Reviewer’s comment: These protocol deviations are not expected to have an effect on the analyses or conclusions of the overall study. The eligibility criteria deviations that were of most concern were those which enrolled patients with node negative disease or tumors less than 1 cm. Of the total deviations due to eligibility criteria, there were 13 that met these criteria. More common eligibility criteria deviations were ECG criteria, which again were unlikely to affect the outcome of the overall study.