TABLE 1

Demographics and Baseline Characteristics (Safety Population)

CharacteristicDose-ranging study (n = 12)Phase III study (n = 63)
Age (y)
 Mean62.0 (12.7)54.4 (15.7)
 Median59.5 (44.0, 83.0)54.0 (25.0, 82.0)
Height (cm)
 Mean172.1 (9.9)171.9 (11.43)
 Median171.4 (157.4, 193.0)172.7 (147.3, 199.9)
Weight (kg)
 Mean72.4 (19.8)84.3 (21.2)
 Median69.8 (45.3, 113.4)80.7 (51.7, 148.3)
Sex
 Male5 (41.7)28 (44.4)
 Female7 (58.3)35 (55.6)
Race
 American Indian or Alaska Native0 (0)0 (0)
 Asian0 (0)2 (3.2)
 Black or African American0 (0)6 (9.5)
 Native Hawaiian or other Pacific Islander0 (0)0 (0)
 White12 (100.0)54 (85.7)
 Other0 (0)1 (1.6)
Ethnicity
 Hispanic or Latino0 (0)11 (17.5)
 Not Hispanic or Latino12 (100.0)52 (82.5)
 Unknown0 (0)0 (0)
 Not reported0 (0)0 (0)
  • Qualitative data are numbers followed by percentages in parentheses; continuous data are mean followed by SD and median followed by range in parentheses.