Kyolic Reserve aged garlic extract 1.2 g/day, providing 1.2 mg/day S-allylcysteine × Reduction of office systolic blood pressure in uncontrolled hypertension

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	Met	Full text not readStored summary read	N01 · Evidence conditionWhat is this sheet's independent question?Required	The retained effect is lower office systolic blood pressure in uncontrolled hypertension; the scope note limits the question to AGE 1.2 g/SAC 1.2 mg and 12-week SBP. S01	The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.	The 12-week office-SBP comparison after adding Kyolic Reserve AGE 1.2 g/SAC 1.2 mg/day in 2 capsules to stable care, or in untreated adults as described in the retained record, with exact source locations.	Material needed: An original report specifying population, formulation, endpoint, timing and comparison, plus a separate boundary review, would be needed to change the scope. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the report and the same group's background dose study distinguished?Required	The retained 1 evidence entry/1 citation identifies the AGE at Heart report; the same group's dose study and other products mentioned in the counterview lack separate bibliography or data by group. S01	The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.	Identity of the AGE at Heart 1 evidence entry/1 citation, and its relationship to earlier studies or other aged-black-garlic products.	Material needed: Original trial registration ID, related-report list, and exact bibliography and formulation tables for the earlier dose study and other black-garlic products. This records needed materials; no new research was executed.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWere the summary, PubMed, DOI, PMC, supplements and registration actually read in this preparation?Required	The retained evidence and bibliography were read. PMID 26869811, PMCID PMC4734812 and DOI entries are provided as links; there were 0 external readings in this preparation. S01	The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.	Local acquisition, external existence/access, reading level, dates and exact locations for each material.	Material needed: Actual access/acquisition/reading records, original paper/supplement bytes, versions and checked locations. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow is the population on stable medication or no treatment retained?Required	The Korean population includes adults maintaining stable medication or receiving no treatment; the English text says stable therapy or no planned medication change. S01	The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.	Uncontrolled hypertension, eligibility/exclusion criteria, baseline SBP, age, existing medication use and composition by group.	Material needed: Eligibility table, baseline tables by group, proportions untreated/on medication and conditions for permitted medication changes. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat is the formulation contract for AGE, SAC, two capsules and matching placebo?Required	The retained population/intervention fields specify Kyolic Reserve capsules providing AGE 1.2 g/SAC 1.2 mg/day in 2 capsules, versus matching placebo plus existing care. S01	The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.	Kyolic Reserve extract powder from Allium sativum cloves aged in aqueous ethanol; AGE 1.2 g/SAC 1.2 mg/day, 2 capsules and placebo.	Material needed: Trial-product batch and content specifications, placebo composition, administration verification and remaining-capsule records. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich measurement, time point and analysis does the 12-week office-SBP value represent?Required	The evidence endpoint is 12-week office SBP; the Korean/English reader answers report an adjusted between-group contrast of −5.0±2.1 mmHg (P=.016). S01	Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.	Office systolic pressure in mmHg, the adjusted between-group change from baseline at 12 weeks and its analysis definition.	Material needed: 12-week result table, definitions of baseline/final/change values, measurement frequency/equipment and adjustment variables. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhich denominators do 88 completers and 84 in the adjusted analysis represent?Required	The original count is 88 completers and 84 in the adjusted analysis; the reader answer notes limitations from protocol-related exclusions. S01	Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.	Total randomized and allocated/completed/analyzed counts by group, reasons for exclusion/missingness and uncertainty intervals.	Material needed: CONSORT flowchart, analysis tables by group, reasons for protocol exclusions, missing-data handling and CIs. This records needed materials; no new research was executed.
8	Met	Full text not readStored summary read	N08 · Evidence conditionAre DBP, central pressure and responder signals kept separate from the main SBP result?Required	The Korean/English explanation states that larger responder reductions, DBP and central pressure were not merged into the main claim. S01	The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.	Boundaries between the overall adjusted SBP estimate and secondary/subgroup results, including contrary or no-difference information.	Material needed: Complete results by endpoint, subgroup definitions/denominators, prespecified plans and interactions. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat are the original review date and the scope of this reading?Required	The retained review date is 2026-09-08 and the correction date is 2026-09-14; this preparation converts an actual reading of the current retained material. S01	Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.	The retained review date 2026-09-08, correction date, current reading date, retained inputs, search cutoff and individual access dates.	Material needed: Historical search strategy/cutoff, material-specific access history and later publication/correction lists. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionHow far was the wording about a blood-pressure meta-analysis retracted in 2026 verified?Supplementary; required for a retraction-update claim	The Korean/English research description contains a historical statement about excluding a blood-pressure meta-analysis retracted in 2026, but the evidence/citation entries do not identify it. S01	The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.	Publication ID, retraction notice, affected results and original exclusion decision for that meta-analysis.	Material needed: Exact DOI/PMID, retraction notice, original report and documented exclusion reason. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionDo company funding, capsule provision and a no-involvement declaration mean the same thing?Supplementary; required for an independence claim	The retained funding entry states Wakunaga of America research funding and capsule provision, with a declaration of no involvement in design/analysis; the historical independence axis is I0. S01	The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.	Wakunaga of America funding/product provision, roles in design/analysis, author roles and declared conflicts.	Material needed: Original funding/COI statements, product-support information, author employment/institutions and analysis-responsibility documents. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs implementation of the double-blind randomized placebo-controlled design verified?Required	The retained Korean/English design fields describe a randomized, double-blind, placebo-controlled study. S01	Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.	Allocation method, concealment, baseline balance, who was blinded, maintenance of blinding and actual design.	Material needed: Methods section, allocation/concealment procedures, baseline table and blinding assessment. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWere concomitant antihypertensives, changes and adherence mixed with the AGE contribution?Required	The population/intervention fields and central explanation describe AGE added to stable existing treatment; the Korean population also includes untreated adults. S01	Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.	Group composition on existing care/no treatment, drug types/doses, changes/rescue treatment, AGE adherence and analysis handling.	Material needed: Medication lists/changes by group, adherence, rescue treatment and deviation analyses. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionCan office-SBP measurement error and assessor blinding be assessed?Required	The retained material provides only 12-week office SBP and a double-blind design label. S01	Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.	Equipment, posture, rest, repeated measurements, timing, assessor blinding and differences between groups.	Material needed: Blood-pressure measurement protocol, assessor/equipment validation and original measurement tables. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhich effect does the adjusted analysis of 84 participants estimate?Required	The reader answer reports an adjusted group contrast and limitations from protocol-related exclusions; the evidence count reports 84 in the adjusted analysis. S01	Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.	Effect of assignment/adherence, ITT/PP, exclusion criteria, adjustment variables and definition of the group contrast.	Material needed: SAP, analysis-set definitions, exclusion reasons, adjustment model and ITT/sensitivity tables. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionIs there material to interpret the precision of −5.0±2.1 mmHg and P=.016?Required	The retained result is a between-group −5.0±2.1 mmHg, P=.016; the Korean/English reader answers call it an adjusted contrast. S01	The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.	Between-group estimate, whether ±2.1 is SD/SE/CI, confidence interval, group-specific changes and justified clinical importance.	Material needed: Original result table, variance definition, CI, changes by group and basis for clinical importance. This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionDo the prespecified endpoint/analysis plan and reporting agree for 12-week SBP?Required	The retained registration field says not verified, while the research description contains a historical statement about comparing the AGE at Heart paper and registration. S01	Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.	Original trial registration, protocol, SAP, endpoint hierarchy and analysis/time-point changes.	Material needed: Exact registration identifier, protocol/SAP versions and a results/change comparison table. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIs independent replication verified for the same formulation, dose, population and 12-week SBP?Required	The counterview says the same group's dose study and another aged-black-garlic product do not establish formulation- and funding-independent replication. S01	The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.	Unique study families, independence of formulation/funding/team and trial-specific estimates.	Material needed: Bibliography/registration, exact formulations, institutions/funding and individual results for the earlier study and other products. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionCan AGE 1.2 g and SAC 1.2 mg be interpreted as the optimal dose?Supplementary; required for an expanded dose claim	The retained selected amount is AGE 1.2 g/SAC 1.2 mg/day in 2 capsules; the same group's earlier dose study appears only in background wording. S01	The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.	Direct dose comparisons, product specifications, estimates/harms by dose and prespecified analysis.	Material needed: Exact bibliography of the earlier dose trial, group counts by dose, effects/CIs and support information. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionDoes this answer persistence, effects after stopping or longer-term pressure beyond 12 weeks?Supplementary; required for a persistence claim	The retained duration is 12 weeks of treatment and 12 weeks of follow-up; the scope note also limits the claim to 12-week SBP. S01	Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.	Long-term/post-discontinuation follow-up, persistence in the same population/intervention/comparison and medication changes/adherence.	Material needed: Long-term/post-discontinuation results, treatment changes by group, missingness and adherence. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionCan a larger decrease in responders be read as the overall effect?Supplementary; required for an expanded subgroup claim	The Korean/English explanation records that larger reductions in the responder subgroup were not merged into the main claim. S01	Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.	Responder definition, prespecified plan, subgroup count, group contrast/CI and interaction.	Material needed: Responder criteria, SAP, subgroup denominators/results and effect-modification tests. This records needed materials; no new research was executed.
22	Met	Full text not readStored summary read	N22 · Evidence conditionDoes the office-SBP difference directly answer cardiovascular-event prevention?Supplementary; required for extension to clinical events	The retained advertising explanation says the result cannot be extended to all garlic products or cardiovascular-event prevention. S01	The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.	Boundary between SBP results and myocardial infarction, stroke, death or quality of life.	Material needed: Population, formulation, follow-up, event counts/denominators and analysis in separate direct event studies. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAt what level is safety for the same AGE exposure reported?Supplementary; required for a safety claim	The historical safety label is Caution, with cautions about hypotension/dizziness when combined with antihypertensives and perioperative or anticoagulant/antiplatelet use. S01	The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.	Adverse events/discontinuations, collection, denominators by group and observation time for the same formulation over 12 weeks.	Material needed: Trial-specific AE/SAE and discontinuation tables, collection methods and exposure denominators by group. This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionAre event definitions and collection recorded for hypotension, dizziness or bleeding?Supplementary; required for a direct harm question	The retained safety details contain cautions but no trial event table. S01	Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.	Trial event definitions, severity, systematic collection, discontinuations and ascertainment methods.	Material needed: AE definitions, collection forms, severity/discontinuation records and assessment tables. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionIs the timing of the cautioned events relative to AGE exposure recorded?Supplementary; required for a harm-causality question	The efficacy duration is 12 weeks, but the retained material provides no event-specific harm timelines. S01	Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.	Start/stop of use, event onset/recovery, re-exposure and latency.	Material needed: Individual harm timelines, discontinuation/recovery/re-exposure and exposure-duration records. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWas the placebo comparison also used for an actual harm estimate?Supplementary; required for a comparative harm claim	The original comparator is matching placebo plus existing blood-pressure care; the retained material contains no comparative harm results. S01	Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.	AGE/placebo adverse events, background treatment and comparative estimates.	Material needed: AE results and denominators by group, harm estimates/intervals and concomitant care. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre exposure and event denominators available for harm frequency?Supplementary; required for a harm-frequency claim	The current counts of 88 completers and 84 in the adjusted analysis concern efficacy; harm denominators are not specified. S01	Harm-exposure denominators, event counts and time-specific estimates remain unverified.	Exposed participants by group, people/events, observation time and recruitment/reporting system.	Material needed: AE exposure denominators by group, people/event counts and follow-up time. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionIs there material to attribute hypotension/dizziness during combined antihypertensive and AGE use?Supplementary; required for causality of harms with combined use	The original safety details advise monitoring for hypotension and dizziness with existing antihypertensives. S01	The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.	Medication types/doses, actual AGE exposure, baseline pressure, concurrent changes and event-specific alternatives.	Material needed: Medication changes by group, symptom timing, baseline values and harms by concomitant treatment. This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat direct material supports cautions about surgery or anticoagulant/antiplatelet use?Supplementary; required for a bleeding/perioperative harm claim	The original safety details contain cautions about perioperative or anticoagulant/antiplatelet use. S01	Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.	Perioperative exposure, concomitant medication, bleeding events and alternative causes for the same formulation/dose.	Material needed: Surgery timing, concomitant medication, exposure, bleeding definitions/denominators and original reports for the same formulation. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionCan the relationship between follow-up loss, protocol exclusions and missing harms be verified?Supplementary; required for completeness of harm collection	The protocol-exclusion limitation in the reader answer and the counts of 88 completers/84 in the adjusted analysis are retained. S01	Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.	Recruitment/reporting, exclusions/losses by group, stopping harm collection and scope of complete event disclosure.	Material needed: Reasons for losses/exclusions by group, AE-related discontinuations and completeness of follow-up/reporting. This records needed materials; no new research was executed.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionWere the cautioned events repeated in independent material?Supplementary; required for a repeated-harm claim	The retained evidence/citation entries identify 1 report; there is no bibliography for separate harm reports or regulatory material. S01	Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.	Unique harm reports/studies, exact formulation/dose, events and re-citation/regulatory relationships.	Material needed: Identified direct harm reports, original registration/regulatory material and a re-citation family map. This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionIs safety established for rare or long-term harms and vulnerable groups beyond 12 weeks?Supplementary; required for long-term/vulnerable-group safety	The current exposure period is 12 weeks, and the original caution mentions combined use and surgery. S01	The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.	Long-term/rare events, baseline risks, vulnerable groups, concomitant/perioperative exposures and follow-up.	Material needed: Direct material on long-term exposure/rare events and older adults, underlying disease or concomitant/perioperative use. This records needed materials; no new research was executed.
33	Met	Full text not readStored summary read	N33 · Evidence conditionDoes the original caution concern signals, comparative risk or causality?Supplementary; required for harm interpretation	The original Caution label, C50 and all axes are retained historical values; direct information on harm occurrence or causality was not verified. S01	The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.	Direct design, events, denominators, timing, comparison, alternatives and the scope of currently possible statements.	Material needed: An exact harm question, original event tables and direct comparative/timing/alternative-explanation material. This records needed materials; no new research was executed.

