The GLOBAL LEADERS trial included 130 sites in 18 countries. Sites were distributed as follows: Australia (3 sites), Austria (5 sites), Belgium (6 sites), Bulgaria (8 sites), Canada (2 sites), Denmark (2 sites), France (13 sites), Germany (17 sites), Hungary (8 sites), Italy (6 sites), Brazil (5 sites), Netherlands (9 sites), Poland (7 sites), Portugal (4 sites), Singapore (2 sites), Spain (9 sites), Switzerland (6 sites), and the United Kingdom (18 sites).
The first patient was enrolled on July 1st 2013, at CHU de Charleroi, Charleroi, Belgium, with Dr. Adel Aminian being the site Principal Investigator. Enrolment of all participants, amounting to 15991 was achieved on November 9th 2015 at UMBAL St. George, Plovdiv, Bulgaria with Dr. Gincho Tonev being the site Principal Investigator. The achieved rate of enrolment was 4.4 patients/site/month.
Enrolment per country was distributed as follows: Australia (83 patients), Austria (672 patients), Belgium (2187 patients), Bulgaria (945 patients), Canada (170 patients), Denmark (131 patients), France (849 patients), Germany (2269 patients), Hungary (527 patients), Italy (1578 patients), Brazil (248 patients), Netherlands (1162 patients), Poland (1540 patients), Portugal (113 patients), Singapore (142 patients), Spain (951 patients), Switzerland (705 patients), and the United Kingdom (1719 patients). The top 3 enrolling sites in the GLOBAL LEADERS were:
The GLOBAL LEADERS achieved 2 Years of follow-up on 28th of February 2018, which was used for reporting the primary endpoint.