Table 1.

Demographic characteristics of subjects from the AVA000 clinical trial^a

Parameter	Value	n	Mean SI	SD	Median SI	Q1	Q3	P valueb
Overall		275	5.5	8.3	1.9	1.2	6.1
Age group (yr)	<30	63	6.6	8.2	2.9	1.3	8.5	0.025
	30–39	64	5.6	8.7	1.9	1.2	4.1
	40–49	83	6.0	8.8	2.1	1.2	7.4
	50–62	65	3.7	7.1	1.5	1.0	3.6
Sex	Female	139	5.9	8.6	2.0	1.2	6.8	0.433
	Male	136	5.1	7.9	1.9	1.2	5.5
Race	Other race/ethnicity	57	4.9	7.1	1.9	1.2	5.1	0.555
	White	218	5.7	8.5	2.0	1.2	6.2
Clinical site name	Baylor	62	4.3	5.0	2.4	1.3	5.1	<0.001
	Emory	43	11.1	12.0	6.7	2.2	15.4
	Mayo	40	8.6	11.3	2.5	1.3	11.0
	UAB	57	4.2	6.8	1.5	1.1	2.6
	WRAIR	73	2.6	3.7	1.5	1.0	2.7
Arm/group	TRT-4IM (3IM)	56	4.5	6.7	1.4	1.1	4.8	0.600
	TRT-5IM (3IM)	55	6.2	9.3	2.4	1.1	5.5
	TRT-7IM (3IM)	53	6.2	9.2	1.9	1.3	7.4
	TRT-8IM (4IM)	56	4.9	7.0	2.1	1.2	5.3
	TRT-8SQ (4SQ)	55	5.9	8.9	1.9	1.2	6.7

^aSee Marano et al. for a description of the study groups (9). Prior to sampling at week 30, the 3IM arms (TRT-4IM, TRT-5IM, and TRT-7IM) received 3 intramuscular (IM) doses of AVA (0.5 ml) at 0 and 4 weeks and 6 months with 0.5 ml placebo at 2 weeks; the 4IM arm (TRT-8IM) received 4 IM doses of AVA (0.5 ml) at 0, 2, and 4 weeks and 6 months; and the 4SQ (TRT-8SQ) arm received 4 doses SQ AVA 0.5 ml at 0, 2, and 4 weeks and 6 months. Q1 and Q3, the first and third quartiles, respectively. SQ, subcutaneously; TRT, treatment; SI, stimulation index; Baylor, Baylor College of Medicine; Emory, Emory University School of Medicine; Mayo, Mayo Clinic; UAB, University of Alabama at Birmingham; WRAIR, Walter Reed Army Institute of Research.

^bData represent the results of analysis of variance using log-transformed SI values.