3 results
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
The primary objective of the study is to generate safety and performance data for the CardiAQ* Transcatheter Mitral Valve Implant System with the Transapical Delivery System to support a future marketing application for the treatment of moderate to…
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…