Table 1.

Demographics of enrolled participants.

		PD&P	FD	HFCWO
All randomized patients	N	58	51	57
	Female gender	29 (50%)	21 (41%)	25 (44%)
	Age at screening, years (SEM)	14.9 (1.1)	14.0 (1.0)	14.9 (0.93)
	Baseline FEV1 % Predicted	80.1 (2.7) *	83.8 (2.9)	83.2 (2.4)
	Genotype	n = 37	n = 34	n = 38
	ΔF508/ΔF508	22 (59%)	17 (50%)	17 (45%)
	ΔF508/other	10 (27%)	14 (41%)	15 (39%)
	Other/other	5 (14%)	3 (9%)	6 (16%)
Withdrew within first 60 days after randomization (not included in ITT analysis)	N	11	4	0
	Female gender	8 (73%)	1 (25%)	N/A
	Age at screening, years (SEM)	17.3 (1.3)	19.3 (4.8)	N/A
	Baseline FEV1 % Predicted	72.1 (6.6) *	52 (5.7)	N/A
	Genotype	n=9	n =2	N/A
	ΔF508/ΔF508	6 (67%)	0 (0%)	N/A
	ΔF508/other	1 (11%)	2 (100%)	N/A
	other/other	2 (22%)	0 (0%)	N/A
Withdrew after first 60 days	N	24	12	5
	Female gender	11 (46%)	4 (33%)	1 (20%)
	Age at screening, years (SEM)	15.1 (1.9)	15.3 (2.7)	14.6 (1.9)
	Baseline FEV1 % Predicted	80.0 (4.1)	86.0 (7.1)	64.4 (6.5)
	Genotype	n=11	n =8	n =3
	ΔF508/ΔF508	6 (55%)	4 (50%)	2 (67%)
	ΔF508/other	5 (45%)	4 (50%)	1 (33%)
	other/other	0 (0%)	0 (0%)	0 (0%)

^*- 1 patient withdrew prior to visit one.