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. 2018 Dec 19;8(12):e021038. doi: 10.1136/bmjopen-2017-021038

Table 1.

Time schedule of enrolment, interventions, assessments and visits for participants

Assessment Screening and randomisation visits Follow-up visits Unscheduled
Screening period (Baseline) Randomisation Follow-up 1 Follow-up 2 Follow-up 3 Follow-up 4 Follow-up 5 Follow-up 6 Follow-up 7 Follow-up 8 Follow-up 9 (Final) Premature discontinuation
Week
−4 to −1
Week
0
Month 3 Month 6 Month 12 Month
18
Month 24 Month 30 Month 36 Month 42 Month 48
Selection criteria X X
Informed consent X
Clinical history X
Physical examination X
BP measures Group 1 Office BP X X X X X X X X X X X X
Home BP X X X X
24 hours ABPM X X X X X X
Group 2 Office BP X X X X X X X X X X X X
Home BP X X X X
24 hours ABPM X X X X X X X X X X X
Blood sample for serum creatinine X X
Blood sample for serum creatinine, glucose, HbA1c, uric acid, Na+, K+, lipids X X X X X X
ECG X X X X X X X
Echocardiogram X X X X X X
Urine sample for microalbuminuria and albumin:creatinine ratio X X X X X X X
Ascertain achievement of BP control/adjust antihypertensive treatment if needed X X X X X X X X X X X
Registration of antihypertensive therapy X X X X X X X X X X X X
Registration of concomitant medication X X X X X X X X X X X X
Adverse events/safety evaluation X X X X X X X X X X
Blood sample for biobank creation X X

ABPM, ambulatory blood pressure monitoring; BP, blood pressure; HbA1c, glycated haemoglobin.