Table 6.
Validation results.
| Protocol requirements | Range, n | Pass or fail | |||||||||
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<5 mmHg | <10 mmHg | <15 mmHg |
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| Part 1 (N=186a) |
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Required (2 of 3) | At least 137 | At least 163 | At least 180 |
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Achieved differences |
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Systolic blood pressurea | 120 | 147 | 169 | Fail | |||||
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Diastolic blood pressurea | 159 | 180 | 186 | Pass | |||||
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Required (all) | At least 122 | At least 152 | At least 175 |
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Achieved differences |
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Systolic blood pressure | 120 | 147 | 169 |
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Diastolic blood pressure | 159 | 180 | 186 |
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| Part 2 (N=62a) |
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Required | At least 45 |
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Fail | ||||||
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Achieved |
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Systolic blood pressure | 43 | —b | — |
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Diastolic blood pressure | 10 | — | — |
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Allowed | At most 6 |
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Fail | ||||||
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Achieved |
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Systolic blood pressure | 54 | — | — |
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Diastolic blood pressure | 5 | — | — |
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| Grade 3 (final result)—must pass all of parts 1 and 2 |
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Fail | |||||||
aThese reflect the number of readings and participants included in the study when recruitment was stopped.
bNot applicable.