{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3001-s0", "verdict_number": "3001", "title": "Combined breathing added to standard care × six-week SBP: evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-18", "criteria_version": "1.1", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Adults with hypertension continued medication and lifestyle management. Mittal has 91 randomized and 68 completed; preserve original 23 withdrawals and 25.3% attrition. Age, baseline pressure, comorbidities and arm allocation/analysis denominators are unverified. Ghiya has a separate 100-participant acute HRV report.", "intervention": "The study added a combined alternate-nostril breathing program preceded by abdominal breathing to standard care. This is not converted into standalone alternate-nostril, other pranayama or combined-yoga effects. Component contributions, actual delivery, instruction and adherence are unverified.", "dose": "Original study identifiers are 2 minutes of abdominal breathing followed by 10 minutes of alternate-nostril breathing, 12 minutes daily for 6 weeks. Actual exposure, adherence and discontinuation are unverified. This plan is not turned into personal breathing procedures, medication reduction/replacement or treatment instructions.", "comparator": "Combined breathing added to standard management versus standard management alone. Actual medication types, doses, changes, lifestyle care and contact/attention controls are unverified. Ghiya's other-pranayama comparator is a separate acute HRV context.", "endpoint": "The selection is final 6-week SBP: breathing 139.14±12.5 versus control 147.79±12.8 mmHg, between-group P<.01. The meaning of ±, denominators, adjusted between-group effects and 95% CIs are unverified. Crude final-value difference -8.65 mmHg is an existing record, not adjusted change, ITT or a personal effect. DBP P>.05 and HRV are separate.", "duration": "Direct SBP context spans 6 weeks; Ghiya is an acute HRV comparison. Post-training persistence, harm follow-up, medication changes and long-term clinical events are unverified. Short-term final values are not extended into long-term effects or treatment replacement.", "excluded_extensions": [ "Transferring final values, crude differences, P or ± into baseline-adjusted effects, 95% CIs, ITT or personal effects", "Extending the combined abdominal-first adjunct into standalone alternate-nostril breathing, other yoga or medication replacement", "Counting DBP, acute HRV or multiple measures from one report as independent 6-week SBP replication", "Turning randomized, completed, withdrawn or other-report participants into unique-participant totals or new calculations", "Turning the CTRI identifier into NCT, verified prospective endpoints or reading registration originals", "Using public/academic support, original C with 50 points or caution as new independence, precision or safety certification", "Creating new numbers, grades, breathing procedures, medication reduction/replacement or treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which 6-week SBP question is selected?", "needed": "Adjunct 6-week SBP claim and boundaries of other outcomes", "role": "Required", "role_reason": "This condition connects Adjunct 6-week SBP claim and boundaries of other outcomes with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Adjunct 6-week SBP claim and boundaries of other outcomes 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: Detailed prospective analyses and endpoint hierarchy for the selected question are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The selected wording is lower 6-week SBP added to standard care. The parent verdict concerns 6-week systolic pressure in treated adults with hypertension; another subclaim concerns DBP/HRV. Preserve the existing selected question without counting new independent replication.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Detailed prospective analyses and endpoint hierarchy for the selected question are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed prospective analyses and endpoint hierarchy for the selected question are unverified." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are selected grade and parent score distinguished?", "needed": "Selected C, original note, absent score/status and parent C with 50 points", "role": "Required", "role_reason": "This condition connects Selected C, original note, absent score/status and parent C with 50 points with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Selected C, original note, absent score/status and parent C with 50 points 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: Selected-question score/status fields are unrecorded. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Selected original grade is C, with a note that final values differed but adjusted effect/CI were unverified. Selected-question score/status are unrecorded. Parent C with 50 points and caution are historical context, not a new subclaim score.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Selected-question score/status fields are unrecorded.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected-question score/status fields are unrecorded." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which adults with hypertension do the 6-week results concern?", "needed": "Treated participants, eligibility, baseline pressure, severity and comorbidities", "role": "Required", "role_reason": "This condition connects Treated participants, eligibility, baseline pressure, severity and comorbidities with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Treated participants, eligibility, baseline pressure, severity and comorbidities 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: Detailed eligibility, baseline risk, recruitment and comorbidity materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original descriptions concern adults with hypertension continuing medication and lifestyle management. Age, baseline SBP, severity, comorbidities, eligibility, exclusions and recruitment characteristics are unverified in the stored summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Detailed eligibility, baseline risk, recruitment and comorbidity materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed eligibility, baseline risk, recruitment and comorbidity materials are needed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How does the combined intervention differ from alternate-nostril breathing alone?", "needed": "Abdominal breathing for 2 minutes before 10 minutes of alternate-nostril breathing", "role": "Required", "role_reason": "This condition connects Abdominal breathing for 2 minutes before 10 minutes of alternate-nostril breathing with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Abdominal breathing for 2 minutes before 10 minutes of alternate-nostril breathing 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: Component contributions and direct standalone alternate-nostril comparisons are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original study describes 2 minutes of abdominal