MacFadden 2010.

Methods	Allocation: random. Blinding: open‐label, rater blind. Duration: 2 years. Design: parallel. Setting: international, multi‐centre (USA, South America, India).
Participants	Diagnosis: schizophrenia (DSM‐IV). N = 355. Age: ≥18 years of age. Sex: 210 M, 139 F. History: not described. Included: DSM‐IV schizophrenia not controlled by current medication (judged by clinician); 2+ relapses (defined as "psychiatric hospitalisation caused by worsening of psychiatric symptoms; a change in antipsychotic treatment or significant increase in antipsychotic dose because of inadequate efficacy; a newly emergent, clinically important symptom such as 'suicidality'; or a clinically notable increase in the frequency or intensity of subject contact") in the past 2 years. Stable for 2 months before randomisation. Excluded: PANSS ≥100, current hospitalisation, major medication changes, or worsening of psychiatric symptoms within two months before study entry. Current treatment with clozapine, carbamazepine or depot antipsychotics. Evidence of alcohol or drug dependence (DSM‐IV Axis I criteria) within six months before entry. Consent: study conducted in accordance with Declaration of Helsinki and Good Clinical Practice; approved by Institutional Review Board or independent ethics committee at each centre. Written informed consent required.
Interventions	1. Risperidone depot: 25‐50 mg/2 weeks, n = 177. 2. Oral aripiprazole: 5‐30 mg/daily, n = 172.*
Outcomes	Global state: mean time to relapse/time in remission. Mental state: PANSS. Specific adverse events; weight; movement disorders; death; serious adverse events. Laboratory tests.
Notes	*Other medications permitted, including antidepressants, anxiolytics, mood stabilisers. At clinician's judgement, if psychotics symptoms worsened, another antipsychotic was added (excluding clozapine) for up to seven days; this treatment continued if considered appropriate by investigators. If this proved ineffective, the investigator had the option to use another different secondary antipsychotic.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised: "subjects were randomly assigned in a 1:1 ratio" but no details on how this was achieved.
Allocation concealment (selection bias)	Unclear risk	Concealment not described.
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label, participants and study drug administrators were not blinded, but with blinded raters.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"The proportions of injectable RLAT and aripiprazole subjects who discontinued the study before completing two years were 29.6% and 28.4%, respectively" and reasons for discontinuation are given. Of the original n = 355 randomised, n = 346 were included in ITT analysis.
Selective reporting (reporting bias)	Unclear risk	None detected.
Other bias	High risk	Study authors employed by Janssen: "Dr. Macfadden was with Ortho‐McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey, at the time of this analysis; Drs. Ma and Haskins are with Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey; and Drs. Bossie and Alphs are with Ortho‐McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey."