Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:
Patient has completed the Month 18 visit of Study Fx-005.
If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.
Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.
Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.
You may not be if
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).
If female, patient is pregnant or breast feeding.
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) \>2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
