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. 2018 Jan 8;2018(1):CD008074. doi: 10.1002/14651858.CD008074.pub2

2. Suggested design for a trial.

Methods Allocation: randomised, clearly described, concealed.
 Blindness: double, described and tested.
 Duration: 2 weeks.
Participants Diagnosis: thought to be psychoses.
 N = 300.*
 Age: any.
 Sex: both.
History: acutely ill, aggressive and/or agitated.
Interventions 1. Aripiprazole IM: dose flexible within recommended limits. N = 150.
 2. Haloperidol IM: dose flexible within recommended limits. N = 150.
Outcomes All outcomes are grouped by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours, and over 24 hours.
Tranquillisation or asleep ‐ tranquil; asleep.
Repeated need for tranquillisation ‐ needing additional injections.
 Specific behaviours ‐ self‐harm, including suicide, injury to others.
 Global outcomes ‐ patient satisfaction; use of restraint or seclusion.
 Service outcomes ‐ length of hospitalisation; readmission rate.
 Mental state ‐ effect of medication on mental state.
 Adverse effects ‐ medication significant side effects.
 Leaving the study early ‐ detailed reasons provided.
Quality of life outcomes.
 Economic outcomes.
Notes * Powered to be able to identify a difference of ˜20% between groups for primary outcome with adequate degree of certainty

IM: intramuscular