{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "High-resistance IMST × six-week resting systolic blood pressure: evidence gaps",
  "language": "en",
  "translation_date": "2026-10-16",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Awaiting user review",
    "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which resting systolic-pressure claim is examined?",
      "needed": "Selected lower resting systolic-pressure claim",
      "role": "Required",
      "role_reason": "This condition connects Selected lower resting systolic-pressure claim with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Selected lower resting systolic-pressure claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: The selected SBP definition, population, time, comparator, original denominators and content review are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What are the original six-week resting-pressure values?",
      "needed": "Baseline and six-week resting SBP by arm",
      "role": "Required",
      "role_reason": "This condition connects Baseline and six-week resting SBP by arm with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Baseline and six-week resting SBP by arm must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Analysis denominators, baseline/follow-up values, measurement conditions, model, definition of ±, adjusted between-group estimate and 95% CI are needed. No new differences or CIs were calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are 9 mmHg and 6 mmHg adjusted between-group effects?",
      "needed": "Within-arm fall, crude difference in changes and adjusted effect",
      "role": "Required",
      "role_reason": "This condition connects Within-arm fall, crude difference in changes and adjusted effect with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Within-arm fall, crude difference in changes and adjusted effect must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: The effect of interest, model, adjustment variables, exact estimate, CI and original result table are needed. The crude difference is not promoted to independent confirmation of efficacy. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Does group-by-time P=.02 provide an exact effect and CI?",
      "needed": "Distinguishing tests, effect estimates and precision",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing tests, effect estimates and precision with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Distinguishing tests, effect estimates and precision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: The test model, interaction/direct contrast, adjusted estimate, CI, prespecified importance threshold and original denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Is diastolic P=.17 the same result?",
      "needed": "Separate resting SBP and DBP endpoints",
      "role": "Required",
      "role_reason": "This condition connects Separate resting SBP and DBP endpoints with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Separate resting SBP and DBP endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: DBP measurement conditions, original arm values, denominators, effects, CIs, prespecified hierarchy and original analysis tables are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are ambulatory and 24-hour pressure equally established?",
      "needed": "Resting versus ambulatory measurement conditions",
      "role": "Required",
      "role_reason": "This condition connects Resting versus ambulatory measurement conditions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Resting versus ambulatory measurement conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Ambulatory measurement/valid time, 24-hour/day-night definitions, denominators, between-group values, CIs and detailed DBP tables are needed. P=.07 does not establish zero effect or equivalence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Was the actual control low-resistance sham?",
      "needed": "High resistance versus 15% low-resistance sham",
      "role": "Required",
      "role_reason": "This condition connects High resistance versus 15% low-resistance sham with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for High resistance versus 15% low-resistance sham must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual resistance/exposure, device, masking, concurrent care, denominators and direct contrasts by arm are needed. The effect of low resistance versus no intervention is not established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Which middle-aged and older adults were studied?",
      "needed": "Ages 50–79 and above-normal blood-pressure eligibility",
      "role": "Required",
      "role_reason": "This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Ages 50–79 and above-normal blood-pressure eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original eligibility, screening, baseline SBP, medication, sex, disease, arm baselines and subgroup denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What do 38 randomized, 36 analyzed and 18 per arm mean?",
      "needed": "Allocation, analysis populations, completers and original denominators",
      "role": "Required",
      "role_reason": "This condition connects Allocation, analysis populations, completers and original denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Allocation, analysis populations, completers and original denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Arm-specific allocation, completion/analysis flow, exclusions, missingness, ITT/effect of interest and valid blood-pressure/FMD denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What do the six-week training numbers identify?",
      "needed": "Study-exposure duration, frequency and resistance",
      "role": "Required",
      "role_reason": "This condition connects Study-exposure duration, frequency and resistance with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Study-exposure duration, frequency and resistance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original methods, device/resistance measurement, actual adherence/exposure, comparator and denominators are needed. Exposure numbers are preserved without becoming medication-replacement or training instructions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are adherence and persistence after six weeks verified?",
      "needed": "Adherence statements and follow-up/persistence boundaries",
      "role": "Required",
      "role_reason": "This condition connects Adherence statements and follow-up/persistence boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Adherence statements and follow-up/persistence boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Adherence records, actual exposure, attrition, post-training follow-up duration/denominators, between-group effects and CIs are needed. No new maintenance methods or sustained effects are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is approximately 45% FMD an SBP or event effect?",
      "needed": "Relative FMD change and a separate surrogate",
      "role": "Required",
      "role_reason": "This condition connects Relative FMD change and a separate surrogate with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Relative FMD change and a separate surrogate must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original FMD values, measurement, denominators, between-group effects, CIs, timing and actual clinical-event data are needed. No new percentage-point or risk-reduction calculations are made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How far are registration and prior SBP endpoints verified?",