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33 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-06
Original evidence cut-off: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
Population: Adults with uncontrolled hypertension. The retained Korean description includes stable antihypertensive use or no treatment; the retained English description says stable treatment or no planned medication change. This does not establish that everyone took antihypertensives. Age, eligibility criteria, baseline pressure and medication composition by group remain unverified.
Ingredient, formulation and route: Kyolic Reserve capsules containing extract powder made from Allium sativum cloves aged in aqueous ethanol. AGE mass and SAC marker content remain distinct; other garlic products and isolated SAC are not interchangeable.
Dose: 2 capsules daily, providing AGE 1.2 g and SAC 1.2 mg/day. These are retained trial formulation and dose descriptions, without establishing an optimal dose or a personal dosing recommendation. Batch, measured content, administration timing and adherence remain unverified.
Comparator: The comparator is matching placebo plus existing blood-pressure care. The retained record describes adding the product to existing care. Actual background drug types, doses, balance between groups, changes and rescue treatment remain unverified; this does not establish replacement of antihypertensive medication.
Measured outcome: The endpoint is the adjusted between-group change from baseline in office systolic blood pressure at 12 weeks. The retained reported estimate is −5.0±2.1 mmHg, P=.016. Whether ±2.1 denotes SD, SE or a CI, the confidence interval, measurement procedure and adjustment model remain unverified. Within-group changes, DBP, central pressure, responder subgroups and clinical events are kept separate.
Duration: 12 weeks of treatment and 12 weeks of follow-up. This does not establish longer-term persistence after treatment, effects after stopping, or long-term and rare harms.
Questions outside this scope: Efficacy of other formulations, including raw garlic, garlic powder, garlic oil, stabilized allicin, black garlic, fermented garlic and isolated SAC; Optimal dose, higher or lower doses and personal dosing instructions; Replacing the overall effect with a larger reduction in a responder subgroup; Extension to DBP, central pressure, 24-hour blood pressure or cardiovascular-event prevention; Replacement of antihypertensives or an assertion that all participants took them; Persistence beyond 12 weeks, effects after stopping, or overall safety in long-term use or vulnerable groups; Counting unidentified earlier studies, other products or the retraction narrative as new direct reports or independent replication

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.

S01 · Ried K et al. Integr Blood Press Control. 2016;9:9-21. PMID: 26869811. PMCID: PMC4734812. DOI: 10.2147/IBPC.S93335.

PubMed

Material type: Retained summary and bibliography for the direct AGE at Heart trial
Materials actually read: Retained Korean/English summaries, conditions and application records were read. External PubMed, DOI, PMC, registration and supplement material remain unread, with access not attempted.
Findings recorded in the stored summary: The retained reported adjusted between-group office-SBP contrast at 12 weeks is −5.0±2.1 mmHg, P=.016. The 88 completers and 84 participants in the adjusted analysis remain distinct. The type of ±2.1, CI, allocation/analysis counts by group, full ITT status, exclusion rules and adjustment model remain unverified. Research funding and capsule provision are distinguished from the declaration of no involvement in design or analysis; the declaration alone does not certify independent support or absence of bias.
Record level: These are retained reported values and limitations, without a new external full-text check, numerical recalculation or new verdict.
Study overlap and independent replication: The evidence entry and bibliography identify 1 AGE at Heart report. Korean/English wording, synthesis, DBP, central-pressure and responder results, and DOI/PMC entry links are not independent trials. The identities, overlap and independence of the same group’s earlier dose study, other black-garlic products and the unidentified retraction narrative, as well as unique study and participant totals, remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored review summary	Locally retained summary	Acquired	Stored existing review summary read	The retained Korean/English evidence and bibliographic summaries were read. This does not mean the original paper file was acquired or its full text newly verified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
External bibliography/abstract	Unverified	Access not attempted	Not read	The retained PubMed address is provided. Current responses, new reading of the abstract/bibliography and successful external access remain unverified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
DOI full-text entry	Unverified	Access not attempted	Not read	This is the retained DOI entry for full text. Existence, public availability, access, downloading and reading of full text or supplements remain unverified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
Original trial registration	Unverified	Access not attempted	Not read	The structured registration status is not verified. The exact registration location, original record, prespecified endpoint, protocol and analysis plan remain unverified. This does not establish non-registration. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
PMC full-text entry	Unverified	Access not attempted	Not read	This is the PMC entry for the retained PMCID. It concerns the same report as the DOI entry and is not an independent trial. Full text, responses, downloading and accessibility were not checked in this preparation. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.
Original-paper supplement	Unverified	Access not attempted	Not read	The existence, exact location and original file of a supplement remain unverified. Non-reading does not establish absence of a supplement or a failed access attempt. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff.

Report counts versus independent study counts

The evidence entry and bibliography identify 1 AGE at Heart report. Korean/English wording, synthesis, DBP, central-pressure and responder results, and DOI/PMC entry links are not independent trials. The identities, overlap and independence of the same group’s earlier dose study, other black-garlic products and the unidentified retraction narrative, as well as unique study and participant totals, remain unverified.

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 · What is this sheet's independent question?

Required materials and conditions: The 12-week office-SBP comparison after adding Kyolic Reserve AGE 1.2 g/SAC 1.2 mg/day in 2 capsules to stable care, or in untreated adults as described in the retained record, with exact source locations.
Conditions for verification: Link the original Korean claim and both language versions of the population/intervention fields to the formulation, dose, 12-week period and placebo comparison as a single question.
Requirement and applicability: Required
Application exceptions: DBP, central pressure and responder results must not replace the main effect or automatically become new sheets.
Why this condition is needed: Needed to keep other formulations, endpoints and time periods on the garlic page separate from the main SBP question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N02 · How are the report and the same group's background dose study distinguished?

Required materials and conditions: Identity of the AGE at Heart 1 evidence entry/1 citation, and its relationship to earlier studies or other aged-black-garlic products.
Conditions for verification: Link the S01 evidence entry and citation to the same report; leave unidentified background material separately unverified.
Requirement and applicability: Required
Application exceptions: Background wording alone must not generate S02, a new direct trial or a unique-participant total.
Why this condition is needed: Needed to avoid counting the evidence table, both languages, synthesis and same-group narrative repeatedly as independent replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N03 · Were the summary, PubMed, DOI, PMC, supplements and registration actually read in this preparation?

Required materials and conditions: Local acquisition, external existence/access, reading level, dates and exact locations for each material.
Conditions for verification: Record only the current retained material as summary reading; distinguish external entry points, supplements and registration as unread, with access not attempted.
Requirement and applicability: Required
Application exceptions: Access not attempted must not be described as failed access, private availability or absence of the original paper.
Why this condition is needed: Needed to avoid inheriting historical full-text/registration language or links in the research description as current reading.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N04 · How is the population on stable medication or no treatment retained?

Required materials and conditions: Uncontrolled hypertension, eligibility/exclusion criteria, baseline SBP, age, existing medication use and composition by group.
Conditions for verification: Retain both original population descriptions exactly and show unverified eligibility, baseline and composition details.
Requirement and applicability: Required
Application exceptions: Do not assert that everyone took antihypertensives or generalize to other hypertensive or normotensive populations.
Why this condition is needed: Needed to retain both the Korean inclusion of untreated adults and the English stable-therapy/no-planned-medication-change wording.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N05 · What is the formulation contract for AGE, SAC, two capsules and matching placebo?

