4 results
Primary objectivesEfficacyThe primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite…
To evaluate the safety and effecacy of the Lung Volume Reduction Coil to improve QOL pulmonary function for emphysema subjects with severe hyperinflation.
To evaluate the safety and effecacy of the Lung Volume Reduction Coil to improve QOL pulmonary function for emphysema subjects with severe hyperinflation.
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…