breathing followed by 10 minutes of Nadi Shodhana, explicitly not alternate-nostril breathing alone. Component-specific SBP contributions and direct standalone comparisons are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Component contributions and direct standalone alternate-nostril comparisons are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Component contributions and direct standalone alternate-nostril comparisons are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What original information describes daily exposure and duration?", "needed": "Daily 12-minute, 6-week plan versus actual adherence, discontinuation and assessment", "role": "Required", "role_reason": "This condition connects Daily 12-minute, 6-week plan versus actual adherence, discontinuation and assessment with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Daily 12-minute, 6-week plan versus actual adherence, discontinuation and assessment 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 adherence, discontinuation, exposure records and exposure-specific effects are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records describe adding 12 minutes daily for 6 weeks; the first 2 of 12 minutes were abdominal breathing. Actual days, frequency, adherence, discontinuation and exposure-specific SBP responses are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Actual adherence, discontinuation, exposure records and exposure-specific effects are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual adherence, discontinuation, exposure records and exposure-specific effects are needed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How does addition to standard care differ from standalone treatment?", "needed": "Continued medication/lifestyle care and the combined-breathing comparison", "role": "Required", "role_reason": "This condition connects Continued medication/lifestyle care and the combined-breathing comparison with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Continued medication/lifestyle care and the combined-breathing comparison 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 medication/lifestyle details, changes, common care and attention controls are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Standard management plus breathing versus standard management alone. Original records say medication/lifestyle care continued. Medication types, doses, lifestyle-management details and changes are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Arm-specific medication/lifestyle details, changes, common care and attention controls are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific medication/lifestyle details, changes, common care and attention controls are needed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How do final 6-week SBP values differ from changes?", "needed": "SBP definition, units, final values, baseline, change and measurement", "role": "Required", "role_reason": "This condition connects SBP definition, units, final values, baseline, change and measurement with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for SBP definition, units, final values, baseline, change and measurement 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: Baseline, change, exact measurement and adjustment-model materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original endpoints are 6-week SBP, DBP and HRV over 6 weeks. The selection is SBP; original reader-answer values are final arm values after 6 weeks. Changes, adjustments and measurement details are separately unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline, change, exact measurement and adjustment-model materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline, change, exact measurement and adjustment-model materials are needed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are the stored arm-specific final 6-week SBP statistics?", "needed": "139.14±12.5 versus 147.79±12.8 mmHg, P<.01 and arm identity", "role": "Required", "role_reason": "This condition connects 139.14±12.5 versus 147.79±12.8 mmHg, P<.01 and arm identity with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for 139.14±12.5 versus 147.79±12.8 mmHg, P<.01 and arm identity 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 meaning of ±, arm analysis n, CIs and test/model details are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records give breathing 139.14±12.5 and control 147.79±12.8 mmHg, between-group P<.01. The evidence summary preserves the same result. The meaning of ±, exact arm analysis n and CIs are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The meaning of ±, arm analysis n, CIs and test/model details are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The meaning of ±, arm analysis n, CIs and test/model details are needed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What does -8.65 mmHg represent?", "needed": "Original crude final-value difference versus baseline-adjusted effect", "role": "Required", "role_reason": "This condition connects Original crude final-value difference versus baseline-adjusted effect with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Original crude final-value difference versus baseline-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: Exact CIs, denominators and models for the crude difference are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Existing Korean/English records say the crude final-value difference -8.65 mmHg should not be called baseline-adjusted change. This value comes from original records; it was not newly calculated here.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact CIs, denominators and models for the crude difference are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact CIs, denominators and models for the crude difference are unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are baseline-adjusted between-group effects and 95% CIs verified?", "needed": "Baseline, covariates, adjustment model, between-group effect and 95% CIs", "role": "Required", "role_reason": "This condition connects Baseline, covariates, adjustment model, between-group effect and 95% CIs with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Baseline, covariates, adjustment model, between-group effect and 95% CIs 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: Adjusted effects, 95% CIs, baseline, covariates and analysis models are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original notes/descriptions explicitly leave adjusted between-group effects and 95% CIs unverified. Crude difference -8.65 or between-group P<.01 does not replace them.