- Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
- If female, patient is post-menopausal, surgically sterilized, or willing to use two
acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide) throughout the study and
for 3 months from the end of the study. (A condom alone is not considered an
acceptable method of birth control.)
- Patient is, in the opinion of the investigator, willing and able to comply with the
investigational product regimen and all other study requirements.
- Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
- Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs),
defined as greater than 3 to 4 times/month. The following NSAIDs are allowed:
acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone,
naproxen, nimesulide, piroxicam, and sulindac.
- If female, patient is pregnant or breast feeding.
- Clinically significant medical condition that, in the opinion of the investigator,
would place the patient at an increased risk to participate in the study.
- The patient has received a liver or heart transplant prior to enrollment.