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Table 1 Baseline data collected before randomisation in the three trials

From: The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis

Data item

Fluoxetine

Placebo

Age (years (mean, SD))

  

Gender (male %)

  

Ethnicity

  

Marital status

  

Living arrangements

  

Employment

  

Independent in everyday activities before the stroke

  

Patient consented for themselves

  

Co-morbidities (existing)

 Previous ischaemic stroke/TIA

  

 Previous intracranial bleeding

  

 Known coronary heart disease

  

 Current depression

  

 Past depression

  

 Known diabetes mellitus

  

 Previous upper gastrointestinal bleeding

  

 Current or past hyponatraemia (Na < 130 mmol/L)

  

 Previous bone fractures

  

Status at enrolment

 NIHSS (median, IQR)

  

 Motor deficit present on NIHSS

  

 Aphasia present on NIHSS

  

 Ability to lift both arms

  

 Ability to walk alone

  

 Able to talk and not confused (GCS speech normal)

  

 Patient health questionnaire (PHQ)

  

 Haemorrhage on brain imaging?

  

 OCSP classification for ischaemic stroke

  

 Modified TOAST classification