Table 2:

Site-Level Efficacy Primary Analysis, T-Test Results

	COMB-R (N=6)	ESC (N=7)	Difference
Outcome	Mean (95% CI)	Mean (95% CI)	Mean difference (95% CI)	T-statistic	P-value
Mean QIDS-SR	6.70 (3.71, 9.70)	10.57 (8.80, 12.34)	−3.86 (−6.79, −0.94)	−2.91	0.01 *
% with QIDS-SR Response	62.3 (39.0, 85.5)	17.9 (7.0, 28.9)	44.3 (23.1, 65.5)	4.61	<0.001 *
% with QIDS-SR Remission	47.9 (22.7, 73.0)	17.0 (7.2, 26.8)	30.9 (8.9, 52.9)	3.09	0.01 *
Mean log10 RNA copies/ml	2.23 (1.48, 2.97)	2.06 (1.47, 2.65)	0.17 (−0.65, 0.99)	0.45	0.66
% with viral suppression (< 40 copies/ml)	57.2 (31.2, 83.3)	61.7 (27.9, 95.4)	−4.4 (−43.3, 34.4)	−0.25	0.81
Mean CD4 count (copies/uL)	703 (466, 940)	683 (524, 842)	19 (−223, 262)	0.18	0.86
% with CD4 ≥ 200 copies/uL	88.0 (64.5, 100.0)	92.1 (84.2, 100.0)	−4.1 (−27.6, 19.3)	−0.43 +	0.68
% with CD4 < 200 copies/uL	12.0 (0.0, 35.5)	7.9 (0.0, 15.8)	4.1 (−19.3, 27.6)	0.43 +	0.68

Note:

^*indicates p-value < 0.05

Note:

⁺T-test uses unequal variance based on F-test results. Blank signifies equal variances

Note: For dichotomous variables, mean value is the mean of the site-specific percentages of participants with the given response

Note: Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR) is scored from 0-27 with a higher score indicating greater symptom severity: 0-5 Not depressed, 6-10 Mild, 11-15 Moderate. 16-20 Severe, 21+ Very Severe. A participant had a QIDS-SR response if their score decreased by more than 50% from baseline. Remission was defined as a score <=5