. 2021 Sep 15;22:627. doi: 10.1186/s13063-021-05594-x

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.

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.