ADVERSE REACTIONS The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months. Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinical trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups. Table 3 Adverse events (frequency ≥ 1% for the PerioChip group) reported from 2 five-center U.S. clinical trials PerioChip Total N = 225 PerioChip Total N = 225 PerioChip Total N = 222 PerioChip Total N = 222 N % N % All patients with Adverse Events 193 85.8 189 85.1 Toothache* 114 50.7 92 41.4 Upper resp tract infection 64 28.4 58 26.1 Headache 61 27.1 61 27.5 Sinusitis 31 13.8 29 13.1 Influenza-like symptoms 17 7.6 21 9.5 Back pain 15 6.7 25 11.3 Tooth disorder** 14 6.2 15 6.8 Bronchitis 14 6.2 7 3.2 Abscess 13 5.8 13 5.9 Pain 11 4.9 11 5.0 Allergy 9 4.0 13 5.9 Myalgia 9 4.0 9 4.1 Gum hyperplasia 8 3.6 5 2.3 Pharyngitis 8 3.6 5 2.3 Arthralgia 7 3.1 13 5.9 Dysmenorrhea 7 3.1 13 5.9 Dyspepsia 7 3.1 6 2.7 Rhinitis 6 2.7 11 5.0 Coughing 6 2.7 7 3.2 Arthrosis 6 2.7 4 1.8 Hypertension 5 2.2 6 2.7 Stomatitis ulcerative 5 2.2 1 0.5 Tendinitis 5 2.2 1 0.5 * Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity ** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings