You will learn more about the study. If you decide to take part, you will need to sign the Informed Consent Form.

Your study doctor will examine you (in the clinic or your home or other preferred location by a home healthcare professional), perform tests, and ask questions to find out if you are eligible to take part in the study. You will also speak with a research dietitian.

The screening period includes a 6-day diet run-in when you will initiate the study diet designed by you and your study dietitian. The diet run-in starts one week before receiving the study drug for the first time and continues through the Follow-Up Visit.

The screening period also includes a baseline visit the day before your first dose of study drug. You will have tests completed in the clinic (or in your home or other preferred location by a home healthcare professional) and study entry criteria reviewed. Any changes in your health will be updated.

You will receive the study drug up to 3 times a day with food. Every day or every few days you will receive a higher dose of the study drug than the previous day(s). There will be a total of 3 dose increases (4 doses) over a total of 15 days.

You will have tests done by a study staff member in the clinic or in your home or other preferred location by a home healthcare professional, on Day 1, Day 7, Day 14, and Day 15. In addition, you will be contacted by telephone to talk with a study team member approximately 3 times per week throughout the study, through the Follow-Up Visit.

You will have tests done by a study staff member in the clinic or in your home or other preferred location by a home healthcare professional. You will be asked some questions about your health. You will be asked to report any changes in your health to your study doctor through the End of Study (approximately 2 weeks following the Follow-Up Visit).

You will be contacted by telephone to talk about how you are feeling and discuss any changes in your health or medications.