Table 1.

Operational characteristics of the clinical program by region

	Eastern Europe/Turkey	Western Europe/Israel	USA/Canada	South America/Mexico	Asia	Australia/South Africa
Sites that screened at least 1 patient	83	135	132	45	27	16
Randomized 0 patients	1	6	19	1	5	2
Randomized 1 patient only	2	14	23	2	4	2
Randomized 0–1 patients (%)	3 (3.6)	20 (14.8)	42 (31.8)	3 (6.7)	9 (33.3)	4 (25.0)
Patients screened per montha	1.23	1.78	1.41	2.03	2.07	1.98
Patients randomized per monthb	0.84	1.22	0.58	1.30	0.92	0.98
Randomization ratec	0.69	0.64	0.48	0.66	0.51	0.54
Completion rated	0.89	0.90	0.89	0.88	0.90	0.86
Protocol deviation ratee	1.79	2.33	1.35	2.64	1.47	1.44

^aMean of values for each site (number of patients screened/duration of screening period in months). Screening period was defined as the time from first patient screened to last patient screened at the site; sites that screened patients for a period of < 7 days were assigned a screening period of 7 days for this calculation

^bMean of values for each site (number of patients randomized/duration of screening period in months). Screening period was defined as the time from first patient screened to last patient screened at the site; sites that screened patients for a period of < 7 days were assigned a screening period of 7 days for this calculation

^cMean of values for each site (number of patients randomized/number of patients screened)

^dTotal number of patients completed across all sites/total number of patients randomized across all sites

^eMean of values for each site (number of protocol deviations throughout the study/number of patients screened)