Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial

Table 1 Timing of outcome assessments

Timepoint	Enrolment and allocation	Treatment phase 1		Washout phase		Treatment phase 2
Timepoint	0 day	1–4 weeks	4th week	5–6 weeks	6th week	7–10 weeks	10th week
HBPM	X	X	X	X	X	X	X
OBPM	X		X		X		X
Biochemistry results
Electrolyte	X		X				X
FBG	X		X				X
Renal function	X		X				X
Liver function	X		X				X
Urine routine	X		X				X
Tests
ECG	X		X				X
ABPM	X		X		X		X

ABMP ambulatory blood pressure monitoring, ECG electrocardiogram, FBG fasting blood-glucose, HBPM home blood pressure measurement, OBPM office blood pressure measurement

ISSN: 1745-6215