A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

As noted above in "Brief Summary".

Inclusion Criteria:

1) Only subjects who are eligible for and have entered into Protocol TDE-PH-304 may
participate in this substudy.

Exclusion Criteria:

1. The subject must voluntarily give informed consent to participate in the substudy.

2. No dose changes to study drug are made within 5 days of the pharmacokinetic
(PK)substudy visits.

3. No additions or deletions to concurrent medications are made within 7 days of the
pharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants are
permitted.

4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior
to the BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure
a trough level of study drug for PK sampling.

5. Subject dosing of study drug on the day of PK sampling must be observed in the clinic
by study personnel.

6. Subject has not experienced a significant loss of blood (> 450 mL) within the last 6
weeks of the pharmacokinetic substudy visit.

7. The subject must not be receiving any CYP 2C8 inducers or inhibitors