Figure 2.

CONSORT Diagram. Inclusion/exclusion criteria were applied in the order asked and are described in greater detail in Table 1 and Supplementary Table 1. BP/Meds refers to the allowable systolic blood pressure depending on the number of anti-hypertensive medications taken. High-risk factors included ≥75 years of age, history of clinical or subclinical cardiovascular disease other than stroke, chronic kidney disease, or having a ≥ 15% 10-year Framingham risk score for cardiovascular disease. Participants without at least one were excluded. Miscellaneous reasons for exclusion include a known secondary cause of hypertension that causes safety concern (N=17), significant proteinuria within the past 6 months (N=67), history of diabetes (N=116) or stroke (N=49), end-stage renal disease or polycystic kidney disease (N=7), glomerulonephritis treated with immunosuppressive therapy (N=1), symptomatic heart failure within last 6 months or left ventricular ejection fraction <35% (N=15), expected survival less than three years (N=5), cancer diagnosed within the last two years (N=33), living in the same household as another SPRINT participant (N=11), organ transplant (N=2), indication for a specific blood pressure medication that is not currently being taken without documented intolerance (N=16), cardiovascular event, procedure, or hospitalization for unstable angina within the last 3 months (N=6), factors likely to limit adherence (N=319), participation in another trial (N=30), unintentional weight loss > 10% in last 6 months (N=8), and pregnancy, trying to become pregnant, or of child-bearing potential and not practicing birth control (N=1).