High-resistance IMST × diastolic pressure and cardiovascular events: evidence gaps

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich diastolic-pressure and cardiovascular-event claim is examined?Required	The selected subclaim's original grade is D; its note records a null DBP interaction and unmeasured events. Subclaim score, status and axes are absent and distinguished from parent SBP C54, Caution and axes. R01	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.	Selected DBP and cardiovascular-event benefit claim	Material needed: Materials identifying the direct DBP result and unmeasured cardiovascular events separately, plus content review, are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat is the direct resting diastolic-pressure test?Required	The original records diastolic-pressure interaction P=.17. Exact DBP arm values, adjusted between-group estimates and CIs are unverified. A null finding is not converted into zero effect, equivalence or failure of every program. R01	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.	Resting DBP interaction and separate between-group effects	Material needed: DBP measurement conditions, denominators, original values, models, between-group effects, 95% CIs, contrasts of interest and prespecified hierarchy are needed. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionDoes positive resting SBP establish a DBP effect?Required	Resting SBP 135±2 to 126±3 versus 134±2 to 131±3 mmHg, P=.02, is a separate endpoint. The 9 mmHg within-arm fall and 6 mmHg crude difference also concern SBP and are not transferred to DBP/event numbers. R01	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.	Parent SBP versus selected DBP/event endpoints	Material needed: DBP-specific original tables, denominators, effects, CIs and measurement conditions are needed. Original SBP numbers are not copied to other endpoints or used for new difference calculations. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre resting, ambulatory and 24-hour DBP distinguished?Required	The original distinguishes ambulatory SBP P=.07 from DBP P=.17 and records P=.17 as the diastolic interaction. Exact ambulatory/24-hour DBP values and daytime/nighttime effects are not separately established. R01	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.	Measurement conditions and SBP/DBP endpoints	Material needed: Resting/ambulatory DBP tables, measurement coverage, valid time, day/night definitions, denominators, models, effects and CIs are needed. Ambulatory SBP P=.07 is not changed into an ambulatory DBP P value. This records needed materials; no new research was executed.
5	Unverified	Full text not readStored summary read	N05 · Evidence conditionWere cardiovascular events directly tested or measured?Required	The original records that cardiovascular-event prevention was not tested; the subclaim note records unmeasured events. Event types, arm-specific counts, risk time, effects and CIs are unverified. Nonmeasurement does not become zero events or zero prevention effect. R01	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.	Direct clinical events versus nonmeasurement	Material needed: Direct event definitions/adjudication, arm-specific events/risk time, follow-up, missingness and original effects/CIs are needed. No new event analysis or retrieval was executed. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre null DBP and unmeasured events the same state?Required	DBP has test P=.17 while events were not measured, as originally stated. The single original subclaim grade D is retained, but the two endpoints are not combined into the same zero-effect/null conclusion. R01	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.	Tested DBP versus unmeasured-event evidence states	Material needed: DBP effects/CIs and direct clinical-event material are needed separately. They are distinguished within the existing question without creating new subclaims or revising grades. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionDoes relative FMD improvement establish event prevention?Required	Original approximately 45% FMD is a relative change, not a 45-percentage-point increase. The original describes a separate surrogate. Bibliographic mentions of NO/oxidative stress are not converted into direct clinical-event results. R01	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.	FMD, mechanisms and clinical events	Material needed: Original FMD/mechanism tables, denominators, CIs and direct event definitions, follow-up and risk data are needed. No new mechanism numbers, risk conversions or hypothetical examples are created. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionIs six-week exposure the same as long-term event follow-up?Required	The original 36-person analysis and six-week training concern blood-pressure surrogates. Duration, denominators and CIs for long-term events, medication replacement or post-training persistence follow-up are not established in the stored summary. R01	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.	Short-term pressure results versus long-term events/follow-up	Material needed: Direct long-term studies, risk time, follow-up loss, maintained exposure, actual denominators and event effects/CIs are needed. Original duration is not transferred to long-term incidence. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionDo population and baseline medication fit the event question?Required	The original population is adults aged 50–79 with above-normal pressure. Confirmed hypertension-treatment status, cardiovascular disease, baseline risk, medication and other eligibility details are unverified. Effects are not established for all cardiovascular patients or people changing medication. R01	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.	Ages 50–79 and above-normal blood-pressure eligibility	Material needed: Original DBP/event eligibility, baseline medication/disease, baseline DBP/risk, arm values and denominators are needed. No breathing-method, device or medication-change instructions are created. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre original counts valid DBP/event denominators?Required	Original 38 randomized, 36 analyzed and 18 per arm describe pressure-trial flow. Valid DBP denominators, event risk time/denominators and analysis-exclusion reasons are separately unverified. These counts are not copied as verified denominators for every endpoint. R01	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.	Allocation/analysis flow versus endpoint denominators and risk time	Material needed: Original analysis flow, endpoint-specific allocation, valid values, missingness, event risk time and follow-up are needed. No new dropout counts/rates or participant sums are created. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre exact DBP/event effects and CIs available?Required	DBP P=.17 is not an exact between-group magnitude or CI. Events were not directly measured, so estimates/CIs cannot be created. SBP ± values or its adjusted-CI gap are not changed into DBP/event results. R01	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.	P values versus endpoint-specific effect sizes and precision	Material needed: Original endpoint values, models, denominators, adjusted effects, CIs, clinical importance and direct event material are needed. No hypothetical quantification or new calculations are made. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs low-resistance sham a medication-replacement control?Required	The original control is 15% low-resistance sham; parent material cautions against extending it to medication replacement or vascular-event prevention. This pressure trial is not read as a direct test of medication equivalence or replacement of medication/standard care. R01	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.	15% low-resistance sham versus direct medication comparisons	Material needed: Direct medication/standard-care comparisons, prior margins, analysis populations, clinical endpoints, CIs and concurrent care are needed. No treatment-replacement, dose-reduction, device-setting or procedure instructions are created. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionDoes preregistration wording verify an event endpoint?Required	The original records a preregistered trial/NCT03266510 and historical SBP, DBP, ambulatory-pressure and FMD checks. Registration remains unread here; events are not certified as a prior endpoint, and nonmeasurement is retained. R01	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.	NCT03266510, historical checks and nonmeasurement	Material needed: Registration/protocol/SAP endpoints, times, change history, DBP hierarchy/analysis plans and event design are needed. Comparison with actual prior plans remains incomplete. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionDo harm statements establish prevention or incidence?Supplementary	Original possible neck discomfort/dizziness and boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing caution statements. They are not newly established as observed counts, incidence, arm-specific harm denominators, CIs or cardiovascular-prevention effects. R01	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.	Original caution statements versus actual clinical-event data	Material needed: Original harm definitions, collection, exposure, denominators, withdrawal, comparator, severity and long-term clinical-event material are needed. No new incidence, training or treatment instructions are created. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat direct material would fill DBP/event gaps?Required	The current preserved state is a null DBP interaction and unmeasured events. Short-term SBP/FMD do not fill these gaps; direct DBP effects/CIs and sufficient event follow-up are needed separately. R01	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.	Direct DBP results and sufficient clinical-event follow-up	Material needed: Original DBP tables, clinical-event definitions, follow-up, denominators, effects, CIs, actual exposure and concurrent care for the same population/intervention/comparator are needed. Needed material is recorded without new research, calculation or regrading. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre the same report, trial and participants counted twice?Required	Parent 2990 and two subclaim sheets share the same Craighead 2021 bibliography/trial context. Sheets, reports, pressure/FMD endpoints and follow-up measurements do not create new independent trials/participants, and 38 randomized/36 analyzed are not added as separate people. Unique-trial and participant totals are unverified. R01	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.	Shared parent/subclaim sheets and Craighead report	Material needed: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhich materials were actually read?Required	The complete stored parent-verdict summary was read. External abstracts, full text, registration, protocols and SAPs remain unread. URL, PMCID or NCT presence does not establish actual reading, access or condition fulfillment. R01	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.	Distinguishing the stored summary from external originals	Material needed: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhere are bibliography and registration identifiers recorded?Required	The citation list contains PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and the original PubMed URL. NCT03266510 is in the evidence item; the citation text itself contains no registration statement. R01	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.	PMID, PMCID, DOI and the evidence-item NCT	Material needed: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre historical bilingual checks the current review?Required	Original Korean/English wording and historical statements about checking pressure, FMD, denominators and funding in reports, the primary trial and registration are preserved. Historical verification does not establish current external reading or completed clinical review. R01	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.	Original bilingual wording and historical verification scope	Material needed: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre subclaim values separated from parent scores and axes?Required	Original selected grade D/note and absent subclaim score, status and axes are preserved. Parent C54, Caution, B/S/R1/I2/E+/B2 and unrecorded precision remain parent context; they do not fill subclaim scores, axes or independence certification. R01	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.	Original subclaim grade/note and absent score, status and axes	Material needed: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre the evidence date and production date distinguished?Required	Original evidence date 2026-09-07, empty corrections array and empty deliberation string are retained. This is not the current production/review date or certification that no external corrections exist. R01	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.	Original evidence date, correction and deliberation records	Material needed: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre public funding and company-related dimensions separated?Required	Original funding records public/nonprofit support including NIH and the American Heart Association. This does not separately verify device/product support, company-employee authors or company involvement in analysis/reporting. R01	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.	Funding, product support, employee authors and analysis/reporting roles	Material needed: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification. This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionAre randomization, masking, measurement and selective reporting detailed?Required	The original design is randomized with low-resistance sham control. Allocation concealment, participant/assessor masking, pressure/FMD measurements, missingness and selective-reporting details are separately unverified. R01	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.	Sham-controlled design, bias and prior plans	Material needed: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre actual exposure, adherence and concurrent care verified?Required	Original exposure and directional adherence statements remain study-identification context. Actual breathing/resistance exposure, intervention deviations, baseline/follow-up medication, diet/activity changes and detailed denominators are unverified. R01	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.	Study identification versus actual exposure and cointerventions	Material needed: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre possible harms separated from observed event counts?Supplementary	The original describes possible neck discomfort/dizziness and boundaries for certain cardiopulmonary conditions/symptoms. Possibilities do not all establish observed events; counts, incidence, collection methods, exposure denominators and CIs are unverified. R01	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.	Original caution statements and actual harm collection/denominators	Material needed: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre long-term, rare harms and applicability verified?Supplementary	A six-week completer pressure study is not extended to rare-harm rates, long-term events or safety of medication replacement. Original boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing statements, not new treatment decisions or procedures. R01	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.	Six-week selected adults versus long-term harms	Material needed: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events. This records needed materials; no new research was executed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhich materials would trigger an update?Required	This sheet organizes stored material concerning DBP and cardiovascular events. Related observations can be updated after content review of original reports, between-group effects, denominators, prior plans, endpoints, times, follow-up, support and harm data. R01	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.	Separating originals, applied conditions, observations and verdict changes	Material needed: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished. This records needed materials; no new research was executed.

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27 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Middle-aged and older adults aged 50–79 with above-normal pressure. The original records 38 randomized, 36 analyzed and 18 analyzed per arm. Exact eligibility, baseline medication, disease, valid DBP denominators, clinical-event risk time/denominators and missingness are unverified. Allocation/analysis are not added as separate people or filled as verified denominators for every endpoint.
Ingredient, formulation and route: High-resistance inspiratory muscle strength training (IMST) in the original study. This identifies preserved exposure without personal procedures, device settings, treatment decisions or medication-replacement advice. Actual exposure, adherence and concurrent-care details are unverified.
Dose: Original six days weekly, 30 breaths daily, six weeks, 55% maximal inspiratory pressure in week 1, 65% in week 2, 75% thereafter and five sets of six breaths are preserved only to identify the study. No new total-exposure, frequency or individual-resistance calculations or training instructions are created.
Comparator: Low-resistance 15% sham. This is not no intervention, no breathing training or a direct medication comparison. Actual control exposure, masking, sensations/attention, concurrent care and direct-contrast details are unverified.
Measured outcome: The selected question concerns diastolic-pressure/cardiovascular-event benefit and original subclaim grade is D. Null DBP interaction P=.17 and unmeasured cardiovascular events are distinguished. Exact DBP values, adjusted between-group effects, 95% CIs, event counts, risk time and risk effects are unverified. Parent resting SBP P=.02, ambulatory SBP P=.07 and approximately 45% relative FMD change are separate results, not transferred into DBP/clinical-event values.
Duration: Short-term results after six weeks of training/pressure measurement. Post-training DBP persistence, actual long-term follow-up, cardiovascular events, rare harms and medication-replacement effects are unverified. Original duration is not converted into long-term event risk time, incidence or safety, and follow-up values are not newly filled.
Questions outside this scope: Converting null DBP P=.17 and unmeasured cardiovascular events into the same zero effect, equivalence or zero events; Transferring parent SBP values, within-arm 9 mmHg, crude difference 6 mmHg, P=.02 or ambulatory SBP P=.07 into adjusted DBP/event effects or CIs; Converting approximately 45% relative FMD change, NO or oxidative-stress bibliography into percentage points or direct cardiovascular-event-prevention effects; Adding 38 randomized, 36 analyzed, 18 per arm, multiple endpoints or two subclaim sheets as new independent trials, participants or event denominators; Inheriting parent C54, Caution, axes or historical checks as grade-D subclaim scores, current clinical review or independence certification; Creating new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training, medication changes or treatment-replacement instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Craighead DH, Heinbockel TC, Freeberg KA, et al. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021;10:e020980. PMID: 34184544. PMCID: PMC8403283. DOI: 10.1161/JAHA.121.020980.

PubMed

Material type: Low-resistance sham-controlled randomized trial
Materials actually read: Stored summary read; external paper, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: SBP 135±2 to 126±3 versus 134±2 to 131±3 mmHg; group-by-time P=.02
Record level: The original report summary of SBP 135±2 to 126±3 versus 134±2 to 131±3 mmHg, P=.02, is preserved as parent context. Selected original subclaim grade D, null DBP P=.17 and unmeasured cardiovascular events are distinguished. Exact DBP between-group effects/CIs/denominators and event counts, risk time and risk effects are unverified. SBP, ambulatory pressure, FMD, mechanisms and caution statements are not converted into direct DBP/event-prevention results or harm incidence.
Study overlap and independent replication: The single Craighead 2021 report, parent 2990 and two subclaim sheets share the same trial/population context. The 38 randomized, 36 analyzed, 18 per arm, pressure/FMD endpoints and follow-up measurements are not added as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Preserved copy of the complete parent-verdict stored summary	Existing stored review summary read	Summary read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
fulltext	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
registration	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.
protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and evidence-item NCT03266510 are preserved. The citation text itself has no registration statement. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred.

Report counts versus independent study counts

The single Craighead 2021 report, parent 2990 and two subclaim sheets share the same trial/population context. The 38 randomized, 36 analyzed, 18 per arm, pressure/FMD endpoints and follow-up measurements are not added as new independent trials, participants or replications. Confirmed unique-trial, participant and independent-replication totals remain unrecorded.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which diastolic-pressure and cardiovascular-event claim is examined?

Required materials and conditions: Selected DBP and cardiovascular-event benefit claim
Conditions for verification: Material for Selected DBP and cardiovascular-event benefit claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Selected DBP and cardiovascular-event benefit claim with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · What is the direct resting diastolic-pressure test?

Required materials and conditions: Resting DBP interaction and separate between-group effects
Conditions for verification: Material for Resting DBP interaction and separate between-group effects must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Resting DBP interaction and separate between-group effects with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Does positive resting SBP establish a DBP effect?

Required materials and conditions: Parent SBP versus selected DBP/event endpoints
Conditions for verification: Material for Parent SBP versus selected DBP/event endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Parent SBP versus selected DBP/event endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · Are resting, ambulatory and 24-hour DBP distinguished?

Required materials and conditions: Measurement conditions and SBP/DBP endpoints
Conditions for verification: Material for Measurement conditions and SBP/DBP endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Measurement conditions and SBP/DBP endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · Were cardiovascular events directly tested or measured?

Required materials and conditions: Direct clinical events versus nonmeasurement
Conditions for verification: Material for Direct clinical events versus nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Direct clinical events versus nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Are null DBP and unmeasured events the same state?

