4 results
compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
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).