The inclusion and exclusion criteria are in place so all subjects are:

Inclusion and exclusion criteria are designed to ensure that participants are medically appropriate for the study and are not ethically vulnerable. This reduces risks to subjects and ensures that the collected data accurately reflects the target population.

The answer follows GCP principles that emphasize participant safety and data validity through well-defined inclusion/exclusion criteria.

"Inclusion and exclusion criteria are crucial for ensuring the safety of participants and the scientific validity of study results."

Objectives:

Ensuring participant safety.

Maintaining ethical standards in clinical research.