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Adjusted effects, 95% CIs, baseline, covariates and analysis models are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjusted effects, 95% CIs, baseline, covariates and analysis models are needed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "How do P values differ from effect size and precision?", "needed": "SBP effects, CIs, clinical importance, sample-size plans and denominators", "role": "Required", "role_reason": "This condition connects SBP effects, CIs, clinical importance, sample-size plans and denominators with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for SBP effects, CIs, clinical importance, sample-size plans and 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: Effect intervals, clinical thresholds, prospective plans and sample-size calculations are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Final-SBP between-group P<.01 is preserved. The 95% CI, precise adjusted effect, prospective target and sample-size rationale are unverified; parent precision is unrecorded.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Effect intervals, clinical thresholds, prospective plans and sample-size calculations are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Effect intervals, clinical thresholds, prospective plans and sample-size calculations are needed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What stage does 91 randomized describe?", "needed": "Original allocation of 91 and arm allocation/recruitment/eligibility flow", "role": "Required", "role_reason": "This condition connects Original allocation of 91 and arm allocation/recruitment/eligibility flow with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Original allocation of 91 and arm allocation/recruitment/eligibility flow 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 allocation, recruitment, eligibility and exclusion counts are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal is stored as 91 randomized and 68 completed. Arm allocation n, eligibility, exclusions and recruitment flow are unverified in the summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Arm allocation, recruitment, eligibility and exclusion counts are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm allocation, recruitment, eligibility and exclusion counts are needed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How do completion and 6-week analyses connect?", "needed": "68 completed, arm completion, endpoint analysis n and complete-case definition", "role": "Required", "role_reason": "This condition connects 68 completed, arm completion, endpoint analysis n and complete-case definition with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for 68 completed, arm completion, endpoint analysis n and complete-case definition 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 completion/analysis n, endpoint-specific missingness and complete-case definitions are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original descriptions concern a complete-case analysis after 23 withdrawals. The 68 completed is original n; exact arm-specific 6-week SBP analysis n, DBP/HRV missingness and denominator identity are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Arm completion/analysis n, endpoint-specific missingness and complete-case definitions are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm completion/analysis n, endpoint-specific missingness and complete-case definitions are needed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What original records describe 23 withdrawals and 25.3% attrition?", "needed": "Attrition, arm reasons, timing, baseline risk and data loss", "role": "Required", "role_reason": "This condition connects Attrition, arm reasons, timing, baseline risk and data loss with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Attrition, arm reasons, timing, baseline risk and data loss 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 attrition, reasons, timing and withdrawn participants' baseline/outcome data are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records describe 25.3% attrition and complete-case analysis after 23 withdrawals. These are existing figures, not new calculations. Arm distribution, reasons, baseline differences and timing are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Arm attrition, reasons, timing and withdrawn participants' baseline/outcome data are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm attrition, reasons, timing and withdrawn participants' baseline/outcome data are needed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which intervention effect does the complete-case result estimate?", "needed": "ITT, PP, complete cases, missingness, medication, adherence and sensitivity", "role": "Required", "role_reason": "This condition connects ITT, PP, complete cases, missingness, medication, adherence and sensitivity with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for ITT, PP, complete cases, missingness, medication, adherence and sensitivity 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: ITT/PP, missingness handling, sensitivity, effects of interest and original models are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records identify complete-case analysis and high attrition as limitations. ITT estimates for all 91 participants, imputation, sensitivity, actual-use and adjusted analyses are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "ITT/PP, missingness handling, sensitivity, effects of interest and original models are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT/PP, missingness handling, sensitivity, effects of interest and original models are needed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is known about allocation, concealment and recruitment?", "needed": "Random-sequence generation, concealment, recruitment order, baseline and assessment", "role": "Required", "role_reason": "This condition connects Random-sequence generation, concealment, recruitment order, baseline and assessment with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Random-sequence generation, concealment, recruitment order, baseline and assessment 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: Allocation generation, concealment, recruitment and baseline-balance procedures are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal is stored as a randomized adjunct-to-standard-management trial. Actual generation, concealment, recruitment order, baseline balance and analysis procedures are unverified in the summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Allocation generation, concealment, recruitment and baseline-balance procedures are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation generation, concealment, recruitment and baseline-balance procedures are needed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are participant, instructor and assessor awareness/contact known?", "needed": "Attention/time controls, instruction, contact and measurement/analysis blinding", "role": "Required", "role_reason": "This condition connects Attention/time controls, instruction, contact and measurement/analysis blinding with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Attention/time controls, instruction, contact and measurement/analysis blinding 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: Attention/contact controls, instructors and measurement/analysis blinding materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original comparison is added breathing versus