Table 1 Safety variables recorded and samples collected during the in-life phase

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