OFAMI 2001.

Methods	Omacor Following Acute Myocardial Infarction (OFAMI) RCT, parallel, 2 arms (omega 3 vs corn oil), 2 years Summary risk of bias: moderate or high
Participants	Patients recruited 4‐8 days after confirmed MI N: 150 intervention, 150 control Level of risk for CVD: high Men: 77% intervention, 82% control Mean age in years (SD): 64.4 intervention, 63.6 control (no SD) Age range: 28‐86 years intervention, 29‐87 years control Smokers: 39% intervention, 38% control Hypertension: 29% intervention, 23% control Medications taken by at least 50% of those in the control group: b‐blockers, aspirin Medications taken by 20%‐49% of those in the control group: statins, ACE inhibitors Medications taken by some, but less than 20% of the control group: diuretics, warfarin Location: Norway Ethnicity: unclear
Interventions	Type: supplement (capsules) Comparison: EPA + DHA vs omega 6 Intervention: 4 gelatin capsules of omega‐3‐acid ethyl esters 90 (Omacor, Pronova A/S, Oslo, Norway), each is 1 g containing 850‐882 mg EPA and DHA as concentrated ethylesters Dose ˜3.4‐ 3.5 g/d EPA + DHA Control: corn oil capsules, 4/d, each contains 1 g of corn oil Compliance: assessed by questionnaire and capsule count, 82% intervention group had complete compliance after 6 weeks, 86% of controls Length of intervention: 24 months
Outcomes	Main study outcome: CV events Dropouts: unclear Available outcomes: total and CV deaths, MI, unstable angina, interventions, combined CV events, BMI, lipids, BP (authors provided additional data on glucose, AF, stroke) Response to contact: yes
Notes	Study funding: Pharmacia‐Upjohn and Pronova
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned" – Pharmacia was responsible for randomisation. Author response: participants were randomised in blocks of 4
Allocation concealment (selection bias)	Low risk	Author confirmed allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical capsules containing either Omacor or corn oil. Double blinding stated, but taste not reported as masked and blinding of participants not checked
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Author stated: all later analyses performed without the knowledge of outcome
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Number of dropouts was unclear
Selective reporting (reporting bias)	Unclear risk	Trials registry NCT01422317. Outcomes reported in trials registry appear to have been published, but registration was retrospective.
Attention	Low risk	All participants appear to have been reviewed at the same intervals
Compliance	Unclear risk	Assessed by questionnaire and capsule count, 82% intervention group had complete compliance after 6 weeks, 86% of controls
Other bias	Low risk	No further bias noted