standard management. Contact time, control activities, assessor/analyst allocation awareness and actual blinding procedures are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Attention/contact controls, instructors and measurement/analysis blinding materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Attention/contact controls, instructors and measurement/analysis blinding materials are needed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Can baseline pressure and arm differences be linked to final values?", "needed": "Arm baseline SBP/DBP, medication, risk and baseline handling", "role": "Required", "role_reason": "This condition connects Arm baseline SBP/DBP, medication, risk and baseline handling with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Arm baseline SBP/DBP, medication, risk and baseline handling 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: Baseline SBP/DBP, medication/risk balance and model handling are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records do not call the -8.65 final-value difference baseline-adjusted change. Exact arm baseline SBP, changes, covariates and adjustment details are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline SBP/DBP, medication/risk balance and model handling are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline SBP/DBP, medication/risk balance and model handling are needed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How was 6-week SBP measured?", "needed": "Device, posture, rest, repetitions, setting, time and assessors", "role": "Required", "role_reason": "This condition connects Device, posture, rest, repetitions, setting, time and assessors with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Device, posture, rest, repetitions, setting, time and assessors 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: Measurement devices, settings, repetitions, rest, timing and assessors are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original wording describes 6-week systolic pressure in mmHg. Exact devices, office/home/ambulatory pressure, repeat averages, rest, timing and assessor methods are unverified in the summary.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Measurement devices, settings, repetitions, rest, timing and assessors are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement devices, settings, repetitions, rest, timing and assessors are needed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "How does continued medication differ from actual prescription changes?", "needed": "Arm medication types, doses, changes, adherence, rescue drugs and timing", "role": "Required", "role_reason": "This condition connects Arm medication types, doses, changes, adherence, rescue drugs and timing with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Arm medication types, doses, changes, adherence, rescue drugs and timing 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 medication, doses, adherence, changes and model handling are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records describe an adjunct with medication/lifestyle management continued. Arm medication types, doses, adherence, changes, rescue prescriptions and handling in SBP analyses are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Actual medication, doses, adherence, changes and model handling are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual medication, doses, adherence, changes and model handling are needed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are lifestyle care and other breathing/yoga comparisons distinguished?", "needed": "Standard lifestyle management, exercise, diet, contact and other-intervention boundaries", "role": "Required", "role_reason": "This condition connects Standard lifestyle management, exercise, diet, contact and other-intervention boundaries with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Standard lifestyle management, exercise, diet, contact and other-intervention 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: Lifestyle content, arm changes and adherence to other interventions are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original descriptions say other pranayama or combined-yoga results were not used. Specific standard lifestyle care and changes are unverified; Ghiya's other-breathing comparison is a separate acute HRV context.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Lifestyle content, arm changes and adherence to other interventions are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Lifestyle content, arm changes and adherence to other interventions are needed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are actual breathing exposure and discontinuation linked to analyses?", "needed": "Actual delivery, instruction, adherence, discontinuation, exposure/completion denominators and analysis", "role": "Required", "role_reason": "This condition connects Actual delivery, instruction, adherence, discontinuation, exposure/completion denominators and analysis with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Actual delivery, instruction, adherence, discontinuation, exposure/completion denominators and analysis 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, actual exposure, discontinuation reasons and attrition relationships are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve the original daily 6-week plan, 91 allocated and 68 completed. Actual adherence, instruction, discontinuation reasons and completion-exposure relationships are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Adherence, actual exposure, discontinuation reasons and attrition relationships are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence, actual exposure, discontinuation reasons and attrition relationships are needed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the CTRI identifier separate from a prospective SBP plan?", "needed": "CTRI/2023/11/059625, registration, plans, endpoint hierarchy and timing", "role": "Required", "role_reason": "This condition connects CTRI/2023/11/059625, registration, plans, endpoint hierarchy and timing with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for CTRI/2023/11/059625, registration, plans, endpoint hierarchy and timing 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: Registration contents, prospective endpoints, recruitment/registration dates and plan amendments are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal's original registration wording is CTRI/2023/11/059625. Original descriptions explicitly leave official prospective endpoints unverified. Listing SBP, DBP and HRV does not establish prospective hierarchy. Registration contents, dates and changes were unread this time.