Not a scientist, but since the modified protocol includes giving LL SIMULTANEOUSLY with whatever other drug the patients were taking, there may be more SAEs than in the M2M. It’s SOC vs. SOC + LL. Ohm also mentioned that one of the drugs (forget which one) undermines the MOA of LL. Best to ask him.
Fortunately the first patients were just placebo (sugar water) vs. LL. In those we should for sure hit the ball out of the park across the board.