Required materials and conditions: Kyolic Reserve extract powder from Allium sativum cloves aged in aqueous ethanol; AGE 1.2 g/SAC 1.2 mg/day, 2 capsules and placebo.
Conditions for verification: Retain the nominal product, ingredient amounts, administration frequency, oral add-on use and placebo; distinguish unverified measured specifications and adherence.
Requirement and applicability: Required
Application exceptions: SAC 1.2 mg is the marker content of this formulation; it does not establish isolated-SAC efficacy or equivalence to other products.
Why this condition is needed: Needed to avoid converting AGE mass into SAC marker content or substituting raw garlic, black garlic or isolated SAC.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N06 · Which measurement, time point and analysis does the 12-week office-SBP value represent?

Required materials and conditions: Office systolic pressure in mmHg, the adjusted between-group change from baseline at 12 weeks and its analysis definition.
Conditions for verification: Attribute the value to the adjusted 12-week office-SBP group contrast and retain unverified measurement contract, variance type and model details.
Requirement and applicability: Required
Application exceptions: Generic English principal-endpoint wording must not be promoted to verification of the registered primary endpoint.
Why this condition is needed: Needed to avoid treating within-group reductions, 24-hour pressure, DBP or central pressure as the same effect.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N07 · Which denominators do 88 completers and 84 in the adjusted analysis represent?

Required materials and conditions: Total randomized and allocated/completed/analyzed counts by group, reasons for exclusion/missingness and uncertainty intervals.
Conditions for verification: Retain 88 completers and 84 in the adjusted analysis separately; show unverified group, allocation and loss information.
Requirement and applicability: Required
Application exceptions: Do not add 88 and 84 or assume 44/42 per group or a unique-participant total.
Why this condition is needed: Needed to avoid substituting completed/analyzed denominators for randomized, ITT or group-specific denominators.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N08 · Are DBP, central pressure and responder signals kept separate from the main SBP result?

Required materials and conditions: Boundaries between the overall adjusted SBP estimate and secondary/subgroup results, including contrary or no-difference information.
Conditions for verification: Keep other endpoints and responder values separate from the main SBP estimate; retain unverified specific results and hierarchy.
Requirement and applicability: Required
Application exceptions: Mention of other results in the original explanation must not become a new conclusion of no DBP effect or conflicting data.
Why this condition is needed: Needed to prevent favorable subgroup values from replacing the overall main estimate.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N09 · What are the original review date and the scope of this reading?

Required materials and conditions: The retained review date 2026-09-08, correction date, current reading date, retained inputs, search cutoff and individual access dates.
Conditions for verification: Separate original dates from current local checks and limit statements of absence to the retained material.
Requirement and applicability: Required
Application exceptions: 0 new searches must not be described as 0 studies or no subsequent material.
Why this condition is needed: Needed to avoid turning the retained manuscript-review date into a current clinical-search cutoff or current full-text access date.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N10 · How far was the wording about a blood-pressure meta-analysis retracted in 2026 verified?

Required materials and conditions: Publication ID, retraction notice, affected results and original exclusion decision for that meta-analysis.
Conditions for verification: Quote only the historical exclusion statement; leave current verification of the publication and retraction notice unverified.
Requirement and applicability: Supplementary; required for a retraction-update claim
Application exceptions: Do not add an unidentified meta-analysis as S02, an independent trial or a main SBP result.
Why this condition is needed: Needed to avoid promoting an unidentified historical exclusion statement into a currently verified retraction or new report.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N11 · Do company funding, capsule provision and a no-involvement declaration mean the same thing?

Required materials and conditions: Wakunaga of America funding/product provision, roles in design/analysis, author roles and declared conflicts.
Conditions for verification: Retain research funding, capsule provision and the no-involvement declaration separately; show unverified COI and institutional/author roles.
Requirement and applicability: Supplementary; required for an independence claim
Application exceptions: Do not delete the original effect solely because support exists or newly certify the support declaration.
Why this condition is needed: Needed to avoid converting company support into independent funding or the no-involvement declaration alone into absence of bias.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N12 · Is implementation of the double-blind randomized placebo-controlled design verified?

Required materials and conditions: Allocation method, concealment, baseline balance, who was blinded, maintenance of blinding and actual design.
Conditions for verification: Distinguish the retained design description from unverified implementation material.
Requirement and applicability: Required
Application exceptions: Do not fill unverified parallel/crossover/cluster design details with an arbitrary not-applicable status or a definite design.
Why this condition is needed: A design label alone cannot establish that allocation or confounding issues were resolved.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N13 · Were concomitant antihypertensives, changes and adherence mixed with the AGE contribution?

Required materials and conditions: Group composition on existing care/no treatment, drug types/doses, changes/rescue treatment, AGE adherence and analysis handling.
Conditions for verification: Separate the stable-care plan from verified levels of actual changes and adherence by group.
Requirement and applicability: Required
Application exceptions: Do not describe an add-on trial as antihypertensive replacement or assume that every participant took medication.
Why this condition is needed: Needed to avoid attributing contributions from changes in other medication to the AGE 1.2 g effect.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N14 · Can office-SBP measurement error and assessor blinding be assessed?

Required materials and conditions: Equipment, posture, rest, repeated measurements, timing, assessor blinding and differences between groups.
Conditions for verification: Describe actual SBP procedures and conditions by group only to the level verified.
Requirement and applicability: Required
Application exceptions: Do not assume absence of measurement bias because the outcome is a numerical measurement.
Why this condition is needed: A double-blind design label does not automatically establish standardized pressure measurement or verified assessor blinding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N15 · Which effect does the adjusted analysis of 84 participants estimate?

Required materials and conditions: Effect of assignment/adherence, ITT/PP, exclusion criteria, adjustment variables and definition of the group contrast.
Conditions for verification: Retain the adjusted contrast and 84 analyzed as originally worded; show unverified analysis-set and model details.
Requirement and applicability: Required
Application exceptions: Mention of protocol exclusions alone must not newly establish a complete PP model or post hoc selection.
Why this condition is needed: Needed to avoid promoting 88 completers and the estimate in 84 after protocol exclusions into full ITT.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N16 · Is there material to interpret the precision of −5.0±2.1 mmHg and P=.016?

Required materials and conditions: Between-group estimate, whether ±2.1 is SD/SE/CI, confidence interval, group-specific changes and justified clinical importance.
Conditions for verification: Retain the original effect, P value and units; explain unverified uncertainty bounds and importance.
Requirement and applicability: Required
Application exceptions: Do not read ± as a CI or calculate a new confidence interval, values by group, minimum sample size or importance threshold.
Why this condition is needed: The P value and sample size alone cannot establish sufficient effect magnitude, precision or clinical meaning.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N17 · Do the prespecified endpoint/analysis plan and reporting agree for 12-week SBP?

Required materials and conditions: Original trial registration, protocol, SAP, endpoint hierarchy and analysis/time-point changes.
Conditions for verification: Retain both the original registration field and historical narrative; show unverified comparison against actual prespecified plans.
Requirement and applicability: Required
Application exceptions: A not-verified registration field does not establish non-registration or selective reporting.
Why this condition is needed: Needed to avoid inheriting a historical paper/registration comparison narrative as current reading of the registry or SAP.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N18 · Is independent replication verified for the same formulation, dose, population and 12-week SBP?