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Registration contents, prospective endpoints, recruitment/registration dates and plan amendments are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration contents, prospective endpoints, recruitment/registration dates and plan amendments are needed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How is the null DBP wording preserved?", "needed": "Between-group DBP P>.05 versus SBP, effects, CIs and denominators", "role": "Required", "role_reason": "This condition connects Between-group DBP P>.05 versus SBP, effects, CIs and denominators with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Between-group DBP P>.05 versus SBP, effects, CIs and 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: Exact DBP values, arm denominators, effects, CIs and plans are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal's original results are between-group SBP P<.01 and DBP P>.05. Parent descriptions call DBP null; the other subclaim's original grade is D. Distinguish selected SBP C and retain unverified exact DBP effects/CIs.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact DBP values, arm denominators, effects, CIs and plans are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact DBP values, arm denominators, effects, CIs and plans are needed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How does 6-week SBP differ from main-trial HRV?", "needed": "Mittal HRV measures, units, timing and analyses versus SBP", "role": "Required", "role_reason": "This condition connects Mittal HRV measures, units, timing and analyses versus SBP with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Mittal HRV measures, units, timing and analyses versus SBP 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: HRV measures, units, effects, CIs, timing and denominators are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original descriptions say HRV varied by measure. Endpoints are 6-week SBP, DBP and HRV; the other subclaim note also says HRV varied by measure/study. Specific measures, effects, CIs and analyses are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "HRV measures, units, effects, CIs, timing and denominators are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "HRV measures, units, effects, CIs, timing and denominators are needed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is the 100-participant HRV comparison direct 6-week SBP evidence?", "needed": "Ghiya's other-pranayama acute HRV comparison, original null result and identity", "role": "Required", "role_reason": "This condition connects Ghiya's other-pranayama acute HRV comparison, original null result and identity with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Ghiya's other-pranayama acute HRV comparison, original null result and identity 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: Exact acute HRV measures, effects, CIs, population, denominators and registration are needed. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Ghiya is stored as 100 participants, an acute comparison with another pranayama and null between-group HRV. Original records describe indirect HRV context; the citation note says it is not 6-week pressure replication.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact acute HRV measures, effects, CIs, population, denominators and registration are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact acute HRV measures, effects, CIs, population, denominators and registration are needed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How are reports, populations and endpoints kept from double-counting?", "needed": "Mittal/Ghiya bibliographies, registration and report/trial/cohort links", "role": "Required", "role_reason": "This condition connects Mittal/Ghiya bibliographies, registration and report/trial/cohort links with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Mittal/Ghiya bibliographies, registration and report/trial/cohort links 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: Report/cohort overlap, registration links and unique-participant/trial counts are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal SBP, DBP and HRV are measures from one stored report. Ghiya is another comparator/acute HRV report. Preserve identities without calculating or establishing unique-trial/participant totals or independent 6-week SBP replication counts.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Report/cohort overlap, registration links and unique-participant/trial counts are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/cohort overlap, registration links and unique-participant/trial counts are unverified." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What is the verification level of public/academic support wording?", "needed": "Report-specific support, COI, roles and independence", "role": "Required", "role_reason": "This condition connects Report-specific support, COI, roles and independence with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Report-specific support, COI, roles and independence 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: Support/COI details, involvement, researcher roles and independence materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Mittal is stored as reported public/academic support; Ghiya as academic research. Specific institutions, amounts, design/analysis involvement, COI, instructor/assessor roles and report independence are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Support/COI details, involvement, researcher roles and independence materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support/COI details, involvement, researcher roles and independence materials are needed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Is independent SBP evidence available for the same population, components and duration?", "needed": "Direct follow-up with matching combined adjunct, population, measurements and denominators", "role": "Required", "role_reason": "This condition connects Direct follow-up with matching combined adjunct, population, measurements and denominators with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Direct follow-up with matching combined adjunct, population, measurements and 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: Independent direct evidence for the same question, condition differences and report-family relationships are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original grading describes a short-term SBP signal and says acute HRV was not counted as independent 6-week pressure replication. Independent direct SBP materials matching components, population and duration are unverified within the stored scope.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Independent direct evidence for the same question, condition differences and report-family relationships are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent direct evidence for the same question, condition differences and report-family relationships are needed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does the 6-week effect persist after the program ends?", "needed": "Post-program follow-up, medication, lifestyle care, continuation/discontinuation and pressure", "role": "Required", "role_reason": "This condition connects Post-program follow-up, medication, lifestyle care, continuation/discontinuation and pressure with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Post-program follow-up, medication, lifestyle care, continuation/discontinuation and pressure 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: Post-program follow-up, exposure/treatment changes and sustained SBP materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original verdict identifies short follow-up as a limitation. Post-program pressure, continued/discontinued practice, medication/lifestyle changes and persistence are unverified in the stored summary.