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. 2018 Aug 9;7(8):e10516. doi: 10.2196/10516

Table 1.

Schedule and procedures during patient visits to the participating center.

Procedure Enrollment phase (12 months) Experimental phase (12 months) Follow-up (6 months)
Preliminary visit (369 to 3 days before the experimental phase) First medical visit (day 0) Hemodialysis sessions (approximately every 3 days) Every 30 days Weeks 13, 26, 39 and 52 Hemodialysis sessions (every 30 days)
Informed consent form Xa




Physical exam/medical history and medication review X




Inclusion/Exclusion X




Collection of a blood sampleb
X

X
Randomization
X



Patients’ meeting with the study team and oral training about compliance to treatment
X
X

Provision of the necessary number of pills (on a monthly basis)
X
X

Patients’ training focused on compliance (short educative video)

X


Counting of returned pills


X

Blinding assessment (questionnaire)


X

Measurement of primary and secondary outcomesc during consultations with a nephrologist and a cardiologist
X

X
Assessment of later bleeding adverse events




X

aX indicates the time at which each procedure will occur.

bAssessment of the hematocrit, hemoglobin concentration, and platelet hyperreactivity profile.

cNumber of events for cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis, and assessment of major and minor bleeding using the Thrombolysis in Myocardial Infarction scale.