2.3. Removal, dropout, and discontinuation criteria

Poor compliance and inability to complete the entire trial in strict compliance with the clinical protocol and on time.

Unwillingness to continue the clinical trial and requests to the supervising physician to withdraw.

Failure to start the study drug for various reasons after signing the informed consent form.

Statistical analysis of the data prior to the discussion with the statistician and principal investigator to determine exclusion.

Discontinuation of chemotherapy in the event of disease progression, death or unacceptable adverse reactions (AEs), followed by discontinuation of the trial drug and withdrawal from the trial.