Recruitment and blinding
RECRUITMENT
This trial was open label with no blinding. Patients were recruited in 15 sites across two countries (the USA and Canada) among patients of the site or among patients referred from other hospitals from September 2018 to February 2022. Sites were at either academic or community hospitals. The phase 1 portion of the clinical trial was enrolled based on slot availability; the study had established sites for the study that would screen patients at those locations to determine eligibility for the trial. The phase 2 portion was an open enrollment to the active participating sites. To participate in this study and before any non-routine baseline or screening evaluation, investigators at each study site ensured that each patient was fully informed of the study and had signed a written informed consent. The patient’s eligibility was evaluated during the screening period before enrollment. No bias emerging from recruitment is expected. Patients were enrolled irrespective of gender, which was self-reported by the patient. Randomization was not performed, as we report results from the single-arm dose-expansion cohort.