Table 3.

Summary of study drug exposure.

Duration of exposure,a n [%]	Randomised, double-blind studies				Open-label studies
	Budesonide MMX 9mg/d [n = 288]	Budesonide MMX 6mg/d [n = 254]	Budesonide MMX 3mg/d [n = 17]	Placebo [n = 293]	Budesonide MMX 9mg/db [n = 89]
Mean [SD]	48.6 [15.9]	47.0 [18.0]	53.1 [9.5]	48.0 [28.3]	45.3 [15.7]
Median [range]	56.0 [1–106]	56.0 [3–89]	56.0 [28–59]	56.0 [3–421]	55.0 [8–62]
Missing	16	9	0	16	4

SD, standard deviation; d, day.

^aDuration of exposure calculated by: [day study drug returned] – [day study drug dispensed].

^bPatients receiving budesonide MMX 9mg in the open-label study had previously completed 8 weeks of treatment with budesonide MMX 9mg, budesonide 6mg, 5-ASA 2.4g/day, or placebo, in the CORE I study. Thus, patients who received budesonide MMX 9mg in the CORE I study had 16 weeks of consecutive exposure to budesonide MMX.