Table 2.

Most common adverse events.

Most common AEs	TTX	Placebo
Nausea	68% (10% severe)	23% (2% severe)
Dizziness	61% (4% severe)	18% (0% severe)
Oral hypoesthesia	61% (0% severe)	9% (0% severe)
Hypoesthesia	48% (0% severe)	10% (0% severe)
Oral paresthesia	44% (0% severe)	2% (0% severe)
Vomiting	34% (3% severe)	8% (0% severe)
Injection site irritation	52% (6% severe)	53% (7% severe)
Serious adverse events (n = 12)	6 patients	3 patients
SAEs related to TTX (after unblinding)	5 events from 3 subjects: ataxia (2), neurotoxicity (1), nystagmus (1), and aspiration pneumonia (1)

Statistical analyses of safety endpoints were descriptive only.