Exploratory. Exploratory endpoints include: ▪ Change in MCC from Visit 1 (randomization) to Visit 3 (week 6) ▪ Proportions of subjects remaining on and off hypertonic saline and dornase alfa for up to 24 weeks after completion of each study ▪ Proportions of subjects with acute antibiotic use up to 24 weeks after completion of each study ▪ Average impact score at Visit 3 (Week 6) on subject perception of how stopping hypertonic saline or dornase alfa (or both) would impact their daily life 6 SUBJECT SELECTION
Appears in 3 contracts
Sources: Protocol Agreement, Protocol Agreement, Protocol Agreement