The primary end point of the trial is a composite of all-cause mortality, MI, stroke
, hospitalization for angina, and hospitalization for congestive heart failure. Enrollment was estimated at around 2000 patients, and the trial was to be completed in July 2009. So far, 1500 patients have been enrolled and 22 000 injections of EDTA been given.
There is skepticism, however, in the medical community about the safety and efficacy of chelation therapy.