Required materials and conditions: Unique study families, independence of formulation/funding/team and trial-specific estimates.
Conditions for verification: Retain the distinction between S01 and background wording; leave independent replication and unique study counts unverified.
Requirement and applicability: Required
Application exceptions: Do not automatically inherit the historical R1/I0 axes as new condition statuses or new replication counts.
Why this condition is needed: Needed to avoid counting the same-group dose study and another black-garlic product as independent replication of the matched product.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N19 · Can AGE 1.2 g and SAC 1.2 mg be interpreted as the optimal dose?

Required materials and conditions: Direct dose comparisons, product specifications, estimates/harms by dose and prespecified analysis.
Conditions for verification: Distinguish the selected dose from unverified optimal-dose or higher/lower-dose effects.
Requirement and applicability: Supplementary; required for an expanded dose claim
Application exceptions: Do not make all dose trials mandatory for the narrow 12-week SBP question at the exact single dose.
Why this condition is needed: Needed to avoid treating mention of the same group's earlier dose study as certification of an optimal dose.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N20 · Does this answer persistence, effects after stopping or longer-term pressure beyond 12 weeks?

Required materials and conditions: Long-term/post-discontinuation follow-up, persistence in the same population/intervention/comparison and medication changes/adherence.
Conditions for verification: Separate the direct 12-week scope from unverified later persistence.
Requirement and applicability: Supplementary; required for a persistence claim
Application exceptions: Do not make long-term trials automatically mandatory for the narrow 12-week SBP result.
Why this condition is needed: Needed to avoid extending 12-week treatment/follow-up into long-term persistence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N21 · Can a larger decrease in responders be read as the overall effect?

Required materials and conditions: Responder definition, prespecified plan, subgroup count, group contrast/CI and interaction.
Conditions for verification: Distinguish overall SBP from responder signals; show unverified definitions, plans and denominators.
Requirement and applicability: Supplementary; required for an expanded subgroup claim
Application exceptions: Do not require every subgroup validation for the present main question or create a new subgroup-efficacy sheet.
Why this condition is needed: Needed to prevent larger reductions in selected responders from replacing the overall adjusted estimate.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N22 · Does the office-SBP difference directly answer cardiovascular-event prevention?

Required materials and conditions: Boundary between SBP results and myocardial infarction, stroke, death or quality of life.
Conditions for verification: Maintain the current SBP scope and show unverified direct event material.
Requirement and applicability: Supplementary; required for extension to clinical events
Application exceptions: Do not make event trials mandatory for a question about the numerical pressure change itself.
Why this condition is needed: Needed to avoid automatically extending a pressure difference into prevention of clinical events or replacement of treatment.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N23 · At what level is safety for the same AGE exposure reported?

Required materials and conditions: Adverse events/discontinuations, collection, denominators by group and observation time for the same formulation over 12 weeks.
Conditions for verification: Distinguish the original cautions from direct trial harm tables; retain unverified collection and frequency.
Requirement and applicability: Supplementary; required for a safety claim
Application exceptions: Do not delete the retained SBP result because harms remain unverified.
Why this condition is needed: Needed to avoid converting the original caution into observed trial harms or confirmed safety.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N24 · Are event definitions and collection recorded for hypotension, dizziness or bleeding?

Required materials and conditions: Trial event definitions, severity, systematic collection, discontinuations and ascertainment methods.
Conditions for verification: Separate original cautions from the existence or unverified status of event-collection material.
Requirement and applicability: Supplementary; required for a direct harm question
Application exceptions: Monitoring/consultation wording in the original caution alone must not establish actual events or causality.
Why this condition is needed: Needed to avoid converting a general caution into a complete count of diagnosed events.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N25 · Is the timing of the cautioned events relative to AGE exposure recorded?

Required materials and conditions: Start/stop of use, event onset/recovery, re-exposure and latency.
Conditions for verification: Show the 12-week efficacy period separately from harm-specific timing information.
Requirement and applicability: Supplementary; required for a harm-causality question
Application exceptions: Do not infer improvement after discontinuation, re-exposure or individual events when absent.
Why this condition is needed: The 12-week trial duration alone cannot establish temporal order or causality for harms.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N26 · Was the placebo comparison also used for an actual harm estimate?

Required materials and conditions: AGE/placebo adverse events, background treatment and comparative estimates.
Conditions for verification: Separate the placebo contract for SBP from an unverified actual harm-comparison table.
Requirement and applicability: Supplementary; required for a comparative harm claim
Application exceptions: Do not fill cautions lacking a comparison with extrapolated incidence or risk ratios.
Why this condition is needed: Needed to avoid turning the existence of an efficacy placebo into verification of a between-group harm comparison.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N27 · Are exposure and event denominators available for harm frequency?

Required materials and conditions: Exposed participants by group, people/events, observation time and recruitment/reporting system.
Conditions for verification: Report frequency only for reported values linked to the relevant harm denominator and time.
Requirement and applicability: Supplementary; required for a harm-frequency claim
Application exceptions: Do not use efficacy denominators to assert 0 events or calculate incidence/risk differences.
Why this condition is needed: Needed to avoid turning 88 completers/84 in the efficacy analysis into denominators for harm incidence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N28 · Is there material to attribute hypotension/dizziness during combined antihypertensive and AGE use?

Required materials and conditions: Medication types/doses, actual AGE exposure, baseline pressure, concurrent changes and event-specific alternatives.
Conditions for verification: Retain the original hypotension/dizziness caution; show unverified background medication and alternative event information.
Requirement and applicability: Supplementary; required for causality of harms with combined use
Application exceptions: Do not describe the original combined-use caution as an observed trial interaction or an instruction to replace medication.
Why this condition is needed: Needed to avoid attributing medication or baseline-factor contributions solely to AGE causality.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N29 · What direct material supports cautions about surgery or anticoagulant/antiplatelet use?

Required materials and conditions: Perioperative exposure, concomitant medication, bleeding events and alternative causes for the same formulation/dose.
Conditions for verification: Distinguish the original perioperative/combined-use caution from unverified direct trial material.
Requirement and applicability: Supplementary; required for a bleeding/perioperative harm claim
Application exceptions: Retain the caution without creating personal discontinuation or medical instructions.
Why this condition is needed: Needed to avoid certifying a general garlic caution as bleeding causality or incidence in this trial.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N30 · Can the relationship between follow-up loss, protocol exclusions and missing harms be verified?

Required materials and conditions: Recruitment/reporting, exclusions/losses by group, stopping harm collection and scope of complete event disclosure.
Conditions for verification: Separate the original exclusion limitation from direct information on missing harm data.
Requirement and applicability: Supplementary; required for completeness of harm collection
Application exceptions: Do not reclassify efficacy-analysis exclusions as actual harm-related dropouts.
Why this condition is needed: Needed to avoid assuming that the difference between 84 analyzed/88 completed reflects harm-related losses or no events.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N31 · Were the cautioned events repeated in independent material?

Required materials and conditions: Unique harm reports/studies, exact formulation/dose, events and re-citation/regulatory relationships.
Conditions for verification: Distinguish S01 cautions from unverified independent harm families.
Requirement and applicability: Supplementary; required for a repeated-harm claim
Application exceptions: Absence of original harm reports in the retained material must not become a claim of 0 harms worldwide.
Why this condition is needed: Needed to avoid counting general cautions, the same report or another black-garlic product as repeated independent signals.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N32 · Is safety established for rare or long-term harms and vulnerable groups beyond 12 weeks?