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Post-program follow-up, exposure/treatment changes and sustained SBP materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Post-program follow-up, exposure/treatment changes and sustained SBP materials are needed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Does a final-SBP signal answer cardiovascular-event or medication-replacement questions?", "needed": "Pressure surrogates versus separate clinical-event/medication-change comparisons", "role": "Required", "role_reason": "This condition connects Pressure surrogates versus separate clinical-event/medication-change comparisons with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Pressure surrogates versus separate clinical-event/medication-change comparisons 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 long-term clinical-event, medication-change and replacement materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original summaries say this is not evidence of a standalone effect or medication replacement. Short-term final values are not extended into treatment replacement or long-term events. Direct cardiovascular-event/medication-reduction effects are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct long-term clinical-event, medication-change and replacement materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct long-term clinical-event, medication-change and replacement materials are needed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What level of material was actually read?", "needed": "Stored summaries/bibliographies versus external abstracts, full texts, registration and plans", "role": "Required", "role_reason": "This condition connects Stored summaries/bibliographies versus external abstracts, full texts, registration and plans with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Stored summaries/bibliographies versus external abstracts, full texts, registration and 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: External materials were unread; inaccessibility or access failure was not verified either. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The complete stored parent-verdict summary was read and a copy preserved. Mittal/Ghiya bibliographies and report summaries were read; external abstracts, full texts, registration, plans and support materials were unread, with access unattempted.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "External materials were unread; inaccessibility or access failure was not verified either.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External materials were unread; inaccessibility or access failure was not verified either." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How are the original date, production and review separated?", "needed": "Original evidence date, empty correction/deliberation records and historical grade decisions", "role": "Required", "role_reason": "This condition connects Original evidence date, empty correction/deliberation records and historical grade decisions with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Original evidence date, empty correction/deliberation records and historical grade decisions 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: Current content-review and new clinical-verification dates are undetermined. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original evidence date is 2026-09-07; corrections are an empty array and deliberation an empty string. Cross-check applied in the parent verdict is a historical record, not completion of current review.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Current content-review and new clinical-verification dates are undetermined.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Current content-review and new clinical-verification dates are undetermined." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are both original languages' boundaries preserved?", "needed": "Selected claims/notes and combined adjunct, final-value, adjustment and attrition boundaries", "role": "Required", "role_reason": "This condition connects Selected claims/notes and combined adjunct, final-value, adjustment and attrition boundaries with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Selected claims/notes and combined adjunct, final-value, adjustment and attrition 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: Detailed comparison of external papers, Korean/English translations and corrections is unverified. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Selected English wording concerns 6-week SBP added to standard care; its note separates final-value differences from unverified adjusted effects/CIs. Parent English describes combined breathing, addition to medication/lifestyle care, 25.3% attrition and crude-difference boundaries.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Detailed comparison of external papers, Korean/English translations and corrections is unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed comparison of external papers, Korean/English translations and corrections is unverified." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "How are parent axes and absent selected-question fields preserved?", "needed": "B/S/R1/I2/EX/B2, unrecorded precision, original booleans and empty overrides", "role": "Required", "role_reason": "This condition connects B/S/R1/I2/EX/B2, unrecorded precision, original booleans and empty overrides with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for B/S/R1/I2/EX/B2, unrecorded precision, original booleans and empty overrides 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: Preserve absent selected score/status/axes and unverified precision. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Parent axes are B/S/R1/I2/EX/B2, with precision unrecorded. Coprimary split, large hard-outcome trial, no human study and 1st-endpoint failure followed by a positive 2nd endpoint are all false; derived grade is C and override reasons are empty strings. The selected question has no separate score/status/axes.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Preserve absent selected score/status/axes and unverified precision.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preserve absent selected score/status/axes and unverified precision." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "How were harms defined and collected?", "needed": "Original hyperventilation, dizziness and distress warnings versus actual events", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Original hyperventilation, dizziness and distress warnings versus actual events with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Original hyperventilation, dizziness and distress warnings versus actual events 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: Harm definitions, collection procedures, assessors and actual event tables are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original safety is caution, with warnings about hyperventilation, dizziness and distress. Actual counts, active/passive collection, assessors and original harm tables are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Harm definitions, collection procedures, assessors and actual event tables are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm definitions, collection procedures, assessors and actual event tables are needed." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are exposure, discontinuation, symptoms and follow-up timing known?", "needed": "Actual exposure, symptom/discontinuation timing and during/post-study follow-up", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Actual exposure, symptom/discontinuation timing and during/post-study follow-up with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Actual exposure, symptom/discontinuation timing and during/post-study follow-up 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: Harm timing, recurrence, recovery and later follow-up are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The daily 6-week exposure plan is preserved. Symptom onset, discontinuation timing, recurrence, recovery and later harm follow-up are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Harm timing, recurrence, recovery and later follow-up are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm timing, recurrence, recovery and later follow-up are needed." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Were harms compared with standard care using the same methods?", "needed": "Arm harm collection, observation windows, cointerventions, discontinuation and comparative tables", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Arm harm collection, observation windows, cointerventions, discontinuation and comparative tables with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Arm harm collection, observation windows, cointerventions, discontinuation and comparative tables 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: Comparative harms, matching collection/follow-up and original tables are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The adjunct-to-standard-care comparison is preserved. Matching arm harm collection, observation periods and comparative event results are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Comparative harms, matching collection/follow-up and original tables are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparative harms, matching collection/follow-up and original tables are needed." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Are event counts and exposure denominators available for harm frequencies?", "needed": "Actual exposure, observation/analysis n, attrition, harm counts and observation windows", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Actual exposure, observation/analysis n, attrition, harm counts and observation windows with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Actual exposure, observation/analysis n, attrition, harm counts and observation windows 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: Harm counts, exposure/observation denominators and discontinuation reasons are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "There are 91 randomized, 68 completed and original 23 withdrawals/25.3% attrition. Harm counts, exposure/observation denominators and discontinuation reasons are separately unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Harm counts, exposure/observation denominators and discontinuation reasons are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm counts, exposure/observation denominators and discontinuation reasons are needed." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are medication, lifestyle care and other exposures separated from harm causes?", "needed": "Concurrent medication/lifestyle care, baseline disease, attrition and event sequence", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Concurrent medication/lifestyle care, baseline disease, attrition and event sequence with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Concurrent medication/lifestyle care, baseline disease, attrition and event sequence 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: Concurrent factors, actual events, causality judgments and timing are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original context is an adjunct with medication/lifestyle management continued. Actual harm relationships with other diseases/treatments, causality judgments and timing are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Concurrent factors, actual events, causality judgments and timing are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent factors, actual events, causality judgments and timing are needed." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "How do completion/attrition differ from missing harm reports?", "needed": "Attrition/discontinuation reasons, missing symptoms, selective reporting and follow-up", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Attrition/discontinuation reasons, missing symptoms, selective reporting and follow-up with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Attrition/discontinuation reasons, missing symptoms, selective reporting and follow-up 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: Harm-related discontinuation, missing data, selective reporting and later follow-up are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "High attrition and complete-case analysis appear in original records. Discontinuation because of harm, omitted symptom reports and later follow-up collection are unverified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Harm-related discontinuation, missing data, selective reporting and later follow-up are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-related discontinuation, missing data, selective reporting and later follow-up are needed." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "What is known about independent, vulnerable-population and later harms?", "needed": "Matching combined exposure, independent reports, vulnerable groups and later harms", "role": "Supplementary; required for extending safety conclusions", "role_reason": "This condition connects Matching combined exposure, independent reports, vulnerable groups and later harms with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Matching combined exposure, independent reports, vulnerable groups and later 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: Independent harm, vulnerable-population and later follow-up materials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Stored scope is a short adjunctive SBP trial and an indirect acute HRV report. Independent harms under the same exposure, vulnerable groups and events after 6 weeks are unverified; no new search was done.