Table 3 Adverse events and changes in Extrapyramidal Symptom Rating Scale (ESRS) scores and metabolic parameters

	Treatment group
	0 weeks		24 weeks		52 weeks
	N	%	N	%	N	%
Serious adverse events
Death	0	0	0	0	1	2
Non-serious adverse events
Cold/cold Symptoms	5	10	6	11	7	13
Headache	9	17	3	6	6	11
Weight gain	4	8	6	11	7	13
Fatigue/sedation/sleep change	4	8	5	9	4	8
Muscle related injuries	4	8	3	6	5	9
Constipation	3	6	5	9	1	2
Menstrual irregularity/cramps	2	4	2	4	6	11
Nausea	3	6	4	7	1	2
Diarrhea	1	2	4	7	2	4
Breast changes/galactorrhea	1	2	3	6	1	2
Dry mouth	2	4	1	2	1	2
Dry skin/itch/rash	1	2	2	4	1	2
Extrapyramidal symptoms	1	2	2	4	1	2
Bloating/flatulence	1	2	1	2	1	2
Dizziness	0	0	2	4	1	2
Hair loss	1	2	0	0	2	4
Impaired sexual function	0	0	3	6	0	0
Elevated glucose	0	0	1	2	1	2
Elevated prolactin level	0	0	1	2	1	2
Impaired vision	0	0	2	4	0	0
Increased appetite	0	0	1	2	1	2
Elevated lipids	0	0	1	2	0	0
Elevated liver function test	0	0	1	2	0	0
Increased dreaming	0	0	1	2	0	0
Tardive dyskinesia	1	2	0	0	0	0
Other	6	12	3	6	3	6
Change from baseline to last visit	Mean	s.d.	Mean	s.d.	Mean	s.d.
ESRS score
Total	1.3	8.9	2.3	8.3	2.3	9.8
Parkinsonism+Dystonia subscale	−0.7	3.2	−0.2	1.8	0.0	4.2
Dyskinesia subscale	0.02	0.32	0.00	0.00	0.02	0.14
Metabolic parameters
Weight (kg)^a	−0.2	4.8	−0.1	6.8	3.2	6.8
Glucose level (mmol I⁻¹)	0.7	3.7	−0.01	0.7	0.1	0.9
Cholesterol level (mmol I⁻¹)	−0.2	1	−0.3	0.7	0.02	1.0
Triglycerides (mmol I⁻¹)	0.3	1.6	−0.02	0.7	0.1	1.8

Abbreviation: s.d., standard deviation.
^aP-value=0.01 for the difference between the 52-weeks and 0-weeks groups and between the 52-weeks and 24-weeks groups.

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