 The initial goal at INT was to recruit 10,000 subjects from 10 different Italian centres by the end of 2008. This task has proven unfeasible for a number of reasons, including the lack of available institutions with sufficient experience and logistic facilities to run large long-term trials, and the strong campaign in the media in favor of early detection programmes, which has made the randomisation in a control arm unacceptable for a large proportion of volunteers. As a matter of fact, despite the formal collaboration of Istituto Superiore di Sanità ISS Rome, signed in February 2006, and the acceptance of the protocol by the Ethics Committee of many Italian centres, only two other Institutions have started active accrual by July 2007. 