HPS * Front Cover * Contents * Section 1 * Section 2 * Section 3 * Appendix * References * Back Cover


CONTENTS

SUMMARY OF THE STUDY AIMS AND DESIGN

1. BACKGROUND AND RATIONALE

1.1 CHOLESTEROL AND CORONARY HEART DISEASE: EXISTING EVIDENCE

1.2 HMG CoA REDUCTASE INHIBITORS: THE SUBSTANTIAL, SUSTAINED CHOLESTEROL REDUCTIONS PRODUCED BY THESE AGENTS PROVIDE AN OPPORTUNITY TO ADDRESS THE TOTAL MORTALITY QUESTION

1.3 CHOLESTEROL AND TOTAL MORTALITY: NEED FOR A LARGE TRIAL

1.4 RELIABLE ASSESSMENT OF THE EFFECTS OF ANTIOXIDANT VITAMIN SUPPLEMENTATION

2. PLAN OF INVESTIGATION

2.1 AIMS

2.2 INCLUSION OF A WIDE RANGE OF PEOPLE AT HIGH RISK OF CHD

2.3 TREATMENT COMPARISONS

2.4 SAMPLE SIZE AND PREDICTED NUMBERS OF EVENTS

2.5 ASSESSMENT OF OUTCOME AND DATA MONITORING

2.6 CENTRAL COORDINATION AND COLLABORATING CLINICS

3. SUMMARY OF PRACTICAL PROCEDURES (see Hospital Manual for details)

FLOW CHART

3.1 ELIGIBILITY AND IDENTIFICATION OF SUITABLE PATIENTS

3.2 SCREENING CLINIC VISIT (-2 MONTHS)

3.3 RANDOMISATION CLINIC VISIT (0 MONTHS)

3.4 POST-RANDOMISATION CLINIC FOLLOW-UP

3.5 CENTRAL ASCERTAINMENT OF BIOCHEMICAL EFFECTS, AND OF VASCULAR EVENTS, CANCERS AND CAUSE-SPECIFIC MORTALITY

APPENDIX: Suggested information leaflet for potentially eligible patients (to be revised as considered necessary by local ethics committees)

REFERENCES

STEERING AND DATA MONITORING COMMITTEES, AND CONTACT DETAILS FOR COORDINATING CENTRE

HPS * Front Cover * Contents * Section 1 * Section 2 * Section 3 * Appendix * References * Back Cover