Dietary fat intake and prevention of cardiovascular disease: systematic review
BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7289.757 (Published 31 March 2001) Cite this as: BMJ 2001;322:757Data supplement
- Table posted as supplied by author
Table A Characteristics of included trials
Included trial arm Validity Participants§ Intervention Dietary fat intake achieved* BDIT Pilot Studies16 Randomisation method: "randomly allocated" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: unclear
Women with mamographic dysplasia (Canada) CVD risk: low
Control n: 147
Intervention n: 148
Mean follow-up: 7.2 years
% male: 0
mean age: 45 (all >30)
Control aims: healthy diet advice, no alteration in dietary fat advised Intervention aims: dietary advice aims: total fat 15%E, replace fat by complex carbohydrates
Mode of intervention: diet advice
Control group: Total fat: 35.3, Sats: 12.3, Monos: 16.4, Polys: 6.6
Intervention group:
Total fat: 31.7, Sats: 10.6, Monos: 15.3, Polys: 5.8
DART17 Randomisation method: "randomised" Physician blinding: unclear
Participant blinding: unclear
Systematic difference in care?: no
Men recovering from MI (UK) CVD risk: high
Control n: 1015
Intervention n: 1018
Mean follow-up: 1.89 years
% male: 100
mean age: 57 (all <70)
Control aims: no dietary advice on fat Intervention aims: dietary advice aims: reduce fat intake to 30%E, increase P/S ratio to 1.0
Mode of intervention: diet advice
Control group: Total fat: 35, Sats: 15,
Monos: 13, Polys: 7
Intervention group:
Total fat: 31, Sats: 11,
Monos: 11, Polys: 9
Diet & Gallstones18 Randomisation method: "randomly allocated" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
People with radiolucent gallstones taking UDCA (USA) CVD risk: low
Control n: 17
Intervention n: 19
Mean follow-up: 0.59 years
% male: 47
mean age: 53
Control aims: dietary advice aims: total fat 38-42%E, dietary cholesterol 500mg/day Intervention aims: dietary advice aims: limit dietary cholesterol to 250mg/day
Mode of intervention: diet advice
Control group: Total fat: 36.0
Intervention group:
Total fat: 32.5
German Fat Reduced19 Randomisation method: "participants assigned to a random number, later numbers sorted and assigned" Physician blinding: unclear
Participant blinding: unclear
Systematic difference in care?: no
women with body mass index from 24 to 29 (Germany) CVD risk: low
Control n: 35
Intervention n: 35
Mean follow-up: 0.73 years
% male: 0
mean age: 47 (all 40 to 60)
Control aims: dietary advice aims: to buy foods from trial shop, usual fat foods supplied Intervention aims: dietary advice aims: to buy foods from trial shop, low fat foods supplied
Mode of intervention: dietary advice and supplement (food (supplied through trial shop))
Control group: Total fat: 35.5
Intervention group:
Total fat: 35.1
Glasgow Diet in HT20 Randomisation method: "stratified by hypertensive treatment and randomly allocated" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: minor
People with hypertension and cholesterol >6.5 mmol/L (UK) CVD risk: moderate
Control n: 72
Intervention n: 72
Mean follow-up: 0.46 years
% male: 49
mean age: 56
Control aims: no dietary advice Intervention aims: dietary advice aims: reduce serum cholesterol
Mode of intervention: diet advice
Control group: No data provided
Intervention group:
No data provided
Glasgow Weight Loss21 Randomisation method: "medical officer drew coloured straws from a box" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
Healthy women with body mass index > 25 (UK) CVD risk: low
