| Key inclusion criteria |
| Male or female aged 40–80 years |
| Current or ex-smokers with a smoking history of ≥10 pack-years |
| An established history of COPD with an FEV1/FVC ratio <0.70 and an FEV1 ≥50 and ≤70% of predicted normal |
| A history of CVD or to be at increased risk for CVD |
| For patients ≥40 years of age this is defined as any one of the following: established coronary artery disease, established peripheral vascular disease, previous stroke, previous myocardial infarction or diabetes mellitus with target organ disease |
| For patients ≥60 years of age, any one of the above or two of the following: being treated for hypercholesterolaemia, being treated for hypertension, being treated for diabetes mellitus or being treated for peripheral vascular disease |
| Key exclusion criteria |
| Current diagnosis of asthma or respiratory disorders other than COPD |
| Chest radiograph indicating diagnosis other than COPD |
| Undergone lung volume reduction surgery and/or a lung transplant |
| Requirement for long-term oxygen therapy at start of study (>12 h per day) |
| Receiving long-term oral corticosteroid therapy |
| Current severe heart failure (NYHA class IV), subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator |
| Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study |
| End-stage chronic renal disease |
COPD: chronic obstructive pulmonary disease; SUMMIT: Study to Understand Mortality and Morbidity in COPD; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; CVD: cardiovascular disease; NYHA: New York Heart Association.