Table 4.

Day 15 mean change from baseline in clinical signs and symptoms score (intent-to-treat population)

Visit 4 (day 15)	Combination (n=305)	0.1% dexamethasone (n=298)	1% azithromycin (n=155)	Vehicle (n=149)	All subjects (N=907)
n*	303	294	155	148	900
Mean change from baseline (standard deviation)	−3.5 (2.09)	−3.4 (2)	−2.8 (2.15)	−2.9 (2.08)	−3.2 (2.08)
Within-group P-value§	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001
Overall and pairwise P-values§
vs dexamethasone	0.7196
vs 1% azithromycin	0.0029	0.0077
vs vehicle	0.0131	0.0294	0.6929
Overall					0.0036

Notes:

^*There were seven subjects who were enrolled and received the study drug, but did not have any measurements after baseline; these seven subjects were thus not included in the analyses of changes in clinical signs and symptoms. The last observation carried forward was used for imputation of any missing data.

^§Within-group P-values from one-sample t-tests on mean change; overall and pairwise P-values derived from analysis of variance with main effect of treatment groups. Combination =0.1% dexamethasone and 1% azithromycin.