Japic CTI 142578 2015.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Study duration: 10 weeks Rescue medication: no information
Participants	Number randomised: 150 Type of dementia: Alzheimer's disease Indication: agitation Setting: hospital or care facilities Country: Japan
Interventions	Intervention characteristics Aripiprazole dosage: 2 mg/day, 3mg/day, or 6 mg/day Placebo
Outcomes	No outcomes reported
Identification
Notes	Sponsorship source: Otsuka Pharmaceutical Co., Ltd.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information
Allocation concealment (selection bias)	Unclear risk	No information
Comparability of groups (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" Use of placebo, but identical tablets not described.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information
Selective reporting (reporting bias)	High risk	The trial was early terminated after enrolment of 150 of 880 participants. The results have not been published. The company did not provide the data when one of the authors (HJL) requested them.
Other bias	Unclear risk	No information