6 ADVERSE REACTIONS Most common adverse reactions (≥1%) are: headache and application site pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact EPI Health, LLC at 1-800-499-4468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The overall safety of SITAVIG was assessed in 378 adult subjects having at least 4 herpes labialis episodes the previous year. One randomized, double-blind, placebo controlled trial was conducted in patients with recurrent herpes labialis (cold sores). In this trial, 378 HSV infected subjects used SITAVIG as a single dose, and 397 subjects used placebo. Selected treatment emergent adverse events without regard to causality and reported in at least 1% of patients can be seen in Table 1. Table 1: Selected Treatment Emergent Adverse Events reported in at least 1% of patients Event SITAVIG N = 378 Placebo N = 397 Nervous System Disorders Headache 3% 3% Dizziness 1% 1% Lethargy 1% 0 Gastrointestinal system Disorders Gingival Pain 1% 0.3% Aphthous Stomatitis 1% 0 Administration Site Conditions Application Site Pain 1% 1% Application Site Irritation 1% 0 Skin and Subcutaneous Disorders Erythema 1% 0.3% Rash 1% 0.3% The treatment emergent adverse events considered related to treatment that occurred in greater than or equal to 1% of patients included headache (1% SITAVIG vs. 2% placebo) and application site pain (1% both arms). There was no discontinuation of SITAVIG due to adverse drug reactions. Most treatment related adverse events were mild or moderate in severity. One report of headache from both treatment arms was classified as severe.