Required materials and conditions: Tested DBP versus unmeasured-event evidence states
Conditions for verification: Material for Tested DBP versus unmeasured-event evidence states must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Tested DBP versus unmeasured-event evidence states with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · Does relative FMD improvement establish event prevention?

Required materials and conditions: FMD, mechanisms and clinical events
Conditions for verification: Material for FMD, mechanisms and clinical events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects FMD, mechanisms and clinical events with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · Is six-week exposure the same as long-term event follow-up?

Required materials and conditions: Short-term pressure results versus long-term events/follow-up
Conditions for verification: Material for Short-term pressure results versus long-term events/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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Short-term pressure results versus long-term events/follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · Do population and baseline medication fit the event question?

Required materials and conditions: Ages 50–79 and above-normal blood-pressure eligibility
Conditions for verification: Material for Ages 50–79 and above-normal blood-pressure eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · Are original counts valid DBP/event denominators?

Required materials and conditions: Allocation/analysis flow versus endpoint denominators and risk time
Conditions for verification: Material for Allocation/analysis flow versus endpoint denominators and risk time must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Allocation/analysis flow versus endpoint denominators and risk time with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · Are exact DBP/event effects and CIs available?

Required materials and conditions: P values versus endpoint-specific effect sizes and precision
Conditions for verification: Material for P values versus endpoint-specific effect sizes and precision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects P values versus endpoint-specific effect sizes and precision with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Is low-resistance sham a medication-replacement control?

Required materials and conditions: 15% low-resistance sham versus direct medication comparisons
Conditions for verification: Material for 15% low-resistance sham versus direct medication comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects 15% low-resistance sham versus direct medication comparisons with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · Does preregistration wording verify an event endpoint?

Required materials and conditions: NCT03266510, historical checks and nonmeasurement
Conditions for verification: Material for NCT03266510, historical checks and nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects NCT03266510, historical checks and nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · Do harm statements establish prevention or incidence?

Required materials and conditions: Original caution statements versus actual clinical-event data
Conditions for verification: Material for Original caution statements versus actual clinical-event data must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original caution statements versus actual clinical-event data with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · What direct material would fill DBP/event gaps?

Required materials and conditions: Direct DBP results and sufficient clinical-event follow-up
Conditions for verification: Material for Direct DBP results and sufficient clinical-event 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.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Direct DBP results and sufficient clinical-event follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · Are the same report, trial and participants counted twice?

Required materials and conditions: Shared parent/subclaim sheets and Craighead report
Conditions for verification: Material for Shared parent/subclaim sheets and Craighead report must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Shared parent/subclaim sheets and Craighead report with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Which materials were actually read?

Required materials and conditions: Distinguishing the stored summary from external originals
Conditions for verification: Material for Distinguishing the stored summary from external originals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Distinguishing the stored summary from external originals with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Where are bibliography and registration identifiers recorded?

Required materials and conditions: PMID, PMCID, DOI and the evidence-item NCT
Conditions for verification: Material for PMID, PMCID, DOI and the evidence-item NCT must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · Are historical bilingual checks the current review?

Required materials and conditions: Original bilingual wording and historical verification scope
Conditions for verification: Material for Original bilingual wording and historical verification scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original bilingual wording and historical verification scope with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · Are subclaim values separated from parent scores and axes?

Required materials and conditions: Original subclaim grade/note and absent score, status and axes
Conditions for verification: Material for Original subclaim grade/note and absent score, status and axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score, status and axes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · Are the evidence date and production date distinguished?

Required materials and conditions: Original evidence date, correction and deliberation records
Conditions for verification: Material for Original evidence date, correction and deliberation records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original evidence date, correction and deliberation records with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Are public funding and company-related dimensions separated?

Required materials and conditions: Funding, product support, employee authors and analysis/reporting roles
Conditions for verification: Material for Funding, product support, employee authors and analysis/reporting roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Are randomization, masking, measurement and selective reporting detailed?

Required materials and conditions: Sham-controlled design, bias and prior plans
Conditions for verification: Material for Sham-controlled design, bias and prior plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Sham-controlled design, bias and prior plans with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N24 · Are actual exposure, adherence and concurrent care verified?

Required materials and conditions: Study identification versus actual exposure and cointerventions
Conditions for verification: Material for Study identification versus actual exposure and cointerventions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Study identification versus actual exposure and cointerventions with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · Are possible harms separated from observed event counts?

Required materials and conditions: Original caution statements and actual harm collection/denominators
Conditions for verification: Material for Original caution statements and actual harm collection/denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Original caution statements and actual harm collection/denominators with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Are long-term, rare harms and applicability verified?

Required materials and conditions: Six-week selected adults versus long-term harms
Conditions for verification: Material for Six-week selected adults versus long-term harms must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Six-week selected adults versus long-term harms with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N27 · Which materials would trigger an update?

Required materials and conditions: Separating originals, applied conditions, observations and verdict changes
Conditions for verification: Material for Separating originals, applied conditions, observations and verdict changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Why this condition is needed: This condition connects Separating originals, applied conditions, observations and verdict changes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

What the statuses mean

Partly verified: Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Awaiting user review
Met: Use only within the relevant condition's scope after user review; no automatic display in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-16 · Public page/material version 1.0

Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which diastolic-pressure and cardiovascular-event claim is examined?