Control n: 53
Intervention n: 57
Mean follow-up: 0.43 years
% male: 0
mean age: 51
Control aims: dietary advice aims: total fat 35%E, carbohydrate 34.5%E, 1200 kcal per day Intervention aims: dietary advice aims: total fat 20%E, carbohydrate 58%E, 1200 kcal/day
Mode of intervention: diet advice
Control group: No data provided
Intervention group:
No data provided
Kentucky Low Fat22 Randomisation method: "matched on age, gender & cholesterol level, randomly assigned to intervention group using systematic random procedure" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: minor
Moderately hypercholesterolaemic non-obese, caucasian men & women (USA) CVD risk: moderate
Control n: 62
Intervention n: 115
Mean follow-up: 0.91 years
% male: 60
mean age: 41 (all 30 to 50)
Control aims: no diet intervention Intervention aims: dietary advice (seminars and one-to-one), aims: 25%E from fats, 20%E from protein, 55%E from carbohydrate, <200 mg cholesterol/day (with differing amounts of fibre)
Mode of intervention: diet advice
Control group: Total fat: 31, Sats: 10, Monos: 11, Polys: 7
Intervention group:
Total fat: 28, Sats: 8, Monos: 10, Polys: 7
Kuopio Fat Modified23 Randomisation method: "randomisation stratified for men & women, singles & couples, random number tables" Physician blinding: inadequate
Participant blinding: inadequate
Systematic difference in care?: no
Free-living people with serum total cholesterol levels 6.5 to 8.0 mmol/L (Finland) CVD risk: moderate
Control n: 37
Intervention n: 41/ 40/ 41
Mean follow-up: 0.5 years
% male: 46
mean age: 46 (all 30 to 60)
Control aims: dietary advice aims: total fat 38%E, saturates <18%E, monounsaturates 15%E, polyunsaturates <5%E, rapeseed oil, butter and semi-skimmed milk provided Intervention aims: AHA – total fat 30%E, saturates <10%E, monounsaturates 10%E, polyunsaturates 10%E, sunflower oil, sunflower spread and skimmed milk provided
Low fat – total fat 28-30%E, saturates <14%E, monounsaturates 10%E, polyunsaturates 4%E, butter and rapeseed spread and skimmed milk provided
Mono - total fat 38%E, saturates <14%E, monounsaturates 18%E, polyunsaturates <6%E, rapeseed oil, rapeseed spread and skimmed milk provided
Mode of intervention: dietary advice and supplement (food)
Control group: Total fat: 36, Sats: 15, Monos: 10, Polys: 4
Intervention group:
AHA – Total fat: 34,
Sats: 11, Monos: 8,
Polys: 8
Low fat – Total fat: 31, Sats: 12, Monos: 8,
Polys: 3
Mono - Total fat: 35,
Sats: 11, Monos: 12,
Polys: 6
Linoleic Enrichment24 Randomisation method: "stratified according to gender, randomised in blocks of 6 using opaque sealed envelopes" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
People with type 1 diabetes and elevated urinary albumin (Netherlands) CVD risk: moderate
Control n: 20
Intervention n: 18
Mean follow-up: 1.95 years
% male: 78
mean age: 43 (all 21 to 65)
Control aims: usual diet (asked not to alter fat or protein intake) Intervention aims: dietary advice aims: replace sats by linoleic acid to achieve P/S of 1.0, total fat and protein intake to remain unchanged
Mode of intervention: diet advice
Control group: Total fat: 40, Sats: 16,
Monos: 15, Polys: 9 Intervention group:
Total fat: 37, Sats: 13,
Monos: 12, Polys: 12
London Corn / Olive25 Randomisation method: "sealed envelopes" Physician blinding: inadequate Participant blinding: inadequate
Systematic difference in care?: no
People with angina or following MI (UK) CVD risk: high
Control n: 26
Intervention n: 28/ 26
Mean follow-up: 1.53 years
% male: 100?
