The open label extension, is merely a statement by the FDA to continue the Phase III s/c trial, but since it has been filled with 390 (394 actually), no more placebo needed, so give all new volunteers leronlimab. No efficacy data needed to justify the open label extension, and safety is certainly known not to be of any concern.

All patients receiving leronlimab under the open label extension, must be at a leronlimab Phase III s/c trial site, and must volunteer to be added to the trial.