Inclusion criteria
Determine eligible and ineligible participants
Exclusion criteria are NOT the negative of inclusion criteria!!!
They apply to eligible participants that become ineligible due to situations that :
Would preclude informed consent
Make participation in the research unsafe for researchers and/or participants
May complicate interpretation of research outcome data, (e.g. Participants take part to similar/other studies)
Interfere with achieving the study objectives
May require monitoring or care beyond research scope (for clinical studies)