Patients and study design
SECONDARY
The study design for the randomized, double-blind, placebo-controlled, phase III TAGS study (NCT02500043) has been reported previously [TAGS was designed and conducted in accordance with the Declaration of Helsinki and ethical principles of good clinical practice and local regulations. All protocols and amendments were approved by the institutional review boards and ethics committees prior to study initiation. All patients provided written informed consent prior to study participation.The primary endpoint of the study was OS. Key secondary endpoints were progression-free survival (PFS) and safety and tolerability.