4 results
The study aims to determine the safety and efficacy of the steering module in a clinical setting.
To evaluate two different placebo intrauterine systems, pentagon-shaped placebo FR01 and traingle-shaped FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
Primary Objective: To evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs…
Primary: To collect long-term safety data.Secondary objectives: To collect long-term efficacy data (LDL-C).