 As a consequence, the INT has decided to increase its target for the MILD trial to 4000 subjects, with the aim of joining the other two Italian randomized studies DANTE and ITALUNG to provide a strong Italian meta-analysis of at least 10,000 subjects, that might in the future be compared with the two large on-going randomised trials, the NCI trial in the United States and the Nelson trial in northern Europe Netherlands, Belgium, Denmark, providing concurrent data on the southern European population. 