Table 1.

Schedule of measurements

Assessment	Screening	Placebo run-in D-3, D-2, D-1	Week 0	Week 2	Week 11 D-3, D-2, D-1	Week 12	Week 14	Week 23 D-3, D-2, D-1	Week 24
Informed consent	x
Demography	x
Medical history	x		x
Medical examination	x
Concomitant medications	x		x	x		x	x		x
Inclusion/exclusion checks	x		x
Height and weight*	x		x			x			x
Clinic BP†	x		x			x			x
Home BP‡		x			x			x
ECG	x
Waist and hip circumference	x								x
Urinalysis	x		x						x
Blood Tests:
Electrolytes (including bicarbonate)	x		x	x		x	x		x
Glucose (non-fasting)	x
Full-blood count	x					x			x
Lipid profile	x		x			x			x
Uric acid	x					x			x
Ca++	x					x			x
Renin			x			x			x
Pharmacogenetics§			x
HbA1c			x			x			x
Glucose(fast)¶			x			x			x
Insulin¶			x			x			x
OGTT**			x			x			x
Pregnancy serum††	x
Adverse events						x			x
Randomisation			x
Study medication dispensed	x		x			x
Compliance check			x			x			x
Dose force titrated						x

*Height recorded at first visit only.

†Clinic BP will be measured following 10 min rest and recorded in triplicate.

‡Home BP will be measured using the BP device given by clinic at approximately 08.00 and 20:00 on the 4 days before the clinic visit. Patients will be asked to take triplicate reading after 10 min rest and to record the second and third on the proforma provided.

§Pharmacogenetics sample to be taken where specific informed consent has been given. Sampling will typically be at baseline (day 0), but may be at any time later in the study.

¶ That is, baseline sample for OGTT.

**Glucose at 0, 30, 60, 120 min; insulin at 0, 30 min.

††Serum HcG may be replaced by early morning urine specimen for human choriogonadotropin testing.

BP, blood pressure; HbA1c, glycated haemoglobin; OGTT, oral glucose tolerance test.