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. 2020 Aug 20;22(9):1713–1722. doi: 10.1111/jch.13993

TABLE 1.

Follow‐up assessment schedule of the trial

Assessments

● Mandatory

○ If needed

Screening Treatment period At withdrawal
Week 0 Week 4 Week 8 Week 12 Medication‐use evaluation Week 16 Week 20 Week 24
Day1 Day 29 Day 57 Day 85 Day 113 Day 141 Day 169
Scheduled visits 28 d before registration Registration ±14 d ±14 d ±14 d Within 14 d after ABPM at 12 wk ±14 d ±14 d ±14 d Within 14 d after withdrawal
Eligibility
Informed consent
Registration & Randomization
Usage monitoring of
investigational medical device (app)
Baseline characteristics
Examination Subjective
Objective
Physical Height
Weight
BMI
Waist circumference
Physiological functions ABPM
Home BP and HR (awake and bedtime)
Office BP and HR
12‐lead ECG
Epworth sleepiness scale
Laboratory Blood test
Pregnancy test
Urinalysis
Salt intake check sheet
Medication usage
Concomitant medication & treatment
Adverse events