Table 1

Results for the primary outcome using the BPDSI and the main safety outcome (SAEs)

	Intervention (N=103)		Control (N=101)					Effect size
Primary outcome: BPDSI
	M	SD	M	SD	Adjusted mean difference	95% CI	P value	Cohen’s d	95% CI
Baseline	34.05	7.77	33.84	7.16	n.a.			−0.03	−0.30 to 0.25
3 months	27.85	7.42	29.47	8.40	1.50	−0.42 to 3.42	0.13	0.20	−0.07 to 0.48
6 months	26.98	8.36	26.97	9.27	0.57	−1.73 to 2.88	0.62	0.00	−0.28 to 0.27
12 months	23.49	7.50	25.69	8.69	2.34	0.02 to 4.66	<0.05	0.27	0.00 to 0.55
Main safety outcome: SAE
	n	%	n	%	Wald χ²₁		P value	OR	95% CI
Baseline	29	29.0	30	29.4	n.a.			0.98	0.53 to 1.82
3 months	17	24.6	23	32.4	1.037		0.31	0.68	0.32 to 1.42
6 months	22	28.6	18	30.5	0.081		0.77	0.90	0.42 to 1.91
12 months	21	28.0	12	19.7	1.213		0.27	1.58	0.70 to 3.54

BPDSI, borderline personality disorder severity index; M, mean; n.a., not applicable; SAE, serious adverse event.