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 2 Analysis methods for different outcomes

Outcomes	Analysis methods
Primary outcome
Changes in 24-h SBP	Linear mixed-effects model
Secondary outcomes
Changes in 24-h DBP	Linear mixed-effects model
Changes in daytime BP	Linear mixed-effects model
Changes in nighttime BP	Linear mixed-effects model
Changes in morning BP surge	Linear mixed-effects model
Changes in office BP	Linear mixed-effects model
Changes in home BP	Linear mixed-effects model
Changes in heart rate	Linear mixed-effects model
BP control rate	Paired chi-square test
TTR of home BP	Linear mixed-effects model
Safety outcomes
Adverse event	Chi-square tests or Fisher’s exact probability method
Changes in biochemistry results	Linear mixed-effects model
Changes in QT interval	Linear mixed-effects model

BP blood pressure, DBP diastolic blood pressure, SBP systolic blood pressure, TTR time in target range

ISSN: 1745-6215