And this part from Bob..

As I mentioned, the main safety objective of the study was to establish a bridge between Gen2 and the MedTone pulmonary safety data by demonstrating that the main change in FEV1, the forced expiratory volume in one second, from baseline to week 24 was comparable between the Gen2 and the MedTone treatment groups. We achieved this objective observing that these two values differed at week 24 by an insignificant 0.01 liters and that's from a baseline value in excess of 3.4 liters.