Table 1

Schedule of study procedures

			T+2 week	T+4 weeks
Time	Pre T0 At each recruitment site	T0 Randomisation/baseline*	Dose titration—40/80 mg arms (dose given 40 mg)	Dose titration for 80 mg arm (dose given 80 mg)	T+12 weeks Follow-up	T+24 weeks Follow-up	T+48 weeks End of treatment	Premature withdrawal of consent
Database search to identify potential participants or clinic list review	Х
Information sheet provided to patient	X
Signed informed consent		Х
Assessment of eligibility criteria by a medically qualified person		Х
Review of medical history (including collection of most recent blood test results for urea and electrolytes, eGFR, liver function, diabetes screening, etc		Х†					X	Х
Review of concomitant medications		Х	Х	Х	Х	Х	Х	Х
Urine pregnancy test		Х			X	X
Randomisation		Х
Study intervention		Х	Х	Х	Х	Х
Compliance with study intervention—patient diaries and pill counting			X	X	Х	Х	Х
Physical examination—complete		Х
Physical examination—symptom-directed			Х	Х	Х	Х	X	Х
Height		Х
Weight		Х			Х	Х	Х	Х
Waist/thigh circumference		Х			Х	Х	Х	Х
Heart rate, blood pressure		Х	Х	Х	Х	Х	Х	Х
Collection of 3 fasting blood samples for bioanalysis		Х			Х	Х	Х	Х
Collection of urine sample		X			X	X	X	X
Assessment of adverse events			Х	Х	Х	Х	Х	Х
Consent for substudy		X
MRI/MRS scan for substudy		X				X

(X)—As indicated/appropriate.
*Baseline assessment and randomisation visit should be within 30 days of the patient giving consent.
†Liver function and diabetes screening result only to be collected at baseline.
eGFR, estimated glomerular filtration rate; MRS, MR spectroscopy.