How are patients classified in an intent-to-treat population?

In an intent-to-treat population, patients are classified based on the principle of preserving the random assignment throughout the study, regardless of whether they completed the study, adhered to the protocol, or experienced adverse effects. This means that all patients who were randomized to a study therapy are included in the analysis, maintaining the integrity of the randomization process and minimizing biases that may arise if only a subset of patients were analyzed.

This approach helps to ensure that the findings of the study are as generalizable as possible and that they reflect the real-world effectiveness of the treatment, as it includes all participants, regardless of their compliance with the study protocol. By maintaining the random assignment, the results are less likely to be influenced by confounding factors.