Using an Intention-to-Treat analysis in a randomized clinical trial means:

1. participants should not be enrolled unless they really intend to comply with the intervention being tested. This is usually assessed during a "run-in" period when their compliance with the study protocol is tested before the trial begins

2. All participants have to agree to be randomized and adhere to all study protocols in the trial. 3. Any participant randomized into one of the trial arms should be included in the final analysis, but only if they complied with the intervention during the entire course of the trial 4. participants randomized into a trial arm must be included in the final analysis based on the arm they were originally randomized to, regardless of whether or not they adhered to the study protoco