Table 2

Clinical pathology and histology parameters.

Preliminary margin-of-safety topical (Study #1) Regulatory margin-of-safety topical (Study #2) Regulatory oral tolerance (Study #3)
Hematology
 RBC (red blood cell count)
 WBC (white blood cell count, absolute and differential)
 HGB (hemoglobin concentration)
 HCT (hematocrit)
 Platelet count
 MCV (mean corpuscular volume)
 MCH (mean corpuscular hemoglobin)
 MCHC (mean corpuscular hemoglobin concentration)
 Reticulocytes (% and absolute)
 LUC (large unstained cell)
 RDW (red cell distribution width)
 Platelet estimate
 RBC morphology
Serum biochemistry
 Total Protein
 Albumin
 Globulin (calculated)
 Total bilirubin
 Blood urea nitrogen
 Creatinine
 ALT (alanine aminotransferase)
 ALP (alkaline phosphatase
 AST (aspartate aminotransferase)
 GGT (gamma glutamyl transferase)
 Glucose
 Total cholesterol
 Calcium
 Chloride
 Phosphorus
 Potassium
 Sodium
 Triglycerides
 Magnesium
 Appearance (e.g. degree of hemolysis, lipemia, icterus)
Coagulation factors
 PT (prothrombin time)
 Fibrinogen
 APTT (activated partial thromboplastin time)
Urinalysis
 SG (specific gravity)
 pH
 URO (urobilinogen)
 COL (color)
 CLA (clarity)
 PRO (protein)
 GLU (glucose)
 KET (ketones)
 BIL (bilirubin)
 Nitrite
 BLD (occult blood)
 Microscopy of sediments (crystals, RBC, WBC, epithelial cells)
Histology
 Gross lesions (when applicable)
 Heart
 Kidneys (2)
 Liver (sections of two lobes)
 Spleen
 Thymus
 Lungs (including bronchi)
 Skin from application site
 Skin from abdomen
 Skin with mammary gland
 Adrenals (2), aorta, bone with marrow, femur, sternum, bone marrow smear, brain, cervix, eyes with optic nerves (2), gallbladder, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, lymph nodes (mandibular, mesenteric, prescapular (2)), ovaries with oviducts (2), pancreas, sciatic nerve, peyer’s patches, pituitary, prostate, mandibular salivary gland (2), skeletal muscle (femur rectoris), spinal cord (cervical, thoracic, lumbar), testes with epididymis (2), thyroids with parathyroids (2), tongue, trachea, ureters, urinary bladder, uterus, vagina

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