Zenvia 30/10 mg dose and the Zenvia 20/10 mg dose were significantly more advanced than placebo for decreasing PBA episode prices. Overall, Zenvia 30/10 mg and 20/10 mg were effective, secure, and well-tolerated for the treatment of PBA in patients with underlying ALS. The new formulation of Zenvia appeared to demonstrate equivalent efficacy with a improved safety and tolerability profile possibly, compared with formulations of higher dosages. STAR TRIAL DESIGN The STAR trial was a confirmatory Stage III trial of Zenvia in sufferers with pseudobulbar affect . The randomized, multi-center, international STAR trial compared energetic treatment with Zenvia 30/10 mg Zenvia and BID 20/10 mg BID to placebo throughout a 12-week, double-blinded stage, followed by a 12-week, open-label extension study.