AE and SAE profile:
"In the allograft group, there were 66 total events (29.8% of 141 patients) compared
to 5 total events (13.2% of 38 patients) in the saline group. There was one total event in the NSM group (2.6% of 39 patients)"
"The allograft group had a total of 11 SAEs (3.5% of 141 patients) while there were no serious events in the saline or NSM groups, and one event (2.6% of patients) in the crossover group (P = 0.832) (Table 2). Of the 11 SAEs in the allograft group, 6 were considered possibly related to treatment and/or procedure, including pain, back
pain, bacteremia, and osteomyelitis."
Not sure if operator dependent but gives me pause.