Variables | Study daysa |
---|---|
Clinical observations | General observations twice daily Cageside observations once daily Observations 1 h ± 15 min postdose Detailed observations (Days 7, 10, 13, 21, 28, 34, 41, 44, 47, 55, 62, 69, 75, 78, 81 and 89) 1 h ± 15 min postdose (on dosing days) |
Body weight | Days 1, 8, 11, 14, 21, 28, 35, 42, 45, 48, 55, 62, 69, 76, 79, 82, 88 and 89 |
Food consumption | Daily |
Physical and neurological examinations | Days 20, 34, 54, 68 and 88 |
Injection sites scoring | Days of injection (predose and 7 to 8 h postdose) and at 24, 48, and 72 h (±1 h) following each injection |
Ophthalmologic examination | Day 88 |
Electrocardiographic examination | 1 h ± 15 min postdose on Days 20 and 88 |
Buccal mucosal bleed times | Days 20 and 88 |
Clinical pathology | Days 21, 55 and 89 |
Bioanalytical collection | Dose cycle 1: On days 1 and 14, samples were collected predose and 1 and 5 h postdose On days 6, 8 and 11, samples were collected 1 and 5 h postdose Dose cycle 3: On days 69 and 82, samples were collected predose and 1 and 5 h postdose On days 74, 76 and 79, samples were collected 1 and 5 h postdose |