TABLE 3.
Secondary clinical end-points
| End-point | Descriptive details |
| PEx | Proportion of subjects with protocol-defined PEx# overall and between Day 0 and Day 28 Number of PEx Proportions of subjects receiving any additional antibiotics Time to first PEx |
| Patient-reported outcomes | CFQ-R, CFRSD, CRISS |
| Other clinical end-points | Change in FEV1 from baseline to end of study Change in weight and percentile from baseline to end of study |
| Microbiology end-points | Proportion of subjects who are negative at Day 28 and remain MRSA negative and/or are MRSA negative at 3 months and 6 months Proportion of MRSA isolates developing resistance to any study medication Emergence of Pseudomonas aeruginosa infection |
| Adverse events | Frequency, by body system and severity |
| Microbiological adverse events | Emergence of small-colony variant MRSA¶ |
PEx: pulmonary exacerbation; CFQ-R: Cystic Fibrosis Questionnaire Revised quality of life respiratory domain symptom score; CFRSD: Cystic Fibrosis Respiratory Symptom Diary; CRISS: Chronic Respiratory Infection Symptom Score; FEV1: forced expiratory volume in 1 s; MRSA: methicillin-resistant Staphylococcus aureus. #: per modified Fuchs criteria [28]; ¶: differs between STAR-too and STAR-ter.