Screening
EVENTS
At the initial screening visit, patients will be classified as either “naïve” or “non-naïve” depending on their use of prohibited medications within the past 6 weeks (42 days). The schedule of events during the initial screening visit and throughout the baseline period (through visit 1) will vary depending on the patient’s classification as either “naïve” or “non-naïve.” Given the known unlicensed use of the racemate (Tanganil™), for all patients, a urine sample will be taken at visit 1 to detect N-acetyl-D-leucine using a validated liquid chromatography mass spectrometry/mass spectrometry method. Provided the level of N-acetyl-D-leucine is below the permitted threshold, the initial screening visit will be confirmed as visit 1 (baseline 1). If a patient classified as “Naïve” unexpectedly tests positive for levels of N-acetyl-D-leucine above the permitted threshold, at the direction of their principal investigator, a run-in wash-out period of 6 weeks (42 days) is requested before they are eligible to return for a repeat visit 1. Patients who fail two urine N-acetyl-D-leucine tests (e.g., visit 1 and repeat visit 1) are ineligible for the study.