Baldassarre 2006.

Methods	RCT, (n‐3 EPA + DHA vs MUFA), 24 months Summary risk of bias: moderate or high
Participants	45‐70 year olds with combined hyperlipoproteinaemia N: 32 intervention, 32 control Level of risk for CVD: moderate Men: 29% intervention, 29% control Mean age in years (SD): 53.7 (7.2) intervention, 53.7 (6.9) control Age range: 45‐70 years (inclusion) Smokers: 28.1% intervention, 28.1% control Hypertension: none (exclusion criteria) Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: not reported (patients on HRT, anti‐hypertensive drugs, lipid lowering drugs, or who smoked > 10 cigarettes were excluded) Location: Italy Ethnicty: not reported
Interventions	Type: capsules Comparsion: LCn3 vs MUFA Intervention: 1 g × 6 soft gelatin capsules/d of fatty acid mixture (19% EPA), 13% DHA, 19% palmitic acid, 18% oleic acid, 2% LA and 29% other minor components) providing 1.08 g/d EPA, 0.72 g/d DHA, 0.01 g/d tocopherol acetate, divided to three doses. Dose: 1.8 g/d EPA + DHA Control: 1 g × 6 opaque identical soft gelatin capsules/d of olive oil divided in 3 doses. Compliance: assessed by counting returned capsules at each visit and by measuring EPA and DHA levels at month 24 Length of intervention: 24 months
Outcomes	Main study outcome: carotid atherosclerosis measures Dropouts: 2 intervention, 5 control Available outcomes: deaths (nil), MI (lipids, weight, BP and heart rate reported but not in a usable format; lipid data were presented at various times without clear numerical data, suggesting falls in TGs in the intervention but not control arms, and rises in LDL and HDL cholesterol in intervention but not control arms. For the other outcomes the text states "a rise in body weight (+ 3%, P < 0.01) was observed at the end of the study in both groups. Blood pressure and heart rate were unchanged". Effects on IMT and platelets also reported but not used) Response to contact: not yet attempted
Notes	Study funding: supported by Institut De Recherche Pierre Fabre, Departement Recherche Clinique
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An appropriate software was used to obtain 2 groups balanced for sex, age and smoking
Allocation concealment (selection bias)	Unclear risk	No further details
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind and placebo capsules were opaque and identical looking to intervention. However no information provided on capsules taste or smell
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details
Incomplete outcome data (attrition bias) All outcomes	Low risk	All dropouts are accounted for. "One patient left the study after 3 months because he moved to another city and was therefore excluded from statistical analyses. Two patients were excluded because of major deviation from the protocol during the follow‐up (anti‐hypertensive assumption) and four because of non‐compliance on the basis of returning capsules (compliance < 70%). The final analysed group included 57 patients (30 on active treatment)."
Selective reporting (reporting bias)	Unclear risk	No protocol or trial register record
Attention	Low risk	Both groups had the same contact and number of visits.
Compliance	Low risk	Pill count, we know they excluded 4/64 who returned > 70% of capsules. So 60/64 had > 70% compliance with significant increase in serum EPA and DHA in the intervention group.
Other bias	Low risk	None noted