213 sites in 21 countries (Asia, Australia, Europe, North and South America)
P3 / DFS at 0.025 at 1-sided (with 1IA: p=0.0122, final: p=0.0214), if significant then OS at 0.025 at 1-sided(with 3IA, 1st: p=0.0011, 2nd=0.0055, 3rd: p=0.0138 and final: p=0.0200)