Current findings: The selected subclaim's original grade is D; its note records a null DBP interaction and unmeasured events. Subclaim score, status and axes are absent and distinguished from parent SBP C54, Caution and axes.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Materials identifying the direct DBP result and unmeasured cardiovascular events separately, plus content review, are needed. Absent subclaim fields are not filled with parent scores or axes.
Required materials and conditions: Selected DBP and cardiovascular-event benefit claim
Materials to obtain first: Materials identifying the direct DBP result and unmeasured cardiovascular events separately, plus content review, are needed. Absent subclaim fields are not filled with parent scores or axes.
Further research: Material needed: Materials identifying the direct DBP result and unmeasured cardiovascular events separately, plus content review, are needed. Absent subclaim fields are not filled with parent scores or axes. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Selected DBP and cardiovascular-event benefit claim must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Selected DBP and cardiovascular-event benefit claim with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N02 · What is the direct resting diastolic-pressure test?

Current findings: The original records diastolic-pressure interaction P=.17. Exact DBP arm values, adjusted between-group estimates and CIs are unverified. A null finding is not converted into zero effect, equivalence or failure of every program.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: DBP measurement conditions, denominators, original values, models, between-group effects, 95% CIs, contrasts of interest and prespecified hierarchy are needed.
Required materials and conditions: Resting DBP interaction and separate between-group effects
Materials to obtain first: DBP measurement conditions, denominators, original values, models, between-group effects, 95% CIs, contrasts of interest and prespecified hierarchy are needed.
Further research: Material needed: DBP measurement conditions, denominators, original values, models, between-group effects, 95% CIs, contrasts of interest and prespecified hierarchy are needed. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Resting DBP interaction and separate between-group effects must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Resting DBP interaction and separate between-group effects with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N03 · Does positive resting SBP establish a DBP effect?

Current findings: Resting SBP 135±2 to 126±3 versus 134±2 to 131±3 mmHg, P=.02, is a separate endpoint. The 9 mmHg within-arm fall and 6 mmHg crude difference also concern SBP and are not transferred to DBP/event numbers.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: DBP-specific original tables, denominators, effects, CIs and measurement conditions are needed. Original SBP numbers are not copied to other endpoints or used for new difference calculations.
Required materials and conditions: Parent SBP versus selected DBP/event endpoints
Materials to obtain first: DBP-specific original tables, denominators, effects, CIs and measurement conditions are needed. Original SBP numbers are not copied to other endpoints or used for new difference calculations.
Further research: Material needed: DBP-specific original tables, denominators, effects, CIs and measurement conditions are needed. Original SBP numbers are not copied to other endpoints or used for new difference calculations. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Parent SBP versus selected DBP/event endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Parent SBP versus selected DBP/event endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N04 · Are resting, ambulatory and 24-hour DBP distinguished?

Current findings: The original distinguishes ambulatory SBP P=.07 from DBP P=.17 and records P=.17 as the diastolic interaction. Exact ambulatory/24-hour DBP values and daytime/nighttime effects are not separately established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Resting/ambulatory DBP tables, measurement coverage, valid time, day/night definitions, denominators, models, effects and CIs are needed. Ambulatory SBP P=.07 is not changed into an ambulatory DBP P value.
Required materials and conditions: Measurement conditions and SBP/DBP endpoints
Materials to obtain first: Resting/ambulatory DBP tables, measurement coverage, valid time, day/night definitions, denominators, models, effects and CIs are needed. Ambulatory SBP P=.07 is not changed into an ambulatory DBP P value.
Further research: Material needed: Resting/ambulatory DBP tables, measurement coverage, valid time, day/night definitions, denominators, models, effects and CIs are needed. Ambulatory SBP P=.07 is not changed into an ambulatory DBP P value. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Measurement conditions and SBP/DBP endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Measurement conditions and SBP/DBP endpoints with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N05 · Were cardiovascular events directly tested or measured?

Current findings: The original records that cardiovascular-event prevention was not tested; the subclaim note records unmeasured events. Event types, arm-specific counts, risk time, effects and CIs are unverified. Nonmeasurement does not become zero events or zero prevention effect.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Direct event definitions/adjudication, arm-specific events/risk time, follow-up, missingness and original effects/CIs are needed. No new event analysis or retrieval was executed.
Required materials and conditions: Direct clinical events versus nonmeasurement
Materials to obtain first: Direct event definitions/adjudication, arm-specific events/risk time, follow-up, missingness and original effects/CIs are needed. No new event analysis or retrieval was executed.
Further research: Material needed: Direct event definitions/adjudication, arm-specific events/risk time, follow-up, missingness and original effects/CIs are needed. No new event analysis or retrieval was executed. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Direct clinical events versus nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Direct clinical events versus nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N06 · Are null DBP and unmeasured events the same state?

Current findings: DBP has test P=.17 while events were not measured, as originally stated. The single original subclaim grade D is retained, but the two endpoints are not combined into the same zero-effect/null conclusion.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: DBP effects/CIs and direct clinical-event material are needed separately. They are distinguished within the existing question without creating new subclaims or revising grades.
Required materials and conditions: Tested DBP versus unmeasured-event evidence states
Materials to obtain first: DBP effects/CIs and direct clinical-event material are needed separately. They are distinguished within the existing question without creating new subclaims or revising grades.
Further research: Material needed: DBP effects/CIs and direct clinical-event material are needed separately. They are distinguished within the existing question without creating new subclaims or revising grades. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Tested DBP versus unmeasured-event evidence states must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Tested DBP versus unmeasured-event evidence states with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N07 · Does relative FMD improvement establish event prevention?

