Table 2 Primary and secondary analyses
Analyses | Population | Subgroup | Endpoints | Framework |
|---|---|---|---|---|
Primary | ITT | None | Primary | Univariate |
Secondary | PP | None | Primary | Univariate |
| Â | ITT | None | Secondary | Univariate |
| Â | ITT | None | Secondary | Multivariate |
| Â | ITT | Baseline LVMI subgroups (observed median LVMI as the level boundary) | Primary | Univariate |
| Â | ITT | Baseline LVMI subgroups (observed median LVMI as the level boundary) | Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % maximum recommended daily dose of antihypertensives | Multivariate, accounting for subgroup effect and treatment-subgroup interaction, FDR control to account for multiplicity |
| Â | ITT | Baseline intra-dialytic and inter-dialytic blood pressure subgroups (observed mean blood pressure as the level boundary) | Primary | Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction |
| Â | ITT | Baseline intra-dialytic and inter-dialytic blood pressure subgroups (observed mean blood pressure as the level boundary) | Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % max recommended daily dose of antihypertensives | Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction, FDR control to account for multiplicity |
| Â | ITT | Baseline pre-dialysis plasma Na+ ionic activity subgroups (observed median plasma Na+ ionic activity as the level boundary) | Primary | Univariate, accounting for subgroup effect and treatment-subgroup interaction |
| Â | ITT | Baseline pre-dialysis plasma Na+ iIonic activity subgroups (observed median plasma Na+ ionic activity as the level boundary) | Time-averaged blood pressure over months 3, 6, 9 and 12 (intra-dialytic, inter-dialytic), % maximum recommended daily dose of antihypertensives | Univariate, accounting for subgroup effect and treatment-subgroup interaction, and three-way interaction, FDR control to account for multiplicity |
Tolerability | ITT | None | Hypotension event counts | Multivariate, mixed effects, allowing for treatment time interaction |