* female patients who are pregnant or breastfeeding. * participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent. * patients with impaired hepatic or renal function. * subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.

* female patients who are pregnant or breastfeeding. * participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent. * patients with impaired hepatic or renal function. * subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.

- female patients who are pregnant or breastfeeding. - participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent. - patients with impaired hepatic or renal function. - subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.

- female patients who are pregnant or breastfeeding. - participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent. - patients with impaired hepatic or renal function. - subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.