Table 2.

Clinical outcome measures during randomised treatment phase presented as average [mean (SE)] changes from baseline during weeks 0 – 24 as measured by AUCMB

	Placebo (n = 8)	Active (n = 8)	p
Osame's score	+0.19 (0.19)	+0.18 (0.34)	0.99
Pain score	+0.43 (1.13)	+0.41 (0.66)	0.99
Bladder function
Daytime frequencya	-0.11 (0.38)	-0.19 (0.62)	0.93
Nocturiab	-0.18 (0.55)	-0.81 (0.47)	0.41

^a One patient in each group is excluded from the analysis because they had an indwelling urinary catheter

^b One patient in each group is excluded from the analysis because they had an indwelling urinary catheter. The four Japanese patients had no night urinary frequency data (2 in each group) and baseline frequency was unknown for another patient in the placebo group. All are excluded from the analysis.