Table 2.

Mean 24-hour average pain intensity score change from baseline to week 4 (ANCOVA), intent-to-treat population.

	Statistic	ISC 17536, treatment A	Placebo, treatment B
Absolute value and change from baseline to end of treatment (week 4)
Baseline	N	70	66
	Mean (SD)	6.0 (1.04)	6.1 (1.07)
	Min†, max	2.4, 8.3	3.7, 8.9
Change from baseline (Week 4)	N	70	66
	Mean (SD)	−1.9 (1.66)	−1.7 (1.58)
	Min, max	−6.1, 0.9	−7.0, 1.7

Visit	No. of patients		LS means		Treatment A-B
	A	B	A	B	LSM difference	95% CI
Statistical assessment of change from baseline in the API score*
Week 4	70	66	−1.94	−1.68	−0.26	(−0.81, 0.28)

The baseline mean 24-hour API score was the mean of 24-hour API scores during the 7 days before randomization. The week 4 mean 24-hour API score was the mean of the 24-hour API scores obtained between day 23 and day 29 during the fourth week of treatment.

^*The change from baseline to week 4 in the mean 24-hour API score was analyzed with an ANCOVA model with terms for treatment and baseline 24-hour API score as covariates.

^†The minimum baseline mean 24-hour API scores are < 4 (lower than the limit set by an inclusion criterion) because this table shows that in the ITT population (rather than the PP [per-protocol] population), 1 patient in the ISC 17536 group and 1 patient in the placebo group had baseline scores of 2.4 and 3.67, respectively.

ANCOVA, analysis of covariance; API, average pain intensity; BID, twice daily; CI, confidence interval; ITT, intent-to-treat; LS mean or LSM, least-square mean; Max, maximum; Min, minimum; N, number of patient.