Fig. 1

CONSORT Flow Diagram. AE adverse event, ERS efficacy response analysis set, FAS full analysis set, PD progressive disease, SS safety set, PKCS pharmacokinetic concentration set, PKPS Pharmacokinetic parameter set
CONSORT Flow Diagram. AE adverse event, ERS efficacy response analysis set, FAS full analysis set, PD progressive disease, SS safety set, PKCS pharmacokinetic concentration set, PKPS Pharmacokinetic parameter set