Methods	RCT
Participants	Men with previous MI (Australia) CVD risk: high Control: randomised 237, analysed 221 at 2 years Intervention: randomised 221, analysed 205 at 2 years Mean years in trial: control 4.3, intervention 4.3 % male: 100 Age: mean control 49.1 (sd 6.5), intervention 48.7 (sd 6.8)
Interventions	Modified fat diet vs usual diet Control aims: reduction in energy if overweight, no other specific dietary advice, allowed to use PUFA margarine instead of butter Intervention aims: SFA 10%E, PUFA 15%E, reduction in energy if overweight, dietary chol <300mg/day Control methods: no specific dietary instruction (except re weight) Intervention methods: advised and tutored individually, diet assessed 3 times in first year and twice annually thereafter Total fat intake (“during follow up”): mod fat 38.3 (sd 5.9), cont 38.1 (sd 5.4)%E Saturated fat intake (“during follow up”): mod fat 9.8 (sd 2.6), cont 13.5 (sd 3.2)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: cardiovascular mortality and morbidity Data available on total mortality? yes Cardiovascular mortality? no (overall number given, but not by intervention group) Events available for combined cardiovascular events: none Secondary outcomes: none Tertiary outcomes: total cholesterol, TG
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“random numbers”
Allocation concealment (selection bias)	Unclear risk	Randomisation method not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Physician blinding: adequate participant blinding: inadequate
Incomplete outcome data (attrition bias) All outcomes	Low risk	Survival analysis used
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias	Low risk
Free of systematic difference in care?	High risk	Advice and follow up in intervention group, not in control. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat?	Low risk	See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies