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POTENTIALLY ELIGIBLE

  • Diabetes Mellitus (type 1 or 2)
  • Male or Female
  • No diagnosed occlusive arterial disease
  • Aged >= 40 years

IDENTIFICATION AND INVITATION

  • Potentially eligible patients identified from existing diabetes registers and databases
  • Permission sought from GP to approach suitable individuals
  • Invitation letter sent (by GP or Diabetologist) with Information Leaflet, Consent Form and brief Screening Questionnaire (& central Freefone number for any questions)

SCREENING PROCESS (-2 MONTHS)

  • Screening Questionnaire returned, which identifies eligible and consenting patients
  • Run-in pack with 2-month supply of treatment mailed to patient
  • GP informed of patient's possible participation, and asked to return form if patient not to be randomised
  • Blood and urine samples (optional) collected locally and mailed to central laboratory
  • Freefone number for medical advice and any questions

RANDOMISATION (0 MONTHS)

  • Randomisation Questionnaire sent to re-confirm eligibility, and to characterize the patient more fully
  • Randomisation Questionnaire returned, and eligible patient randomised by central computer
  • Allocated treatment pack mailed to patient: 100 mg aspirin daily or matching placebo tablet, and 1g omega-3 FA daily or matching placebo capsule
  • GP informed of patient's randomisation

FOLLOW-UP QUESTIONNAIRES (6-monthly)

  • Follow-up Questionnaires and treatment packs sent 6-monthly
  • Freefone number for medical advice and any questions
  • Further details sought from responsible clinicians about any relevant events reported on Follow-up questionnaires
  • Flagging for mortality and cancer at central registries