Based on REDEFINE trial populations and the NDA submission terms, expected eligibility criteria are: BMI 30 , or BMI 27 with at least one weight-related condition such as hypertension, dyslipidemia, type 2 diabetes, or obstructive sleep apnea Adults 18 years or older Not pregnant or breastfeeding Contraindications will likely include: personal or family history of MTC or MEN 2 syndrome, prior serious allergic reaction to semaglutide or cagrilintide, and active pancreatitis
In some embodiments, the otoprotectant is a compound of Formula (VIII) having the structure of Formula (VIIIa): In some embodiments, the otoprotectant is a compound of Formula (IX): wherein: R 1 is C 6 -C 10 aryl or C 3 -C 9 heteroaryl, wherein C 6 -C 10 aryl and C 3 -C 9 heteroaryl are optionally substituted with one or more R 4
How are Klow and Glow tested
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Vigorously scrub the rubber stoppers on top of both vials with an alcohol prep pad and allow them to air dry for about 30-60 seconds
