TB4-PH1-CARDIAC — design and population

§2Design and population

§2.1Design and allocation

Design class

Phase 1 single- and multiple-ascending-dose study

Masking

Double-blind within dose cohort, sponsor-open

Arms

2

Allocation

Randomised between the intervention and its comparator

Endpoint adjudication

Not applicable to the primary endpoint of this design

Data monitoring

As specified in the protocol

§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

Indication. Atherosclerotic cardiovascular disease and cardiovascular risk reduction

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. Norway · Taiwan.

§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 not established — no marketing authorisation. 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.