3 results
Primary: To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs. Key secondary: Ability to completely…
1. To explore the pharmacokinetics (PK) of intra-vaginal delivery of gonadorelin and oxybutynin. 2. To assess the safety and tolerability of gonadorelin and oxybutynin delivery with a prototype intra-vaginal ring.
The primary efficacy objective of this study is to:* Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the…