. Author manuscript; available in PMC: 2015 Jul 1.

Published in final edited form as: Lancet Respir Med. 2014 May 15;2(7):539–547. doi: 10.1016/S2213-2600(14)70100-6

Table 2. Summary of % predicted FEV₁ at Baseline and Week 48 (ITT Population).

Visit/Parameter	Treatment Arm (All)		Treatment Arm (No chronic inhaled tobramycin)
	Ataluren	Placebo	Ataluren	Placebo
Baseline, N	116	116	72	74
Mean (SD)	62.09 (13.62)	60.23 (15.14)	61.6 (13.11)	60.5 (15.68)
Week 48, N	100	103	62	63
Mean (SD)	60.37 (16.68)	57.18 (16.70)	61.2 (15.77)	56.976 (16.84)
Δ from baseline to Week 48
Mean (SD)	-1.34 (8.50)	-3.10 (7.39)	-0.3 (7.53)	-3.7 (7.58)
P-value¹	0.1170		0.0122
Relative Δ from baseline to Week 48
Mean (SD) MMRM P-value²	-2.53 (13.25)	-5.50 (12.56)	-0.7 (11.93)	-6.4 (12.64)
Mean (SD) MMRM P-value²	0.1235		0.0082³

Abbreviations: FEV1 = forced expiratory volume in 1 second, MMRM = mixed model repeated measures, SD = standard deviation

P-value based on t-test comparison of ataluren and placebo.

P-value based on MMRM analysis for comparison of ataluren and placebo.

P-value not adjusted for multiplicity.

Table 2. Summary of % predicted FEV1 at Baseline and Week 48 (ITT Population).