Current findings: Original approximately 45% FMD is a relative change, not a 45-percentage-point increase. The original describes a separate surrogate. Bibliographic mentions of NO/oxidative stress are not converted into direct clinical-event results.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original FMD/mechanism tables, denominators, CIs and direct event definitions, follow-up and risk data are needed. No new mechanism numbers, risk conversions or hypothetical examples are created.
Required materials and conditions: FMD, mechanisms and clinical events
Materials to obtain first: Original FMD/mechanism tables, denominators, CIs and direct event definitions, follow-up and risk data are needed. No new mechanism numbers, risk conversions or hypothetical examples are created.
Further research: Material needed: Original FMD/mechanism tables, denominators, CIs and direct event definitions, follow-up and risk data are needed. No new mechanism numbers, risk conversions or hypothetical examples are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for FMD, mechanisms and clinical events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects FMD, mechanisms and clinical events with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N08 · Is six-week exposure the same as long-term event follow-up?

Current findings: The original 36-person analysis and six-week training concern blood-pressure surrogates. Duration, denominators and CIs for long-term events, medication replacement or post-training persistence follow-up are not established in the stored summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Direct long-term studies, risk time, follow-up loss, maintained exposure, actual denominators and event effects/CIs are needed. Original duration is not transferred to long-term incidence.
Required materials and conditions: Short-term pressure results versus long-term events/follow-up
Materials to obtain first: Direct long-term studies, risk time, follow-up loss, maintained exposure, actual denominators and event effects/CIs are needed. Original duration is not transferred to long-term incidence.
Further research: Material needed: Direct long-term studies, risk time, follow-up loss, maintained exposure, actual denominators and event effects/CIs are needed. Original duration is not transferred to long-term incidence. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Short-term pressure results versus long-term events/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.
Why this condition is needed: This condition connects Short-term pressure results versus long-term events/follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N09 · Do population and baseline medication fit the event question?

Current findings: The original population is adults aged 50–79 with above-normal pressure. Confirmed hypertension-treatment status, cardiovascular disease, baseline risk, medication and other eligibility details are unverified. Effects are not established for all cardiovascular patients or people changing medication.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original DBP/event eligibility, baseline medication/disease, baseline DBP/risk, arm values and denominators are needed. No breathing-method, device or medication-change instructions are created.
Required materials and conditions: Ages 50–79 and above-normal blood-pressure eligibility
Materials to obtain first: Original DBP/event eligibility, baseline medication/disease, baseline DBP/risk, arm values and denominators are needed. No breathing-method, device or medication-change instructions are created.
Further research: Material needed: Original DBP/event eligibility, baseline medication/disease, baseline DBP/risk, arm values and denominators are needed. No breathing-method, device or medication-change instructions are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Ages 50–79 and above-normal blood-pressure eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Ages 50–79 and above-normal blood-pressure eligibility with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N10 · Are original counts valid DBP/event denominators?

Current findings: Original 38 randomized, 36 analyzed and 18 per arm describe pressure-trial flow. Valid DBP denominators, event risk time/denominators and analysis-exclusion reasons are separately unverified. These counts are not copied as verified denominators for every endpoint.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original analysis flow, endpoint-specific allocation, valid values, missingness, event risk time and follow-up are needed. No new dropout counts/rates or participant sums are created.
Required materials and conditions: Allocation/analysis flow versus endpoint denominators and risk time
Materials to obtain first: Original analysis flow, endpoint-specific allocation, valid values, missingness, event risk time and follow-up are needed. No new dropout counts/rates or participant sums are created.
Further research: Material needed: Original analysis flow, endpoint-specific allocation, valid values, missingness, event risk time and follow-up are needed. No new dropout counts/rates or participant sums are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Allocation/analysis flow versus endpoint denominators and risk time must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Allocation/analysis flow versus endpoint denominators and risk time with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N11 · Are exact DBP/event effects and CIs available?

Current findings: DBP P=.17 is not an exact between-group magnitude or CI. Events were not directly measured, so estimates/CIs cannot be created. SBP ± values or its adjusted-CI gap are not changed into DBP/event results.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original endpoint values, models, denominators, adjusted effects, CIs, clinical importance and direct event material are needed. No hypothetical quantification or new calculations are made.
Required materials and conditions: P values versus endpoint-specific effect sizes and precision
Materials to obtain first: Original endpoint values, models, denominators, adjusted effects, CIs, clinical importance and direct event material are needed. No hypothetical quantification or new calculations are made.
Further research: Material needed: Original endpoint values, models, denominators, adjusted effects, CIs, clinical importance and direct event material are needed. No hypothetical quantification or new calculations are made. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for P values versus endpoint-specific effect sizes and precision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects P values versus endpoint-specific effect sizes and precision with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N12 · Is low-resistance sham a medication-replacement control?

Current findings: The original control is 15% low-resistance sham; parent material cautions against extending it to medication replacement or vascular-event prevention. This pressure trial is not read as a direct test of medication equivalence or replacement of medication/standard care.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Direct medication/standard-care comparisons, prior margins, analysis populations, clinical endpoints, CIs and concurrent care are needed. No treatment-replacement, dose-reduction, device-setting or procedure instructions are created.
Required materials and conditions: 15% low-resistance sham versus direct medication comparisons
Materials to obtain first: Direct medication/standard-care comparisons, prior margins, analysis populations, clinical endpoints, CIs and concurrent care are needed. No treatment-replacement, dose-reduction, device-setting or procedure instructions are created.
Further research: Material needed: Direct medication/standard-care comparisons, prior margins, analysis populations, clinical endpoints, CIs and concurrent care are needed. No treatment-replacement, dose-reduction, device-setting or procedure instructions are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for 15% low-resistance sham versus direct medication comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 15% low-resistance sham versus direct medication comparisons with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N13 · Does preregistration wording verify an event endpoint?

Current findings: The original records a preregistered trial/NCT03266510 and historical SBP, DBP, ambulatory-pressure and FMD checks. Registration remains unread here; events are not certified as a prior endpoint, and nonmeasurement is retained.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Registration/protocol/SAP endpoints, times, change history, DBP hierarchy/analysis plans and event design are needed. Comparison with actual prior plans remains incomplete.
Required materials and conditions: NCT03266510, historical checks and nonmeasurement
Materials to obtain first: Registration/protocol/SAP endpoints, times, change history, DBP hierarchy/analysis plans and event design are needed. Comparison with actual prior plans remains incomplete.
Further research: Material needed: Registration/protocol/SAP endpoints, times, change history, DBP hierarchy/analysis plans and event design are needed. Comparison with actual prior plans remains incomplete. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for NCT03266510, historical checks and nonmeasurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects NCT03266510, historical checks and nonmeasurement with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N14 · Do harm statements establish prevention or incidence?

Current findings: Original possible neck discomfort/dizziness and boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing caution statements. They are not newly established as observed counts, incidence, arm-specific harm denominators, CIs or cardiovascular-prevention effects.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original harm definitions, collection, exposure, denominators, withdrawal, comparator, severity and long-term clinical-event material are needed. No new incidence, training or treatment instructions are created.
Required materials and conditions: Original caution statements versus actual clinical-event data
Materials to obtain first: Original harm definitions, collection, exposure, denominators, withdrawal, comparator, severity and long-term clinical-event material are needed. No new incidence, training or treatment instructions are created.
Further research: Material needed: Original harm definitions, collection, exposure, denominators, withdrawal, comparator, severity and long-term clinical-event material are needed. No new incidence, training or treatment instructions are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Original caution statements versus actual clinical-event data must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original caution statements versus actual clinical-event data with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N15 · What direct material would fill DBP/event gaps?

Current findings: The current preserved state is a null DBP interaction and unmeasured events. Short-term SBP/FMD do not fill these gaps; direct DBP effects/CIs and sufficient event follow-up are needed separately.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original DBP tables, clinical-event definitions, follow-up, denominators, effects, CIs, actual exposure and concurrent care for the same population/intervention/comparator are needed. Needed material is recorded without new research, calculation or regrading.
Required materials and conditions: Direct DBP results and sufficient clinical-event follow-up
Materials to obtain first: Original DBP tables, clinical-event definitions, follow-up, denominators, effects, CIs, actual exposure and concurrent care for the same population/intervention/comparator are needed. Needed material is recorded without new research, calculation or regrading.
Further research: Material needed: Original DBP tables, clinical-event definitions, follow-up, denominators, effects, CIs, actual exposure and concurrent care for the same population/intervention/comparator are needed. Needed material is recorded without new research, calculation or regrading. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Direct DBP results and sufficient clinical-event 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.
Why this condition is needed: This condition connects Direct DBP results and sufficient clinical-event follow-up with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N16 · Are the same report, trial and participants counted twice?

Current findings: Parent 2990 and two subclaim sheets share the same Craighead 2021 bibliography/trial context. Sheets, reports, pressure/FMD endpoints and follow-up measurements do not create new independent trials/participants, and 38 randomized/36 analyzed are not added as separate people. Unique-trial and participant totals are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts.
Required materials and conditions: Shared parent/subclaim sheets and Craighead report
Materials to obtain first: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts.
Further research: Material needed: Links between original reports, cohorts, analysis populations, endpoints and follow-up measurements are needed. Report/material counts are not quality scores or unique-trial counts. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Shared parent/subclaim sheets and Craighead report must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Shared parent/subclaim sheets and Craighead report with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N17 · Which materials were actually read?

Current findings: The complete stored parent-verdict summary was read. External abstracts, full text, registration, protocols and SAPs remain unread. URL, PMCID or NCT presence does not establish actual reading, access or condition fulfillment.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here.
Required materials and conditions: Distinguishing the stored summary from external originals
Materials to obtain first: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here.
Further research: Material needed: Actual acquisition/reading records for originals, appendices, registration and plans are needed. No external material was newly retrieved or read here. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Distinguishing the stored summary from external originals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Distinguishing the stored summary from external originals with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N18 · Where are bibliography and registration identifiers recorded?

Current findings: The citation list contains PMID 34184544, PMCID PMC8403283, DOI 10.1161/JAHA.121.020980 and the original PubMed URL. NCT03266510 is in the evidence item; the citation text itself contains no registration statement.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved.
Required materials and conditions: PMID, PMCID, DOI and the evidence-item NCT
Materials to obtain first: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved.
Further research: Material needed: Original paper-registration links, dates and content are needed. New URLs are not inferred from PMCID/NCT; original identifiers are preserved. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for PMID, PMCID, DOI and the evidence-item NCT must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects PMID, PMCID, DOI and the evidence-item NCT with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N19 · Are historical bilingual checks the current review?

Current findings: Original Korean/English wording and historical statements about checking pressure, FMD, denominators and funding in reports, the primary trial and registration are preserved. Historical verification does not establish current external reading or completed clinical review.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation.
Required materials and conditions: Original bilingual wording and historical verification scope
Materials to obtain first: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation.
Further research: Material needed: Content review of originals, translation, corrections and applicability boundaries is needed. Historical checks are not labeled as current independent clinical validation. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Original bilingual wording and historical verification scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original bilingual wording and historical verification scope with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N20 · Are subclaim values separated from parent scores and axes?

