TABLE I

Summary of the Design of the Freeze-Thaw Experiments: Freeze-Thaw Temperature Conditions and Inspection Requirements of the Drug Product and Placebo Samples

Study Arms	Antibody Drug Product (315 Vials Per Arm)						Placebo (315 Vials Per Arm)
Study Arms	A	B	C	D	E	F	G	H
1^st Freeze	−30 °C	−30 °C	−70 °C	−70 °C	−30 °C	−30 °C	−30 °C	−70 °C
1^st Thaw	2–8 °C	2–8 °C	2–8 °C	2–8 °C	2–8 °C	Skip 1st Thaw	2–8 °C	2–8 °C
1^st Inspection (post 1^st freeze-thaw)	Yes	No	Yes	No	No	No	Yes	No
2^nd Freeze	−30 °C	−30 °C	−70 °C	−70 °C	−70 °C	−70°C	−30 °C	−70 °C
2^nd Thaw	2–8 °C	2–8 °C	2–8 °C	2–8 °C	2–8 °C	2–8°C	2–8°C	2–8 °C
2^nd Inspection (post 2^nd freeze-thaw)	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes