Table I.

Major symptom score (MSS) from visit 1 (day 1) to visit 5 (day 14): FAS and PP.

		FAS		PP
MSS by visit		BNO 1016 480 mg (n = 294)	Placebo (n = 295)	BNO 1016 480 mg (n = 213)	Placebo (n = 220)
Visit 1 (day 0)	Mean (SD)	10.02 (1.61)	9.87 (1.52)	9.70 (1.28)	9.65 (1.27)
Visit 2 (day 3)	Mean (SD)	7.71 (2.40)	7.86 (2.71)	7.50 (2.11)	7.78 (2.53)
Visit 3 (day 7)	Mean (SD)	5.54 (2.74)	6.15 (3.13)	5.15 (2.45)	6.14 (3.06)
Visit 4 (day 10)	Mean (SD)	4.11 (2.66)	5.05 (3.44)	3.77 (2.32)	4.93 (3.42)
Visit 5 (day 14)*†	Mean (SD)	2.47 (2.55)	3.63 (3.63)	2.06 (2.31)	3.76 (3.76)
p value*†		p < 0.0001		p < 0.0001
Difference [placebo – BNO 1016 480 mg] (SD)		1.17 (3.14)		1.70 (3.13)

*One-sided; alpha = 0.025.

†ANCOVA.

FAS, full analysis set; PP, per-protocol population; SD, standard deviation.