Table 3 Definition of population analysis sets
Analysis population | Early pharmacological treatment group | Expectant management group |
|---|---|---|
Intention-to-treat ‘as randomised’ | Early pharmacological treatment randomisation: Including all protocol deviations. | Expectant management randomisation: Including all protocol deviations. |
Per-protocol | Early pharmacological treatment randomisation and treated according to study protocol: Excluding other protocol deviations. | Expectant management randomisation and treated according to study protocol: Including those patients who received ‘open label’ pharmacological treatment and fulfilled the ‘open label’ criteria as described in the protcol; Excluding those patients who received ‘open label’ treatment not according to ‘open label’ criteria in study protocol; Excluding other protocol deviations. |