Literature Supporting Phase III PROTECT Trial

Oral Heparin: Trial Design Rationale

Study Data Supporting 10% Delta for Efficacy

• Percent DVTs Reported

• Bergqvist1 Dahl2 Planes3

• LMWH (10 days) 39% 32% 19%

• LMWH (30 days) 18% 19% 7%

• 1) Bergqvist (NEJM 1996)

• 2) Dahl, (Thrombosis and Hemostasis 1/97)

• 3) Planes, (Chest 8/98)

• (Note: patients in Dahl and Planes studies who were positive for DVT at Day 7 were removed)

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