HEX-PH2-ELDERLY — design and population

§2Design and population

§2.1Design and allocation

Design class

Randomised, double-blind, placebo-controlled, parallel-group

Masking

Double-blind (participant, investigator and sponsor)

Arms

5

Allocation

Randomised across dose arms and a common 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. Sarcopenia and lean-mass preservation during weight reduction

Loss of skeletal muscle mass and function, considered here principally as a consequence of rapid weight reduction under incretin therapy.

Geographic footprint. Czechia.

§2.4Eligibility as the Institute reads it

• Included. Loss of skeletal muscle mass and function, considered here principally as a consequence of rapid weight reduction under incretin therapy.
• 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.