Table 4. Patient demographic and baseline characteristics.

Characteristic	VSL#3	Placebo
Gender (male:female)	49:22 (69%)	44:29 (60.3%)
Age in years (mean±s.d.)	47.7±14.1	46.4±14.4
Number of previous relapses (mean±s.d.)	2.24±1.05	2.37±1.04
UCDAI at entry (mean±s.d.)	5.52±1.33	5.42±1.43
Disease extent (number of patients) (%)
Proctosigmoiditis	36 (50.7%)	38 (52.1%)
Left-sided colitis	24 (33.8%)	21 (28.8%)
Pancolitis	11 (15.5%)	14 (19.1%)
Concomitant medications
Mesalamine alone (mean/median±s.d.)	65 (91.55%) (2.08/2.4±0.39)	69 (94.52%) (2.08/2.4±0.40)
Balsalazide alone (mean/median±s.d.)	2 (2.82%) (4.5/4.5)	2 (2.74%) (4.5/4.5)
Azathioprine alone (mean/median±s.d.)	1 (1.23%) (1.62/1.5±0.25)	0 (0%)
Methotrexate alone (mean/median±s.d.)	1 (1.23%) (15 mg i.m./week)	0 (0%)
No medications	0 (0%)	0 (0%)
Combinations of drugs
Mesalamine+azathioprine (mean/median±s.d.)	2 (3.90%) (2.08/2.4±0.39)+(1.62/1.5±0.25)	2 (2.74%) (2.08/2.4±0.40)+ 1.75/1.75±0.25
Balsalazide+azathioprine	0 (0%)	0 (0%)
Balsalazide+methotrexate	0 (0%)	0 (0%)
Total	71 (100%)	73 (100%)

i.m., intra-muscular; UCDAI, ulcerative colitis disease activity index.