TABLE II

Visual Inspection Results from the Freeze-Thaw Experiments: Number of Vials Containing Lamellae Observed during the 1st and 2nd Inspections, and the Cumulative Counts. N/A - Not Applicable Because the 1st Inspection Was Not Performed

Study ArmsAntibody Drug Product VialsPlacebo Vials
ABCDEFGH
Brief Description−30 °C → 5 °C, 2 cycles−30°C → 5 °C, 2 cycles−70 °C → 5 °C, 2 cycles−70 °C → 5 °C, 2 cycles−30 °C → 5 °C → −70 °C → 5 °C−30 °C → −70 °C → 5 °C−30 °C → 5 °C, 2 cycles−70 °C → 5 °C, 2 cycles
Number of Lamellae Vials1st Inspection0N/A11N/AN/AN/A0N/A
2nd Inspection0023017503
Cumulative00133017503