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Independent harm, vulnerable-population and later follow-up materials are needed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent harm, vulnerable-population and later follow-up materials are needed." }, { "item_id": "N43", "question_type": "Evidence condition", "question": "How do method copies, frozen conditions, application and content review differ?", "needed": "Method copies, applied conditions, originals, versions and creation/application history", "role": "Required", "role_reason": "This condition connects Method copies, applied conditions, originals, versions and creation/application history with selected 6-week SBP, the combined adjunct, final values, adjusted effects, denominators, attrition, directness and harm boundaries.", "application_exception": "Preserve selected C and the note distinguishing final-value differences from unverified adjusted effects/CIs. Distinguish absent subclaim score/status/axes from parent C with 50 points. Existing differences/attrition values do not become new calculations, ITT, personal effects or independent replication. Create no new grades, safety certification or breathing, medication or treatment instructions.", "criterion": "Material for Method copies, applied conditions, originals, versions and creation/application history 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: This does not indicate completed content review or new official-method/clinical certification. This records needed materials; no new research was executed.", "current_reports": [], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserved copies of 5 method HTML files, applied conditions and the review contract are linked. Condition freezing and observation application are separate; creation and existing production-wording correction histories are preserved. Content/claim-boundary review remains incomplete.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "This does not indicate completed content review or new official-method/clinical certification.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This does not indicate completed content review or new official-method/clinical certification." } ], "reports": [ { "report_id": "R01", "title": "Mittal G, et al. An Exploratory Randomised Trial to Assess the Effect of Nadi Shodhan Pranayama as an Adjunct Versus Standard Non-pharmacological Management in Hypertensives. Ann Neurosci. 2025. PMID: 40242728. PMCID: PMC11996816. DOI: 10.1177/09727531251318810.", "url": "https://pubmed.ncbi.nlm.nih.gov/40242728/", "report_type": "Randomized adjunct-to-standard-management trial", "existence": "Report linked in the original parent stored summary evidence/citation lists. External public availability, access and current acquisition of the original are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "study_family": "Original report R01; unique counts and independent replication unverified", "independent_replication": "Mittal SBP, DBP and HRV are measures from one stored report; Ghiya compares acute HRV with another pranayama. Report/cohort relationships and unique-trial/participant totals are unverified. Repeated measures, randomized/completed/withdrawn participants and other questions are not counted as new independent SBP trials or participant totals.", "observed_result": "SBP 139.14±12.5 vs 147.79±12.8, P<.01; DBP P>.05", "result_level": "Complete-case final values from the direct combined 6-week SBP adjunct. Preserve 91 randomized, 68 completed and original 23 withdrawals/25.3% attrition. Crude final-value difference -8.65 mmHg is not adjusted change or ITT; the meaning of ±, exact arm denominators and adjusted effects/95% CIs are unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "Analysis plan and original tables", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "Intervention and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." }, { "material_type": "Support and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 40242728, PMCID PMC11996816 and DOI 10.1177/09727531251318810. The original registration wording is CTRI/2023/11/059625. Do not turn CTRI into NCT or infer a new registration URL, prospective status or original-text reading." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/40242728/" } ] }, { "report_id": "R02", "title": "Ghiya S, et al. Comparison of the effects of Nadi Shodhana Pranayama and Bhramari Pranayama on heart rate variability. J Ayurveda Integr Med. 2023. PMID: 37499590. PMCID: PMC10388195. DOI: 10.1016/j.jaim.2023.100774.", "url": "https://pubmed.ncbi.nlm.nih.gov/37499590/", "report_type": "Acute comparison with another pranayama", "existence": "Report linked in the original parent stored summary evidence/citation lists. External public availability, access and current acquisition of the original are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "study_family": "Original report R02; unique counts and independent replication unverified", "independent_replication": "Mittal SBP, DBP and HRV are measures from one stored report; Ghiya compares acute HRV with another pranayama. Report/cohort relationships and unique-trial/participant totals are unverified. Repeated measures, randomized/completed/withdrawn participants and other questions are not counted as new independent SBP trials or participant totals.", "observed_result": "Between-group HRV was null", "result_level": "Separate 100-participant acute HRV comparison with another pranayama; preserve the original between-group null result. This is not independent 6-week SBP replication; population, arm denominators, measure-specific effects/CIs and report-family relationships are unverified.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "Analysis plan and original tables", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "Intervention and harms", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." }, { "material_type": "Support and interests", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Preserve original PubMed URL, PMID 37499590, PMCID PMC10388195 and DOI 10.1016/j.jaim.2023.100774. The original evidence registration field says unverified. This does not establish no registration; no new identifier, URL, prospective status or original-text reading is inferred." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37499590/" } ] } ], "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Awaiting user review, or actual review remains incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Mittal SBP, DBP and HRV are measures from one stored report; Ghiya compares acute HRV with another pranayama. Report/cohort relationships and unique-trial/participant totals are unverified. Repeated measures, randomized/completed/withdrawn participants and other questions are not counted as new independent SBP trials or participant totals." }, "history": [ { "date": "2026-10-18", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 43 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-18" }