Required materials and conditions: Long-term/rare events, baseline risks, vulnerable groups, concomitant/perioperative exposures and follow-up.
Conditions for verification: Distinguish the present duration/population from unverified long-term or special-exposure scopes.
Requirement and applicability: Supplementary; required for long-term/vulnerable-group safety
Application exceptions: Do not make all vulnerable-group/rare-harm material mandatory for the narrow SBP-efficacy question.
Why this condition is needed: Needed to avoid extending a small 12-week efficacy record into overall safety.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N33 · Does the original caution concern signals, comparative risk or causality?

Required materials and conditions: Direct design, events, denominators, timing, comparison, alternatives and the scope of currently possible statements.
Conditions for verification: Retain original C50/Caution/axes only as historical quotations and distinguish unverified direct harms.
Requirement and applicability: Supplementary; required for harm interpretation
Application exceptions: Do not create medical dosing instructions or new efficacy/safety scores or grades.
Why this condition is needed: Needed to avoid turning the original caution or positive efficacy result into a safety grade, risk magnitude or established causality.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

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: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Partly verified: Some retained information is verified and necessary unverified material remains.
Unverified: The criterion could not be established within the retained material. This does not mean no studies, no effect or established safety.
Review incomplete: The necessary source comparison or search was not performed within the authorized scope.
Not reported: This is limited to the item not being stated in the particular material or section that was read.
Inaccessible: Used only for material where an actual access attempt failed. This status was not assigned to clinical material in this preparation.
Insufficient evidence for the conditions: Used only after relevant studies within the defined scope have been reviewed and evidence is insufficient to answer the condition. It was not applied to every item in this preparation.
Not applicable: A specific exception under the applicability conditions; it is not a substitute for material remaining unread.
Conflicting data: Used when incompatible material has been compared for the same question, time point and analysis. Numerical differences between summaries alone do not establish this status.
Met: The stated conditions for retained information, attribution, reading, counting or interpretation boundaries are verified. This is not certification of efficacy, full-text reading or reassessment.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-06) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

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

View all item details

N01 · What is this sheet's independent question?

Current findings: The retained effect is lower office systolic blood pressure in uncontrolled hypertension; the scope note limits the question to AGE 1.2 g/SAC 1.2 mg and 12-week SBP.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.
Reason for missing information: The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.
Required materials and conditions: The 12-week office-SBP comparison after adding Kyolic Reserve AGE 1.2 g/SAC 1.2 mg/day in 2 capsules to stable care, or in untreated adults as described in the retained record, with exact source locations.
Materials to obtain first: An original report specifying population, formulation, endpoint, timing and comparison, plus a separate boundary review, would be needed to change the scope.
Further research: Material needed: An original report specifying population, formulation, endpoint, timing and comparison, plus a separate boundary review, would be needed to change the scope. This records needed materials; no new research was executed.
Remaining uncertainty: The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.
Conditions for verification: Link the original Korean claim and both language versions of the population/intervention fields to the formulation, dose, 12-week period and placebo comparison as a single question.
Why this condition is needed: Needed to keep other formulations, endpoints and time periods on the garlic page separate from the main SBP question.
Application exceptions: DBP, central pressure and responder results must not replace the main effect or automatically become new sheets.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N02 · How are the report and the same group's background dose study distinguished?

Current findings: The retained 1 evidence entry/1 citation identifies the AGE at Heart report; the same group's dose study and other products mentioned in the counterview lack separate bibliography or data by group.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.
Reason for missing information: The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.
Required materials and conditions: Identity of the AGE at Heart 1 evidence entry/1 citation, and its relationship to earlier studies or other aged-black-garlic products.
Materials to obtain first: Original trial registration ID, related-report list, and exact bibliography and formulation tables for the earlier dose study and other black-garlic products.
Further research: Material needed: Original trial registration ID, related-report list, and exact bibliography and formulation tables for the earlier dose study and other black-garlic products. This records needed materials; no new research was executed.
Remaining uncertainty: The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.
Conditions for verification: Link the S01 evidence entry and citation to the same report; leave unidentified background material separately unverified.
Why this condition is needed: Needed to avoid counting the evidence table, both languages, synthesis and same-group narrative repeatedly as independent replication.
Application exceptions: Background wording alone must not generate S02, a new direct trial or a unique-participant total.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N03 · Were the summary, PubMed, DOI, PMC, supplements and registration actually read in this preparation?

Current findings: The retained evidence and bibliography were read. PMID 26869811, PMCID PMC4734812 and DOI entries are provided as links; there were 0 external readings in this preparation.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.
Reason for missing information: The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.
Required materials and conditions: Local acquisition, external existence/access, reading level, dates and exact locations for each material.
Materials to obtain first: Actual access/acquisition/reading records, original paper/supplement bytes, versions and checked locations.
Further research: Material needed: Actual access/acquisition/reading records, original paper/supplement bytes, versions and checked locations. This records needed materials; no new research was executed.
Remaining uncertainty: The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.
Conditions for verification: Record only the current retained material as summary reading; distinguish external entry points, supplements and registration as unread, with access not attempted.
Why this condition is needed: Needed to avoid inheriting historical full-text/registration language or links in the research description as current reading.
Application exceptions: Access not attempted must not be described as failed access, private availability or absence of the original paper.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N04 · How is the population on stable medication or no treatment retained?

Current findings: The Korean population includes adults maintaining stable medication or receiving no treatment; the English text says stable therapy or no planned medication change.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.
Reason for missing information: The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.
Required materials and conditions: Uncontrolled hypertension, eligibility/exclusion criteria, baseline SBP, age, existing medication use and composition by group.
Materials to obtain first: Eligibility table, baseline tables by group, proportions untreated/on medication and conditions for permitted medication changes.
Further research: Material needed: Eligibility table, baseline tables by group, proportions untreated/on medication and conditions for permitted medication changes. This records needed materials; no new research was executed.
Remaining uncertainty: The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.
Conditions for verification: Retain both original population descriptions exactly and show unverified eligibility, baseline and composition details.
Why this condition is needed: Needed to retain both the Korean inclusion of untreated adults and the English stable-therapy/no-planned-medication-change wording.
Application exceptions: Do not assert that everyone took antihypertensives or generalize to other hypertensive or normotensive populations.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N05 · What is the formulation contract for AGE, SAC, two capsules and matching placebo?

Current findings: The retained population/intervention fields specify Kyolic Reserve capsules providing AGE 1.2 g/SAC 1.2 mg/day in 2 capsules, versus matching placebo plus existing care.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.
Reason for missing information: The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.
Required materials and conditions: Kyolic Reserve extract powder from Allium sativum cloves aged in aqueous ethanol; AGE 1.2 g/SAC 1.2 mg/day, 2 capsules and placebo.
Materials to obtain first: Trial-product batch and content specifications, placebo composition, administration verification and remaining-capsule records.
Further research: Material needed: Trial-product batch and content specifications, placebo composition, administration verification and remaining-capsule records. This records needed materials; no new research was executed.
Remaining uncertainty: The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.
Conditions for verification: Retain the nominal product, ingredient amounts, administration frequency, oral add-on use and placebo; distinguish unverified measured specifications and adherence.
Why this condition is needed: Needed to avoid converting AGE mass into SAC marker content or substituting raw garlic, black garlic or isolated SAC.
Application exceptions: SAC 1.2 mg is the marker content of this formulation; it does not establish isolated-SAC efficacy or equivalence to other products.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N06 · Which measurement, time point and analysis does the 12-week office-SBP value represent?

