Table 3.

Weighted Sum of the Change from Baseline in NCSi Scores from Hours 1 to 8 on Day 1 (Primary End Point, Efficacy Analysis Set, N = 563)

	Pseudoephedrine (N = 284)		Placebo (N = 279)
Day 1	Actual Result	Weighted Sum of Change From Baseline	Actual Result	Weighted Sum of Change From Baseline
Baseline
Mean (SD)	3.3 (0.47)		3.3 (0.47)
Median	3.0		3.0
Min, max	3, 4		3, 4
Sum of hours 1‐8
Mean (SD)		11.9 (6.41)		10.7 (6.98)
Median		12.0		11.0
Min, max		–4, 30		–7, 30
LS mean (SE)		12.6 (0.40)		11.4 (0.40)
Study drug difference
LS mean difference (SE)		1.2 (0.54)
95%CI		(0.12‐2.24)
P value		.029

CI, confidence interval; LS, least squares; max, maximum; min, minimum; NCSi, Nasal Congestion Severity (instantaneous); SD, standard deviation; SE, standard error.

The NCSi score was based on a scale ranging from 0 (not stuffy at all) to 4 (very stuffy). The weights used were equal to the elapsed time in hours since the previous time point. Baseline was defined as the last available assessment prior to the first dose of study drug. The difference between treatment groups was compared with an analysis of variance for each time interval with baseline congestion severity, age category, and treatment as factors.