Table 3. Changes from baseline in safety endpoints of special interest during the AOM 400 maintenance phase.

Parameter	Enrollment source
	Enrolled from 52-week study (n=464)		Enrolled from 38-week study (n=474)		De novo (n=143)		All patients (N=1081)
Weight change at last visit	N	n (%)	N	n (%)	N	n (%)	N	n (%)
Weight gain ⩾7%	460	59 (12.8)	473	48 (10.1)	143	27 (18.9)	1076	134 (12.5)
Weight loss ⩾7%	460	25 (5.4)	473	41 (8.7)	143	16 (11.2)	1076	82 (7.6)
Weight, kg	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)
Baselinea	460	77.4 (18.9)	474	83.1 (21.4)	143	94.9 (23.6)	1077	82.2 (21.4)
Last visit Δ	460	0.8 (4.5)	473	0.3 (4.9)	143	1.0 (7.3)	1076	0.6 (5.1)
Serum prolactin, ng/mL	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)
Baselinea	442	6.2 (7.0)	451	5.5 (8.1)	118	5.0 (4.4)	1011	5.8 (7.3)
Last visit Δ	439	−0.5 (5.0)	448	−0.4 (4.0)	113	−0.5 (4.1)	1000	−0.5 (4.5)
EPS rating scale total scores, observed cases	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)	N	Mean (s.d.)
SAS
Baseline	462	10.47 (1.28)	472	10.83 (1.99)	134	11.07 (2.37)	1068	10.70 (1.79)
Last visit Δ	458	−0.05 (1.19)	471	−0.07 (1.28)	132	−0.55 (2.75)	1061	−0.12 (1.51)
AIMS
Baseline	464	0.21 (0.95)	472	0.30 (1.30)	134	0.42 (1.79)	1070	0.28 (1.24)
Last visit Δ	460	−0.05 (0.63)	471	−0.04 (0.92)	132	−0.14 (1.28)	1063	−0.05 (0.87)
BARS
Baseline	464	0.06 (0.31)	472	0.14 (0.47)	134	0.28 (0.66)	1070	0.13 (0.45)
Last visit Δ	460	−0.02 (0.33)	471	0 (0.36)	132	−0.13 (0.71)	1063	−0.02 (0.41)

Abbreviations: Δ, change; AIMS, Abnormal Involuntary Movement Scale; AOM 400, aripiprazole once-monthly 400 mg; BARS, Barnes Akathisia Rating Scale; EPS, extrapyramidal symptoms; SAS, Simpson-Angus Scale.

N=Number of patients with ⩾1 baseline or postbaseline assessment of the given parameter; n=number of patients with weight gain or weight loss ⩾7%.

^aDefined as the last evaluation before the first AOM 400 injection.