Adverse events.

Study visits during the placebo and vaccine phases are identical. Placebo injections consisted of vaccine vehicle only. All adverse events are Grade 1 unless otherwise specified. There were no vaccine related serious adverse events. The only statistically significant adverse event was the number of patients having injection site reactions between Arm 1 vaccine phase and Arm 2 pre-vaccine placebo phase (p = 0.001, Fisher's exact test). All other adverse events listed are not statistically significant (p≥0.2 in all cases, Fisher's exact test) between Arm 1 vaccine phase and Arm 2 pre-vaccine placebo phase.