Woman and Man
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Extract
The primary objective is to demonstrate the efficacy of a 28-day, twice-daily (BID) dosing regimen of TIP versus placebo, as measured by the relative change in forced expiratory volume at 1 second (FEV1) % predicted from baseline (week 1/cycle 1, day 1) to the end of cycle 1 dosing (week 5/cycle 1, day 28).
Inclusion criteria
- pulmonary P aeruginosa infection in patient with cystic fibrosis