Study design
ASTRIS is an open-label, single-arm, multinational, real-world study. The study was approved by the Institutional Review Board/Ethics Committee and conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, local regulatory requirements, and the policy on bioethics and human biologic samples of AstraZeneca. The study protocol was designed by the sponsor (AstraZeneca, Södertälje, Sweden) in collaboration with investigators and is registered at clinicaltrials.gov (NCT02474355). All patients provided their written informed consent.