EXSCEL — design and population

§2Design and population

§2.1Design and allocation

Design class

Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial

Masking

Double-blind with independent endpoint adjudication

Arms

2

Allocation

Randomised between the intervention and its comparator

Endpoint adjudication

Independent, blinded to assignment

Data monitoring

Independent data monitoring committee with access to unblinded accumulating data

§2.2Arms

Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.

§2.3Population

Indications. Atherosclerotic cardiovascular disease and cardiovascular risk reduction · Type 2 diabetes mellitus

Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.

Geographic footprint. United States · Canada · Germany · Denmark · Sweden · Norway · Finland · Netherlands · Belgium · France · Spain · Italy · Poland · Czechia · Hungary · Japan · Taiwan · New Zealand · Mexico · Argentina.

§2.4Eligibility as the Institute reads it

• Included. Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
• Excluded. Participants for whom the intervention is contraindicated, including severe renal impairment or end-stage renal disease (egfr below 30 ml/min/1.73 m²). Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.