Trial abstract · §2
EPI-RU-ELDERLY — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Observational cohort analysis
- Masking
- Not applicable
- 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.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Epithalon | — | — | Intervention at the dose reached after titration |
| Placebo | — | — | Matched placebo, administered on the same schedule |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Biological ageing and healthspan endpoints
Interventions proposed to modify rate of biological ageing, assessed by composite biomarker clocks, functional measures, or mortality.
Geographic footprint. South Africa.
§2.4Eligibility as the Institute reads it
- Included. Interventions proposed to modify rate of biological ageing, assessed by composite biomarker clocks, functional measures, or mortality.
- 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.
Compound Evidence Institute · CEI-TR-0110/2 · https://compoundevidence.com/trials/epi-ru-elderly/design/ · retrieved 30 July 2026