Table 2.

Summary of the efficacy endpoints.

	Placebo [N = 54]	Budesonide foam QD [N = 55]	Budesonide foam BID [N = 56]
Endoscopic subscore ≤ 1, n [%]	25 [46.3]	38 [69.1]	43 [76.8]
Odds ratio		2.762	4.333
P-value		0.0139	0.0007
MMDAI ≤ 1, n [%]	6 [11.1]	21 [38.2]	28 [50.0]
Odds ratio		4.966	8.613
P-value		0.0022	<0.0001
Rectal bleeding subscore = 0, n [%]
Week 2	13 [24.1]	24 [43.6]	25 [44.6]
Odds ratio		2.497	2.655
P-value		0.0307	0.0208
Week 4	15 [28.3]	27 [50.0]	35 [66.0]
Odds ratio		2.552	5.617
P-value		0.0276	0.0001
Week 6	19 [37.3]	38 [70.4]	37 [69.8]
Odds ratio		4.240	4.393
P-value		0.0010	0.0008

Statistical analyses were performed at the level of significance of 0.05 [two-sided].

MMDAI, Modified Mayo Disease Activity Index; BID, twice a day administration; QD, once daily administration.