Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat

Table 1

Design and doses of the 26- and 52-week studies.

Group number	Study period
	N8-GP (IU/kg/fourth day)	Dosing phase		Recovery phase
		Males (n)	Females (n)	Males (n)	Females (n)
1 (control)	0	18 (21)	18 (21)	9 (12)	9 (12)
2	50	18 (21)	18 (21)	0	0
3	150	18 (21)	18 (21)	0	0
4	500	18 (21)	18 (21)	0	0
5	1200	18 (21)	18 (21)	9 (12)	9 (12)

Numbers given in represent number of animals included in the 52-week study.
Note. The PEG doses in the dosed groups were as follows: Group Two: 0.001 mg PEG/kg/dose; Group Three: 0.003 mg PEG/kg/dose; Group Four: 0.01 mg PEG/kg/dose; and Group Five: 0.024 mg PEG/kg/dose.