Table 3.

AUC data - ITT set for (A) sore throat relief (TOTPAR) from baseline to 2 hours post dose, (B) change from baseline in difficulty swallowing from baseline to 2 hours post dose and (C) throat numbness measurements from 1 to 120 minutes post dose

	AMC/DCBA Warm lozenge	AMC/DCBA Cool lozenge	Unflavoured, non-medicated lozenge
(A) Sore throat relief (TOTPAR)
N	77	74	74
Mean ± SD	1.70 ± 1.19	2.06 ± 1.30	0.94 ± 1.04
LS meana	1.74	2.10	0.98
Parameter estimates	LS meanb	95% CI	P-value
AMC/DCBA Warm lozenge - unflavoured, non­medicated lozenge	0.76	0.38,1.14	0.0001 ***
AMC/DCBA Cool lozenge - unflavoured, non­medicated lozenge	1.12	0.73,1.50	<0.0001 ***
(B) Difficulty in swallowing
N	77	74	74
Mean ± SD	-13.4 ± 14.4	-19.2 ± 14.6	-7.7 ± 13.2
LS meanc	-13.5	-19.3	-7.5
Parameter estimates	LS meand	95% CI	P-value
AMC/DCBA Warm lozenge - unflavoured, non-medicated lozenge	-5.9	-10.4,-1.5	0.009 ***
AMC/DCBA Cool lozenge - unflavoured, non-medicated lozenge	-11.7	-16.2,-7.2	<0.0001 ***
(C) Throat numbness
N	77	74	74
Mean ± SD	1.86 ± 0.83	2.18 ± 0.86	1.54 ± 0.72
LS meana	1.80	2.12	1.48
Parameter estimates	LS meanb	95% CI	P-value
AMC/DCBA Warm lozenge - unflavoured, non-medicated lozenge	0.32	0.06,0.58	0.017 *
AMC/DCBA Cool lozenge - unflavoured, non-medicated lozenge	0.64	0.38,0.90	<0.0001 ***

a Estimated from ANCOVA model with factors for treatment and centre and a covariate for baseline throat soreness.

b A positive difference favours the first treatment against second treatment.

c Estimated from ANCOVA model with factors for treatment and centre and covariates for baseline throat soreness and baseline score for difficulty in swallowing.

d A negative difference favours the first treatment against second treatment.

*** Significantly different compared with the unflavoured, non-medicated lozenge at the 0.1% level.

CI, confidence interval; LS, least-squares; SD, standard deviation.

Sore throat relief measured on a 7-point scale where 0 = No relief, 1 = Slight relief, 2 = Mild relief, 3 = Moderate relief, 4 = Considerable relief, 5 = Almost complete relief, 6 = Complete relief.

Difficulty in swallowing measured on 100 mm VAS where 0 mm = Not difficult, 100 mm = Very difficult.

Throat numbness measured on a 5-point scale where 1 = None, 2 = Mild, 3 = Moderate, 4 = Considerable, 5 = Complete.