106 sites activated 12 country-level regulatory submissions made 11 approvals received PA 130 submitted to IRB/ EC 420 contacted for feasibility 112 SIVs conducted 119 essential document (RCR) packages reviewed and approved 76 actively recruiting 154 site contracts finalised 249 ePIPs responded 1 EDC database built 24089 pages entered 11452 queries closed 2 DSMB meetings held 189 patients randomised 649 screened 894 findings 182 monitoring events performed 16 study plans