TABLE 5

Exploratory subgroup analyses of relative change in forced expiratory volume in 1 s (FEV₁) from baseline to 28 days of treatment

	Subjects n	Estimate	FEV₁^# %	se	p-value
Modified ITT	54	−0.0153	−1.5	0.0201	0.4492
Modified ITT with OligoG compliance ≥100%	29	−0.0728	−7.3	0.0243	0.0059
Modified ITT with OligoG compliance <100%	25	0.0552	5.5	0.0295	0.0738
Modified ITT age ≤25 years	13	0.0437	4.4	0.0448	0.3505
Modified ITT age >25 years	41	−0.0449	−4.5	0.0235	0.0630
Modified ITT on tobramycin	16	0.0972	9.7	0.0235	0.0010
Modified ITT not on tobramycin	38	−0.0560	−5.6	0.0233	0.0217
Modified ITT on aztreonam	14	−0.0332	−3.3	0.0390	0.4123
Modified ITT not on aztreonam	40	−0.0135	−1.4	0.0233	0.5670
Modified ITT on antibiotics and with OligoG compliance <100%	24	0.0623	6.2	0.0297	0.0476
Modified ITT on continuous inhaled antibiotics	40	0.0067	0.7	0.0218	0.7625
Modified ITT on continuous inhaled antibiotics and with OligoG compliance <100%	19	0.0867	8.7	0.0335	0.0190
Modified ITT on tobramycin and with OligoG compliance <100%	10	0.1092	10.9	0.0341	0.0125
Modified ITT with BMI <20 kg·m⁻² at screening	15	0.0604	6.0	0.0429	0.1826
Modified ITT with BMI ≥20 kg·m⁻² at screening	39	−0.0439	−4.4	0.0223	0.0560
Modified ITT with FEV₁ <55% predicted at screening	20	−0.0226	−2.3	0.0275	0.4226
Modified ITT with FEV₁ 55–70% predicted at screening	18	−0.0006	−0.1	0.0314	0.9850
Modified ITT with FEV₁> 70% of predicted at screening	16	−0.0082	−0.8	0.0465	0.8630

Estimates of treatment differences from mixed models. ITT: intention-to-treat population; BMI: body mass index. ^#: percentage change in FEV₁ compared to placebo. Tobramycin treatment was always synchronised in the off-cycle.