Table 2.

Baseline Demographics—Ascending Single Doses (Safety Population)

Category	Statistics	RT234 0.2 mg (N = 6)	RT234 0.6 mg (N = 6)		RT234 1.2 mg (N = 6)	RT234 1.2 mg (N = 6)	Repeated-dose RT234 2.4 mg (N = 8)
			RT234/oral vardenafil (N = 3)	Oral vardenafil/RT234 (N = 3)
Age (years)	n	6	3	3	6	6	8
	Mean	23.7	23.0	27.3	24.8	26.8	27.1
	SD	3.78	4.36	4.93	7.36	6.27	2.42
	Median	23.5	25.0	25.0	23.0	27.5	27.5
	Min	19	18	24	18	18	24
	Max	30	26	33	38	36	31
Gender, n (%)	Male	1 (16.7)	1 (33.3)	1 (33.3)	1 (16.7)	4 (66.7)	7 (87.5)
	Female	5 (83.3)	2 (66.7)	2 (66.7)	5 (83.3)	2 (33.3)	1 (12.5)
Race, n (%)	Asian	1 (16.7)	1 (33.3)	0	2 (33.3)	2 (33.3)	1 (12.5)
	White	5 (83.3)	2 (66.7)	3 (100)	4 (66.7)	3 (50.0)	7 (87.5)
	Multiple	0	0	0	0	1 (16.7)	0
Ethnicity, n (%)	Hispanic or Latino	1 (16.7)	0	1 (33.3)	0	3 (50.0)	0
	Not Hispanic or Latino	5 (83.3)	3 (100)	2 (66.7)	6 (100%)	3 (50.0)	8 (100)
Body weight (kg)	n	6	3	3	6	6	8
	Mean	65.75	68.7	75.10	66.78	69.92	74.9
	SD	7.872	11.640	12.474	9.411	8.724	12.319
	Median	68.00	74.50	79.60	65.45	70.65	74.35
Body weight (kg)	Min	51.7	55.3	61.0	55.1	59.5	57.3
	Max	73.3	76.3	84.7	83.0	78.5	96.0
BMI (kg/m2)	n	6	3	3	6	6	8
	Mean	22.43	23.57	23.83	23.55	23.87	24.46
	SD	2.545	2.597	1.656	2.824	2.726	3.176
	Median	22.35	23.00	24.0	23.60	24.90	25.45
	Min	19.7	21.3	22.1	20.5	20.3	20.2
	Max	26.4	26.4	25.4	28.1	26.6	28.6

Age (years) = integer value ([Date Signed Informed Consent − Date of Birth +1]/365.25).

BMI, body mass index; Max, maximum; Min, minimum; SD, standard deviation.