      "needed": "NCT03266510 and historical preregistration statements",
      "role": "Required",
      "role_reason": "This condition connects NCT03266510 and historical preregistration statements with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for NCT03266510 and historical preregistration statements must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Initial registration/change dates, original protocol, SAP, SBP/DBP/ambulatory-pressure/FMD hierarchy and analysis populations are needed. Historical preregistration statements and current reading are distinguished. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Does short-term SBP establish clinical events or medication replacement?",
      "needed": "Surrogate, cardiovascular-event and medication-replacement boundaries",
      "role": "Required",
      "role_reason": "This condition connects Surrogate, cardiovascular-event and medication-replacement boundaries with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Surrogate, cardiovascular-event and medication-replacement boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct clinical-event definitions, follow-up, denominators, CIs and direct medication comparisons are needed. No new risk effects or treatment-replacement instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are clinical importance and effects in other settings verified?",
      "needed": "Between-group CIs, clinical importance and applicability",
      "role": "Required",
      "role_reason": "This condition connects Between-group CIs, clinical importance and applicability with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Between-group CIs, clinical importance and applicability must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Between-group estimates, CIs, prespecified importance thresholds and direct trials/exposure in the same intervention, comparator and population are needed. No new grades or independent-replication certification are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are the same report, trial and participants counted twice?",
      "needed": "Shared parent/subclaim sheets and Craighead report",
      "role": "Required",
      "role_reason": "This condition connects Shared parent/subclaim sheets and Craighead report with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Shared parent/subclaim sheets and Craighead report must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read?",
      "needed": "Distinguishing the stored summary from external originals",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing the stored summary from external originals with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Distinguishing the stored summary from external originals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Where are bibliography and registration identifiers recorded?",
      "needed": "PMID, PMCID, DOI and the evidence-item NCT",
      "role": "Required",
      "role_reason": "This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for PMID, PMCID, DOI and the evidence-item NCT must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are historical bilingual checks the current review?",
      "needed": "Original bilingual wording and historical verification scope",
      "role": "Required",
      "role_reason": "This condition connects Original bilingual wording and historical verification scope with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Original bilingual wording and historical verification scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are subclaim values separated from parent scores and axes?",
      "needed": "Original subclaim grade/note and absent score, status and axes",
      "role": "Required",
      "role_reason": "This condition connects Original subclaim grade/note and absent score, status and axes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Original subclaim grade/note and absent score, status and axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are the evidence date and production date distinguished?",
      "needed": "Original evidence date, correction and deliberation records",
      "role": "Required",
      "role_reason": "This condition connects Original evidence date, correction and deliberation records with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Original evidence date, correction and deliberation records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are public funding and company-related dimensions separated?",
      "needed": "Funding, product support, employee authors and analysis/reporting roles",
      "role": "Required",
      "role_reason": "This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Funding, product support, employee authors and analysis/reporting roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are randomization, masking, measurement and selective reporting detailed?",
      "needed": "Sham-controlled design, bias and prior plans",
      "role": "Required",
      "role_reason": "This condition connects Sham-controlled design, bias and prior plans with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Sham-controlled design, bias and prior plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are actual exposure, adherence and concurrent care verified?",
      "needed": "Study identification versus actual exposure and cointerventions",
      "role": "Required",
      "role_reason": "This condition connects Study identification versus actual exposure and cointerventions with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Study identification versus actual exposure and cointerventions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are possible harms separated from observed event counts?",
      "needed": "Original caution statements and actual harm collection/denominators",
      "role": "Supplementary",
      "role_reason": "This condition connects Original caution statements and actual harm collection/denominators with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Original caution statements and actual harm collection/denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are long-term, rare harms and applicability verified?",
      "needed": "Six-week selected adults versus long-term harms",
      "role": "Supplementary",
      "role_reason": "This condition connects Six-week selected adults versus long-term harms with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Six-week selected adults versus long-term harms must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Which materials would trigger an update?",
      "needed": "Separating originals, applied conditions, observations and verdict changes",
      "role": "Required",
      "role_reason": "This condition connects Separating originals, applied conditions, observations and verdict changes with the selected resting-SBP question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.",
      "application_exception": "Preserve original numbers and study exposure only. Distinguish the 9 mmHg within-arm fall and 6 mmHg crude difference from adjusted between-group effects/CIs, resting SBP from DBP/ambulatory pressure/FMD/cardiovascular events, and 38 randomized from 36 analyzed. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.",
      "criterion": "Material for Separating originals, applied conditions, observations and verdict changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished. This records needed materials; no new research was executed."
    }
  ]
}