Table 2

Schedule of visits, examinations and procedures

	Year 1										Year 2				Year 3			Year 4			Year 5
Assessments	Screen	Random	Surgery*	First until third PO	W 1	W 4	M 3	M 6	M 9	M 12	M 15	M 18	M 21	M 24	M 28	M 32	M 36	M 40	M 44	M 48	M 52	M 56	M 60
Informed consent	X
Medical history	X
Physical examination	X							X		X		X		X	X	X	X	X	X	X	X	X	X
Medical assessment	X	X	X	X	X*	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant medication	X	X		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Inclusion/exclusion criteria	X	X
Randomisation		X
Adverse events		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Nerve conduction studies	X							X		X		X		X	X	X	X	X	X	X	X	X	X
Nutritional assessment		X			X	X	X	X	X	X	X	X	X	X	X		X	X		X	X		X
SF-36, IPSS and OAB-Qsf	X									X				X			X			X			X
Urinary diary	X						X	X		X				X			X			X			X
Serum pregnancy test	X
CBC	X									X		X		X			X			X			X
AST/ALT	X									X				X			X			X			X
Amylase	X							X†				X†			X			X			X
Sodium and potassium	X
Urea and creatinine	X						X	X		X		X		X	X	X	X	X	X	X	X	X	X
PT and aPPT	X
Lipids	X							X		X		X		X	X		X	X		X	X		X
Fasting plasma glucose				X	X*	X	X		X		X		X		X	X	X	X	X	X	X	X	X
HbA1c	X						X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Microalbumin and creatinine	X							X		X		X		X	X		X	X		X	X		X
Iron and ferritin	X							X		X				X			X			X			X
Calcium, PTH and vitamin D	X							X		X		X		X			X			X			X
Folic acid	X							X						X			X			X			X
Vitamin A, B₁ and B₁₂	X							X				X		X			X			X			X
Anti-GAD	X
PSA	X
PCR			X				X*	X*		X*		X*		X*	X*		X*	X*		X*	X*		X*
HIV test	X
MMTT	X							X		X		X		X	X		X	X		X	X		X
Urine sample (DNA)		X						X		X				X			X			X			X
Urinalysis	X									X				X			X*			X			X
Chest X-ray	X
Abdominal ultrasound	X
ECG	X
Echocardiogram	X																						X
Upper digestive endoscopy		X
Elastrography ultrasound		X						X		X					X			X			X
Detailed eye examination		X						X		X		X		X
Vital signs	X	X	X	X	X*	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Weight	X			X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Height	X
Dispensing drugs	X		X	X	X*	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
RYGB			X
Glucose monitoring					X*	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

*Procedure exclusive for surgical arm.
†Procedure exclusive for clinical arm.
ALT, serum glutamic-pyruvic transaminase; aPPT, activated partial thromboplastin time; CBC, complete blood count; GAD, glutamic acid decarboxylase; HbA1c, glycated haemoglobin; IPSS, nternational Prostate Symptom Score; MMTT, Mixed Meal Tolerance Test; OAB-Qsf, Overactive Bladder Questionnaire Short Form; PO, orally; PT, prothrombin time; PSA, prostate-specific antigen; PTH, parathyroid hormone; RYGB, Roux-en-Y gastric bypass; SF-36, 36-item Short Form Health Survey.