TABLE 2.

Clinical improvement in subjective symptoms in the FAS^a

Parameterb	Value for groupc
	DWJ1248 (n = 161)	Placebo (n = 162)
Clinical improvement statusd
No. (%) of subjects with clinical improvement (event)	107 (66.46)	115 (70.99)
95% CI	59.17–73.75	64.00–77.98
Time (days) to clinical improvement in subjective symptoms by day 14d
Mean (SD)	5.94 (2.93)	6.73 (3.32)
Median	5.00	6.00
Min, max	2.00, 13.00	2.00, 15.00
Median (95% CI)g	7.00 (6.00–8.00)	8.00 (7.00–9.00)
P valuee	0.4951
Hazard ratio	1.09
95% CI	0.84–1.43
P valuef	0.5035

^aFAS, full analysis set. See the description of the FAS in Results.

^bMin, minimum; max, maximum; CI, confidence interval.

^cThe denominator of the percentage is the number of subjects who have symptoms at baseline for each group.

^dDuration (days) = (date of event/censored, whichever occurs first − date of first IP administration +1); status = event (clinical improvement) if there is clinical improvement at least once by day 14, and status = censored (no clinical improvement) if there is no improvement by day 14 but clinical improvement after day 14 or no improvement by the end of the study or there is rescue therapy usage before clinical improvement by day 14.

^eTesting for difference between DWJ1248 and placebo using the log rank test.

^fTesting for difference between DWJ1248 and placebo using the Cox proportional hazards model with treatment group as a factor and age and risk factor as covariates. If the result or CI was estimated to be infinity, hazard ratio was estimated using Firth’s penalized maximum likelihood and its CI was presented as the profile penalized likelihood confidence interval.

^gThe median time to clinical improvement and its 95% confidence interval by treatment group using the Kaplan-Meier curve.