- Male and or female subjects between the ages of 18-78 years
- Subject has clinical signs of IEM
- Minimum BMI 17.5kg/m2 and total body weight >50kg
- Other severe pain conditions, e.g. rheumatologic, that may impair subject's
self-assessment of pain due to IEM.
- Evidence of clinically significant hypertension, clinically significant hematological,
dermatological, renal, endocrine (except diabetes mellitus), pulmonary,
gastrointestinal, cardiovascular, hepatic, neurological (other than IEM), or allergic
disease (including drug allergies but excluding untreated asymptomatic seasonal
- Subjects with severe obesity.