mean age: 55 (all <70)
Control aims: usual diet Intervention aims:
Corn – dietary advice aims: restrict dietary fat, plus 80g/day corn oil provided
Olive - dietary advice aims: restrict dietary fat, plus 80g/day olive oil provided
Mode of intervention: diet advice plus supplement (oil)
Control group: Total fat: 32.6
Intervention group:
Corn – Total fat: 50.5
Olive - Total fat: 46.2
London Low Fat26 Randomisation method: "allocated at random to one of two groups at each hospital" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
Men recently recovered from their first MI (UK) CVD risk: high
Control n: 129
Intervention n: 123
Mean follow-up: 3.0 years
% male: 100
mean age: 45 (all <65)
Control aims: continuation of usual diet, overweight subjects given weight reduction advice (mainly carbohydrate reduction) Intervention aims: dietary advice to reduce fat intake to 40g daily, overweight subjects given weight reducing advice
Mode of intervention: diet advice
Control group: Total fat: 43.3
Intervention group:
Total fat: 19.9
Low Fat in Breast Cancer27 Randomisation method: "stratification by age, randomisation with block size of 2" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: minor
women at high risk of breast cancer (USA) CVD risk: low
Control n: 96
Intervention n: 98
Mean follow-up: 1.7 years
% male: 0
mean age: 46 (all 18 to 67)
Control aims: asked to maintain usual diet Intervention aims: dietary advice aims: total fat 15%E
Mode of intervention: diet advice
Control group: Total fat: 33.8, Sats: 11.3, Monos: 12.0, Polys: 6.9 Intervention group:
Total fat: 18.0, Sats: 6.0, Monos: 6.1, Polys: 3.8
Mastopathy Diet28 Randomisation method: "randomly allocated" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: minor
women with severe cyclical mastopathy for at least 5 years (Canada) CVD risk: low
Control n: 10
Intervention n: 11
Mean follow-up: 0.45 years
% male: 0
mean age: 38
Control aims: given principles of healthy diet, not counseled to alter fat content of diet Intervention aims: dietary advice aims: total fat 15%E, carbohydrate 65%E
Mode of intervention: diet advice
Control group: Total fat: 33.4, Sats: 12.3, Monos: 13.7, Polys: 7.4 Intervention group:
Total fat: 22.8, Sats: 8.8, Monos: 10, Polys: 4.0
Minnesota Coronary29 Randomisation method: "stratified randomisation" Physician blinding: adequate
Participant blinding: adequate
Systematic difference in care?: no
Institutionalised men and women living in a mental hospital (USA) CVD risk: low
Control n: 4516
Intervention n: 4516
Mean follow-up: 1.0 years
% male: 49
mean age: ? (range from <30 to >60)
Control aims: diet provided aims: usual institutional diet Intervention aims: diet provided aims: total fat 45%E, PUFA 18-20%E, P/S 2.5, less than 150 mg/day dietary cholesterol
Mode of intervention: diet provided
Control group: Total fat: 39.1, Sats: 18.3, Monos: 15.6, Polys: 5.2 Intervention group:
Total fat: 37.8, Sats : 9.2, Monos: 13.9, Polys: 14.7
MRC Soya30 Randomisation method: "allocated at random" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: no
Free living men who survived a first MI (UK) CVD risk: high
Control n: 194
Intervention n: 199
Mean follow-up: 3.7 years
% male: 100
mean age: ? (all <60)
Control aims: usual diet Intervention aims: dietary advice to reduce dietary fat to 35g fat per day, with the addition of 84g soya oil per day
Mode of intervention: diet advice plus supplement (soya oil)
Control group: Total fat: 43
Intervention group:
Total fat: 46
MSFAT31 Randomisation method: "stratified randomisation (according to sex, age, QI index and eating behaviour) by co-coordinating centre" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
Healthy people (Netherlands) CVD risk: low
Control n: 120
Intervention n: 120
Mean follow-up: 0.48 years
% male: 50
mean age: 36 (all 20 to 55)
Control aims: advised to use products from trial shop ad libitum (usual fat products provided) Intervention aims: advised to use products from trial shop ad libitum (low fat products provided)
Mode of intervention: dietary advice plus supplements (food provided by trial shop)
Control group: Total fat: 42.7, Sats: 18.2, Monos: 14.7, Polys: 6.8 Intervention group:
Total fat: 34.7, Sats: 14.2, Monos: 12.4, Polys: 6.2
National Diet-Heart32 Randomisation method: "central stratified randomisation" Physician blinding: adequate
Participant blinding: adequate
Systematic difference in care?: no
Men living in an institution (USA) CVD risk: low
Control n: 781
Intervention n: 1475
Mean follow-up: 0.58 to 0.96 years in different trial arms
% male: 100
mean age: ? (all 45 to 54)
Faribault 1st Control aims: diet provided aims: sats 16-18%E, dietary cholesterol 650-750 mg/d, total fat 40%E, P/S ratio 0.4
Intervention aims:
B - diet provided aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 15%E, total fat 30%E, P/S ratio 1.5
C - diet provided aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 18-20%E, total fat 40%E, P/S ratio 2.0
E - diet provided aims: total fat 40%E, P/S ratio 4.4
Mode of intervention: diet provided
Open 1st
Control aims: dietary advice to reduce sats and cholesterol, plus purchase of fat modified foods from a special trial shop, aims: sats 16-18%E, dietary cholesterol 650-750 mg/d, total fat 40%E, P/S ratio 0.4
Intervention aims:
B – dietary advice to reduce sats and cholesterol, plus purchase of fat modified foods from a special trial shop, aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 15%E, total fat 30%E, P/S ratio 1.5
C – dietary advice to reduce sats and cholesterol, plus purchase of fat modified foods from a special trial shop, aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 18-20%E, total fat 40%E, P/S ratio 2.0
X – dietary advice to reduce sats and cholesterol, aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 15%E, total fat 30%E, P/S ratio 1.5
Mode of intervention: diet advice plus food supplement
Open 2nd
Control aims: dietary advice to reduce sats and cholesterol, plus purchase of fat modified meats from a special trial shop, aims: sats 16-18%E, dietary cholesterol 650-750 mg/d, total fat 40%E, P/S ratio 0.4
Intervention aims:
BC – sats reduced, dietary cholesterol 350-450 mg/d, increased PUFA, total fat 30-40%E, P/S ratio 1.5-2.0
F – dietary cholesterol 350-450 mg/d, increased PUFA, total fat 40%E, P/S ratio 3.0
G – dietary cholesterol 350-450 mg/d, total fat 40%E, P/S ratio 10
X – dietary advice to reduce sats and cholesterol, aims: sats <9%E, dietary cholesterol 350-450 mg/d, PUFA 15%E, total fat 30%E, P/S ratio 1.5
Mode of intervention: diet advice plus food supplement
Faribault 1st Control group:
Total fat: 39.4, Sats: 15.6, Monos: 19.2, Polys: 4.6 Intervention group:
B – Total fat: 29.2,
Sats: 6.6, Monos: 10.8, Polys: 11.8
C – Total fat: 38.5,
Sats: 7.4, Monos: 13.8, Polys: 17.3
E - Total fat: 37.1,
Sats: 4.9, Monos: 10.3, Polys: 21.9
Open 1st
Control group:
Total fat: 34.9, Sats: 11.6, Monos: 18.4, Polys: 4.9 Intervention group:
B – Total fat: 29.7,
Sats: 7.1, Monos: 12.7, Polys: 9.9
C – Total fat: 34.4,
Sats: 7.4, Monos: 13.8, Polys: 13.2
X – Total fat: 31.7,
Sats: 8.9, Monos: 16.3, Polys: 6.5
Open 2nd
Control group:
Total fat: 35.5, Sats: 12.0, Monos: 18.1, Polys: 5.4 Intervention group:
BC – Total fat: 32.5,
Sats: 7.4, Monos: 13.4, Polys: 11.7
F – Total fat: 35.1,
Sats: 7.8, Monos: 13.9, Polys: 13.4
G – Total fat: 35.8,
Sats: 10.5, Monos: 17.6, Polys: 7.7
X – Total fat: 32.0,
Sats: 8.0, Monos: 15.6, Polys: 8.4
Oslo Diet-Heart33 Randomisation method: "table of random numbers used" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: no
Men with previous MI (Norway) CVD risk: high
Control n: 206
Intervention n: 206
Mean follow-up: 4.3 years
% male: 100
mean age: 56 (all 30 to 67)
Control aims: dietary advice not provided, but direct questions answered, supplement: 1 vitamin tablet daily Intervention aims: dietary advice aims: reduce meat and dairy fats, increase fish, vegetables, supplement: 1 vitamin tablet daily, 0.5L soy bean oil per week (free to 25% of participants), sardines in cod liver oil (free at certain times)
Mode of intervention: diet advice plus supplement (food)
Control group: No data provided
Intervention group:
No data provided
Oxford Retinopathy34 Randomisation method: "random number sequence provided and allotted by a separate agency" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
People with newly diagnosed type 2 diabetes (UK) CVD risk: moderate
Control n: 125?
Intervention n: 125?
Mean follow-up: 9.3 years
% male: 49
mean age: 47 (all <65)
Control aims: dietary advice aims: total fat 40%E, polyunsaturates 12%E, protein 20%E, carbohydrates 40%E (reducing simple sugars), 1500 kcal/day Intervention aims: dietary advice aims: total fat 26%E, polyunsaturates 16%E, protein 20%E, carbohydrates 54%E (reducing simple sugars), 1500 kcal/day
Mode of intervention: diet advice
Control group: No data provided
Intervention group:
No data provided
Sollentuna Diet35 Randomisation method: "blinded drawing of lots by the study physician" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: minor
Men with moderately raised risk factors for cardiovascular disease (Sweden) CVD risk: moderate
Control n: 40
Intervention n: 40
Mean follow-up: 0.5 years
% male: 100
mean age: 46 (all 35 to 60)
Control aims: usual diet Intervention aims: dietary advice aims: total fat 30%E, sats <10%E, monounsaturates 10-15%E, polyunsaturates up to 10%E, dietary cholesterol <300
mg/day
Mode of intervention: diet advice
Control group: Total fat: 36, Sats: 15.7, Monos: 12.4, Polys: 5.4 Intervention group:
Total fat: 34, Sats: 14.2, Monos: 11.7, Polys: 5.3
Stanford Weight36 Randomisation method: "assigned at random" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: minor
Sedentary, moderately overweight, non-smoking normotensive men (USA) CVD risk: low
Control n: 44
Intervention n: 45
Mean follow-up: 0.9 years
% male: 100
mean age: ? (all 25 to 49)
Control aims: no dietary advice Intervention aims: dietary advice aims: total fat <30%E, sats 10%E, total carbohydrate >55%E, <300
mg cholesterol/day, with weight reduction
Mode of intervention: diet advice
Control group: Total fat: 38.5
Intervention group:
Total fat: 31.7
STARS37 Randomisation method: "blinded random cards issued centrally by statistician advisor" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: no
Men with angina referred for angiography (UK) CVD risk: high
Control n: 30
Intervention n: 30
Mean follow-up: 3.0 years
% male: 100
mean age: 51 (all <66)
Control aims: no diet intervention Intervention aims: dietary advice aims: total fat 27%E, sats 8-10%E, omega-3 and omega-6 polyunsaturates 8%E, increase in plant-derived soluble fibre, dietary cholesterol 100 mg/ 1000 kcal
Mode of intervention: diet advice
Control group: Total fat: 37, Sats: 17, Monos: 17, Polys: 5
Intervention group:
Total fat: 27, Sats: 9, Monos: 9, Polys: 7
Sydney Diet-Heart38 Randomisation method: "random numbers" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: no
Men with previous MI (Australia) CVD risk: high
Control n: 237
Intervention n: 221
Mean follow-up: 4.3 years
% male: 100
mean age: 49 (all 30 to 59)
Control aims: reduction in energy if overweight, no other specific dietary advice, allowed to use polyunsaturated margarine instead of butter if wished Intervention aims: dietary advice aims: sats 10%E, polyunsaturates 15%E, reduction in energy if overweight, dietary cholesterol <300 mg/day
Mode of intervention: diet advice
Control group: Total fat: 38.1, Sats: 13.5, Monos: 13.8, Polys: 8.9
Intervention group:
Total fat: 38.3, Sats: 9.8, Monos: 11.5, Polys: 15.1
Toronto Polyp Prevention39 Randomisation method: "stratification by physician, gender, age, randomisation by research associate, centrally, using random numbers generated by computer" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: minor
