after joining the study, the patient is assigned by a computer system to receive either odevixibat or a matching placebo. the assignment is double‑blind, meaning neither the patient nor the study staff knows which treatment is given.

a series of evaluations is performed before the first dose. these include a physical examination, collection of medical history, blood tests for total bilirubin, serum bile acids, vitamins and lipids, and an abdominal ultrasound. the purpose is to document the patient’s condition at the start of the trial.

the patient begins taking one oral capsule each day. the dose is calculated as 120 µg per kilogram of body weight. the capsule is taken with food and the schedule is maintained for up to 104 weeks.

the patient continues the once‑daily capsule throughout the treatment period. consistency is important; missed doses should be avoided.

clinic visits are planned at week 13, week 26, week 52, and week 104. at each visit the patient undergoes blood tests to measure total bilirubin and serum bile acid levels, a physical examination, and an abdominal ultrasound. these assessments monitor the effect of the medication and the safety of the patient.

the visits also provide an opportunity to discuss any side effects or concerns with the study physician.

throughout the trial the patient is asked to report any new symptoms or adverse events. the study team records these events and may perform additional laboratory tests or imaging if needed.

if the patient experiences a liver transplant or death, the treatment period ends for that individual and the event is recorded as the primary outcome of the study.

at week 104 the patient completes the last set of evaluations, which include the same laboratory tests and imaging performed at earlier visits. the results determine whether the patient remained alive without a liver transplant during the 104‑week period.