TABLE 2.
Rhesus macaques | Total Possible | Implant D (0.35 mg/day) | Implant D [2x] (0.7 mg/day) |
---|---|---|---|
Observations a | Score | 84 days | 140 days |
Local reactivity Score | |||
Grade 0 | 23% (14/62) | 50% (57/114) | |
Grade 1-2 | 63% (39/62) | 40% (46/114) | |
Grade 3-4 | 14% (9/62) | 10% (11/114) | |
Fibrosis b | 5 | 1.3 ± 0.6 | 1.7 ± 1.2 |
Inflammatory cells | |||
Polymorphonuclear cells | 5 | 3.3 ± 1.2 | 1.3 ± 0.6 |
Lymphocyte cells | 5 | 2.7 + 0.6 | 2.3 ± 0.6 |
Macrophages | 5 | 2.7 ± 1.2 | 2 + 1 |
Plasma Cells | 5 | 2.3 ± 0.6 | 2 ± 1 |
Observations were graded as the following: 0 = None; 1 = Slight; 2 = Well-defined; 3 = Moderate; 4 = Severe.
Scores recorded for lymphocytes, plasma cells, histiocytes/macrophages, polymorphonuclear cells, fibrosis, proliferating fibroblasts, and acute hemorrhage in the subcutaneous tissue (0–5 scale). Mean (+SD) score from the four dermal sections (cranial, medial, caudal, lateral) submitted for histopathology and rated as the following: 0 = None; 1 = Rare; 2 = Moderate/scattered; 3 = Moderate; 4 = Moderate to marked; 5 = Abundant/extensive with 5 being the highest maximum score.