3 results
Primary Objective: 1. To investigate the safety of cold plasma plaster treatment of diabetic foot ulcers. Secondary Objective(s): 1. To investigate the effect of cold plasma plaster treatment of diabetic foot ulcers on bacterial load.2. To…
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 objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…