Current findings: Original selected grade D/note and absent subclaim score, status and axes are preserved. Parent C54, Caution, B/S/R1/I2/E+/B2 and unrecorded precision remain parent context; they do not fill subclaim scores, axes or independence certification.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created.
Required materials and conditions: Original subclaim grade/note and absent score, status and axes
Materials to obtain first: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created.
Further research: Material needed: Content review of selected-subclaim and parent original values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Original subclaim grade/note and absent score, status and axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score, status and axes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N21 · Are the evidence date and production date distinguished?

Current findings: Original evidence date 2026-09-07, empty corrections array and empty deliberation string are retained. This is not the current production/review date or certification that no external corrections exist.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled.
Required materials and conditions: Original evidence date, correction and deliberation records
Materials to obtain first: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled.
Further research: Material needed: Actual new corrections, follow-up material, complete pre-change originals and change history are needed. Existing dates and empty records are not arbitrarily filled. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Original evidence date, correction and deliberation records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original evidence date, correction and deliberation records with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N22 · Are public funding and company-related dimensions separated?

Current findings: Original funding records public/nonprofit support including NIH and the American Heart Association. This does not separately verify device/product support, company-employee authors or company involvement in analysis/reporting.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification.
Required materials and conditions: Funding, product support, employee authors and analysis/reporting roles
Materials to obtain first: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification.
Further research: Material needed: Original funding, COI, device/product support, author affiliations and analysis/publication roles are needed. Parent I2 is not promoted to new independence certification. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Funding, product support, employee authors and analysis/reporting roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Funding, product support, employee authors and analysis/reporting roles with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N23 · Are randomization, masking, measurement and selective reporting detailed?

Current findings: The original design is randomized with low-resistance sham control. Allocation concealment, participant/assessor masking, pressure/FMD measurements, missingness and selective-reporting details are separately unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review.
Required materials and conditions: Sham-controlled design, bias and prior plans
Materials to obtain first: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review.
Further research: Material needed: Original methods, registration, protocol, SAP, measurements, denominators and change history are needed. A design label does not certify official RoB/GRADE assessment or passed review. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Sham-controlled design, bias and prior plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Sham-controlled design, bias and prior plans with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N24 · Are actual exposure, adherence and concurrent care verified?

Current findings: Original exposure and directional adherence statements remain study-identification context. Actual breathing/resistance exposure, intervention deviations, baseline/follow-up medication, diet/activity changes and detailed denominators are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created.
Required materials and conditions: Study identification versus actual exposure and cointerventions
Materials to obtain first: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created.
Further research: Material needed: Original actual exposure, adherence, concurrent care, missingness and intervention deviations are needed. No new total-exposure/frequency calculations, device/breathing-training or medication-change instructions are created. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Study identification versus actual exposure and cointerventions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Study identification versus actual exposure and cointerventions with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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N25 · Are possible harms separated from observed event counts?

Current findings: The original describes possible neck discomfort/dizziness and boundaries for certain cardiopulmonary conditions/symptoms. Possibilities do not all establish observed events; counts, incidence, collection methods, exposure denominators and CIs are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification.
Required materials and conditions: Original caution statements and actual harm collection/denominators
Materials to obtain first: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification.
Further research: Material needed: Original adverse-event definitions, active collection, arm-specific exposure/denominators, withdrawal, comparator and severity tables are needed. Caution is not changed into absence of harm or new safety certification. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Original caution statements and actual harm collection/denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original caution statements and actual harm collection/denominators with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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N26 · Are long-term, rare harms and applicability verified?

Current findings: A six-week completer pressure study is not extended to rare-harm rates, long-term events or safety of medication replacement. Original boundaries concerning cardiopulmonary disease, chest pain and presyncope are existing statements, not new treatment decisions or procedures.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events.
Required materials and conditions: Six-week selected adults versus long-term harms
Materials to obtain first: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events.
Further research: Material needed: Actual long-term follow-up, diseases, eligibility, harm surveillance, exposure/risk time, arm denominators and CIs are needed. Unverified does not become safe or zero events. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Six-week selected adults versus long-term harms must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Six-week selected adults versus long-term harms with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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N27 · Which materials would trigger an update?

Current findings: This sheet organizes stored material concerning DBP and cardiovascular events. Related observations can be updated after content review of original reports, between-group effects, denominators, prior plans, endpoints, times, follow-up, support and harm data.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: 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.
Reason for missing information: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished.
Required materials and conditions: Separating originals, applied conditions, observations and verdict changes
Materials to obtain first: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished.
Further research: Material needed: Complete pre-change preservation, original/condition versions, separate application and content-review records are needed. Material updates and verdict changes are distinguished. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Material for Separating originals, applied conditions, observations and verdict changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Separating originals, applied conditions, observations and verdict changes with the selected DBP/cardiovascular-event question, same report/population, high resistance versus low-resistance sham, within-arm versus between-group results, endpoints, times, denominators and harms.
Application exceptions: Preserve original numbers and study exposure only. Distinguish selected original grade D, null DBP P=.17 and unmeasured cardiovascular events; neither is filled as zero effect, equivalence or zero events. Parent SBP within-arm 9 mmHg, crude difference 6 mmHg and P=.02 versus adjusted between-group effects/CIs, ambulatory SBP P=.07, approximately 45% relative FMD change, and 38 randomized/36 analyzed remain separate. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, breathing methods, device settings, training or treatment-replacement instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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