People after adenomatous colorectal polypectomy (Canada) CVD risk: low
Control n: 102
Intervention n: 99
Mean follow-up: 2.0 years
% male: 55
mean age: 58 (all <85)
Control aims: dietary advice aims: nutritionally balanced diet (optional low fibre supplement with added calcium and iron) Intervention aims: dietary advice aims: total fat <20%E, at least 50g fibre daily (optional fibre supplement with added calcium and iron)
Mode of intervention: dietary advice plus supplement (food)
Control group: Total fat: 31.5
Intervention group:
Total fat: 24.3
Turku Weight40 Randomisation method: "randomised according to gender, age and overweight" Physician blinding: unclear
Participant blinding: inadequate
Systematic difference in care?: yes
Adults 30-50% overweight (Finland) CVD risk: low
Control n: 44
Intervention n: 46/ 46
Mean follow-up: 0.9 years
% male: 26
mean age: ? (all 25 to 50)
Control aims: usual diet Intervention aims:
Mixed – dietary advice aims: total fat 25-30%E, 1200 kcal/day, low in sugar, high in fibre and vegetables, moderate meat, fish and eggs
Vegetarian – dietary advice aims: total fat 20-25%E, 1200 kcal/day, low in sugar, high in fibre and vegetables, no meat, fish or eggs
Mode of intervention: diet advice
Control group: Total fat: 37
Intervention group:
Mixed – Total fat: 32
Vegetarian – Total fat: 25
Veterans Admin. 41 Randomisation method: "table of random numbers used" Physician blinding: adequate
Participant blinding: adequate
Systematic difference in care?: no
Men living at the Veterans Administration Center (USA) CVD risk: low
Control n: 422
Intervention n: 424
Mean follow-up: 3.66 years
% male: 100
mean age: 65 (all 54 to 88)
Control aims: diet provided aims: total fat 40%E Intervention aims: diet provided aims: total fat 40%E, 2/3 of sats replaced by unsats, dietary cholesterol reduced
Mode of intervention: diet provided
Control group: Total fat: 40.0, Sats: 18.5, Monos: 17.1, Polys: 4.4 Intervention group:
Total fat: 38.9, Sats: 8.3, Monos: 14.6, Polys: 16.1
Veterans Skin Cancer42 Randomisation method: "list of randomly generated numbers" Physician blinding: adequate
Participant blinding: inadequate
Systematic difference in care?: minor
People with non-melanoma skin cancer (USA) CVD risk: low
Control n: 67
Intervention n: 66
Mean follow-up: 1.9 years
% male: 60
mean age: 52
Control aims: no dietary advice Intervention aims: dietary advice aims: total fat 20%E, protein 15%E, carbohydrate 65%E
Mode of intervention: diet advice
Control group: Total fat: 37.8, Sats: 12.8,
Monos: 14.4, Polys: 7.8 Intervention group:
Total fat: 20.7, Sats: 6.6,
Monos: 7.6, Polys: 4.5
*Total fat, saturated fat (Sats), monounsaturated fat (Monos) and polyunsaturated fat (Polys) are all expressed as a percentage of total energy intake.
§CVD risk, or baseline risk of cardiovascular disease was defined as follows: high risk - participants with existing vascular disease (including myocardial infarction, stroke, peripheral vascular disease, angina, heart failure, previous coronary artery bypass grafting or angioplasty); moderate risk - familial risk, dyslipidaemia, diabetes mellitus, hypertension, chronic renal failure; low risk – others or mixed population groups. Mean follow-up time was calculated by dividing the total person years in trial (calculated, where not stated, from number randomised, follow up time and drop outs or deaths) by the number randomised.
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