Current findings: The evidence endpoint is 12-week office SBP; the Korean/English reader answers report an adjusted between-group contrast of −5.0±2.1 mmHg (P=.016).
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.
Reason for missing information: Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.
Required materials and conditions: Office systolic pressure in mmHg, the adjusted between-group change from baseline at 12 weeks and its analysis definition.
Materials to obtain first: 12-week result table, definitions of baseline/final/change values, measurement frequency/equipment and adjustment variables.
Further research: Material needed: 12-week result table, definitions of baseline/final/change values, measurement frequency/equipment and adjustment variables. This records needed materials; no new research was executed.
Remaining uncertainty: Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.
Conditions for verification: Attribute the value to the adjusted 12-week office-SBP group contrast and retain unverified measurement contract, variance type and model details.
Why this condition is needed: Needed to avoid treating within-group reductions, 24-hour pressure, DBP or central pressure as the same effect.
Application exceptions: Generic English principal-endpoint wording must not be promoted to verification of the registered primary endpoint.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N07 · Which denominators do 88 completers and 84 in the adjusted analysis represent?

Current findings: The original count is 88 completers and 84 in the adjusted analysis; the reader answer notes limitations from protocol-related exclusions.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.
Reason for missing information: Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.
Required materials and conditions: Total randomized and allocated/completed/analyzed counts by group, reasons for exclusion/missingness and uncertainty intervals.
Materials to obtain first: CONSORT flowchart, analysis tables by group, reasons for protocol exclusions, missing-data handling and CIs.
Further research: Material needed: CONSORT flowchart, analysis tables by group, reasons for protocol exclusions, missing-data handling and CIs. This records needed materials; no new research was executed.
Remaining uncertainty: Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.
Conditions for verification: Retain 88 completers and 84 in the adjusted analysis separately; show unverified group, allocation and loss information.
Why this condition is needed: Needed to avoid substituting completed/analyzed denominators for randomized, ITT or group-specific denominators.
Application exceptions: Do not add 88 and 84 or assume 44/42 per group or a unique-participant total.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N08 · Are DBP, central pressure and responder signals kept separate from the main SBP result?

Current findings: The Korean/English explanation states that larger responder reductions, DBP and central pressure were not merged into the main claim.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.
Reason for missing information: The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.
Required materials and conditions: Boundaries between the overall adjusted SBP estimate and secondary/subgroup results, including contrary or no-difference information.
Materials to obtain first: Complete results by endpoint, subgroup definitions/denominators, prespecified plans and interactions.
Further research: Material needed: Complete results by endpoint, subgroup definitions/denominators, prespecified plans and interactions. This records needed materials; no new research was executed.
Remaining uncertainty: The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.
Conditions for verification: Keep other endpoints and responder values separate from the main SBP estimate; retain unverified specific results and hierarchy.
Why this condition is needed: Needed to prevent favorable subgroup values from replacing the overall main estimate.
Application exceptions: Mention of other results in the original explanation must not become a new conclusion of no DBP effect or conflicting data.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N09 · What are the original review date and the scope of this reading?

Current findings: The retained review date is 2026-09-08 and the correction date is 2026-09-14; this preparation converts an actual reading of the current retained material.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.
Reason for missing information: Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.
Required materials and conditions: The retained review date 2026-09-08, correction date, current reading date, retained inputs, search cutoff and individual access dates.
Materials to obtain first: Historical search strategy/cutoff, material-specific access history and later publication/correction lists.
Further research: Material needed: Historical search strategy/cutoff, material-specific access history and later publication/correction lists. This records needed materials; no new research was executed.
Remaining uncertainty: Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.
Conditions for verification: Separate original dates from current local checks and limit statements of absence to the retained material.
Why this condition is needed: Needed to avoid turning the retained manuscript-review date into a current clinical-search cutoff or current full-text access date.
Application exceptions: 0 new searches must not be described as 0 studies or no subsequent material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N10 · How far was the wording about a blood-pressure meta-analysis retracted in 2026 verified?

Current findings: The Korean/English research description contains a historical statement about excluding a blood-pressure meta-analysis retracted in 2026, but the evidence/citation entries do not identify it.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.
Reason for missing information: The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.
Required materials and conditions: Publication ID, retraction notice, affected results and original exclusion decision for that meta-analysis.
Materials to obtain first: Exact DOI/PMID, retraction notice, original report and documented exclusion reason.
Further research: Material needed: Exact DOI/PMID, retraction notice, original report and documented exclusion reason. This records needed materials; no new research was executed.
Remaining uncertainty: The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.
Conditions for verification: Quote only the historical exclusion statement; leave current verification of the publication and retraction notice unverified.
Why this condition is needed: Needed to avoid promoting an unidentified historical exclusion statement into a currently verified retraction or new report.
Application exceptions: Do not add an unidentified meta-analysis as S02, an independent trial or a main SBP result.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N11 · Do company funding, capsule provision and a no-involvement declaration mean the same thing?

Current findings: The retained funding entry states Wakunaga of America research funding and capsule provision, with a declaration of no involvement in design/analysis; the historical independence axis is I0.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.
Reason for missing information: The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.
Required materials and conditions: Wakunaga of America funding/product provision, roles in design/analysis, author roles and declared conflicts.
Materials to obtain first: Original funding/COI statements, product-support information, author employment/institutions and analysis-responsibility documents.
Further research: Material needed: Original funding/COI statements, product-support information, author employment/institutions and analysis-responsibility documents. This records needed materials; no new research was executed.
Remaining uncertainty: The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.
Conditions for verification: Retain research funding, capsule provision and the no-involvement declaration separately; show unverified COI and institutional/author roles.
Why this condition is needed: Needed to avoid converting company support into independent funding or the no-involvement declaration alone into absence of bias.
Application exceptions: Do not delete the original effect solely because support exists or newly certify the support declaration.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N12 · Is implementation of the double-blind randomized placebo-controlled design verified?

Current findings: The retained Korean/English design fields describe a randomized, double-blind, placebo-controlled study.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.
Reason for missing information: Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.
Required materials and conditions: Allocation method, concealment, baseline balance, who was blinded, maintenance of blinding and actual design.
Materials to obtain first: Methods section, allocation/concealment procedures, baseline table and blinding assessment.
Further research: Material needed: Methods section, allocation/concealment procedures, baseline table and blinding assessment. This records needed materials; no new research was executed.
Remaining uncertainty: Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.
Conditions for verification: Distinguish the retained design description from unverified implementation material.
Why this condition is needed: A design label alone cannot establish that allocation or confounding issues were resolved.
Application exceptions: Do not fill unverified parallel/crossover/cluster design details with an arbitrary not-applicable status or a definite design.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N13 · Were concomitant antihypertensives, changes and adherence mixed with the AGE contribution?

Current findings: The population/intervention fields and central explanation describe AGE added to stable existing treatment; the Korean population also includes untreated adults.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.
Reason for missing information: Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.
Required materials and conditions: Group composition on existing care/no treatment, drug types/doses, changes/rescue treatment, AGE adherence and analysis handling.
Materials to obtain first: Medication lists/changes by group, adherence, rescue treatment and deviation analyses.
Further research: Material needed: Medication lists/changes by group, adherence, rescue treatment and deviation analyses. This records needed materials; no new research was executed.
Remaining uncertainty: Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.
Conditions for verification: Separate the stable-care plan from verified levels of actual changes and adherence by group.
Why this condition is needed: Needed to avoid attributing contributions from changes in other medication to the AGE 1.2 g effect.
Application exceptions: Do not describe an add-on trial as antihypertensive replacement or assume that every participant took medication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N14 · Can office-SBP measurement error and assessor blinding be assessed?

Current findings: The retained material provides only 12-week office SBP and a double-blind design label.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.
Reason for missing information: Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.
Required materials and conditions: Equipment, posture, rest, repeated measurements, timing, assessor blinding and differences between groups.
Materials to obtain first: Blood-pressure measurement protocol, assessor/equipment validation and original measurement tables.
Further research: Material needed: Blood-pressure measurement protocol, assessor/equipment validation and original measurement tables. This records needed materials; no new research was executed.
Remaining uncertainty: Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.
Conditions for verification: Describe actual SBP procedures and conditions by group only to the level verified.
Why this condition is needed: A double-blind design label does not automatically establish standardized pressure measurement or verified assessor blinding.
Application exceptions: Do not assume absence of measurement bias because the outcome is a numerical measurement.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N15 · Which effect does the adjusted analysis of 84 participants estimate?

Current findings: The reader answer reports an adjusted group contrast and limitations from protocol-related exclusions; the evidence count reports 84 in the adjusted analysis.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.
Reason for missing information: Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.
Required materials and conditions: Effect of assignment/adherence, ITT/PP, exclusion criteria, adjustment variables and definition of the group contrast.
Materials to obtain first: SAP, analysis-set definitions, exclusion reasons, adjustment model and ITT/sensitivity tables.
Further research: Material needed: SAP, analysis-set definitions, exclusion reasons, adjustment model and ITT/sensitivity tables. This records needed materials; no new research was executed.
Remaining uncertainty: Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.
Conditions for verification: Retain the adjusted contrast and 84 analyzed as originally worded; show unverified analysis-set and model details.
Why this condition is needed: Needed to avoid promoting 88 completers and the estimate in 84 after protocol exclusions into full ITT.
Application exceptions: Mention of protocol exclusions alone must not newly establish a complete PP model or post hoc selection.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N16 · Is there material to interpret the precision of −5.0±2.1 mmHg and P=.016?

Current findings: The retained result is a between-group −5.0±2.1 mmHg, P=.016; the Korean/English reader answers call it an adjusted contrast.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.
Reason for missing information: The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.
Required materials and conditions: Between-group estimate, whether ±2.1 is SD/SE/CI, confidence interval, group-specific changes and justified clinical importance.
Materials to obtain first: Original result table, variance definition, CI, changes by group and basis for clinical importance.
Further research: Material needed: Original result table, variance definition, CI, changes by group and basis for clinical importance. This records needed materials; no new research was executed.
Remaining uncertainty: The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.
Conditions for verification: Retain the original effect, P value and units; explain unverified uncertainty bounds and importance.
Why this condition is needed: The P value and sample size alone cannot establish sufficient effect magnitude, precision or clinical meaning.
Application exceptions: Do not read ± as a CI or calculate a new confidence interval, values by group, minimum sample size or importance threshold.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N17 · Do the prespecified endpoint/analysis plan and reporting agree for 12-week SBP?

Current findings: The retained registration field says not verified, while the research description contains a historical statement about comparing the AGE at Heart paper and registration.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.
Reason for missing information: Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.
Required materials and conditions: Original trial registration, protocol, SAP, endpoint hierarchy and analysis/time-point changes.
Materials to obtain first: Exact registration identifier, protocol/SAP versions and a results/change comparison table.
Further research: Material needed: Exact registration identifier, protocol/SAP versions and a results/change comparison table. This records needed materials; no new research was executed.
Remaining uncertainty: Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.
Conditions for verification: Retain both the original registration field and historical narrative; show unverified comparison against actual prespecified plans.
Why this condition is needed: Needed to avoid inheriting a historical paper/registration comparison narrative as current reading of the registry or SAP.
Application exceptions: A not-verified registration field does not establish non-registration or selective reporting.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N18 · Is independent replication verified for the same formulation, dose, population and 12-week SBP?

Current findings: The counterview says the same group's dose study and another aged-black-garlic product do not establish formulation- and funding-independent replication.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.
Reason for missing information: The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.
Required materials and conditions: Unique study families, independence of formulation/funding/team and trial-specific estimates.
Materials to obtain first: Bibliography/registration, exact formulations, institutions/funding and individual results for the earlier study and other products.
Further research: Material needed: Bibliography/registration, exact formulations, institutions/funding and individual results for the earlier study and other products. This records needed materials; no new research was executed.
Remaining uncertainty: The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.
Conditions for verification: Retain the distinction between S01 and background wording; leave independent replication and unique study counts unverified.
Why this condition is needed: Needed to avoid counting the same-group dose study and another black-garlic product as independent replication of the matched product.
Application exceptions: Do not automatically inherit the historical R1/I0 axes as new condition statuses or new replication counts.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N19 · Can AGE 1.2 g and SAC 1.2 mg be interpreted as the optimal dose?

Current findings: The retained selected amount is AGE 1.2 g/SAC 1.2 mg/day in 2 capsules; the same group's earlier dose study appears only in background wording.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.
Reason for missing information: The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.
Required materials and conditions: Direct dose comparisons, product specifications, estimates/harms by dose and prespecified analysis.
Materials to obtain first: Exact bibliography of the earlier dose trial, group counts by dose, effects/CIs and support information.
Further research: Material needed: Exact bibliography of the earlier dose trial, group counts by dose, effects/CIs and support information. This records needed materials; no new research was executed.
Remaining uncertainty: The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.
Conditions for verification: Distinguish the selected dose from unverified optimal-dose or higher/lower-dose effects.
Why this condition is needed: Needed to avoid treating mention of the same group's earlier dose study as certification of an optimal dose.
Application exceptions: Do not make all dose trials mandatory for the narrow 12-week SBP question at the exact single dose.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N20 · Does this answer persistence, effects after stopping or longer-term pressure beyond 12 weeks?

Current findings: The retained duration is 12 weeks of treatment and 12 weeks of follow-up; the scope note also limits the claim to 12-week SBP.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.
Reason for missing information: Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.
Required materials and conditions: Long-term/post-discontinuation follow-up, persistence in the same population/intervention/comparison and medication changes/adherence.
Materials to obtain first: Long-term/post-discontinuation results, treatment changes by group, missingness and adherence.
Further research: Material needed: Long-term/post-discontinuation results, treatment changes by group, missingness and adherence. This records needed materials; no new research was executed.
Remaining uncertainty: Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.
Conditions for verification: Separate the direct 12-week scope from unverified later persistence.
Why this condition is needed: Needed to avoid extending 12-week treatment/follow-up into long-term persistence.
Application exceptions: Do not make long-term trials automatically mandatory for the narrow 12-week SBP result.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N21 · Can a larger decrease in responders be read as the overall effect?

Current findings: The Korean/English explanation records that larger reductions in the responder subgroup were not merged into the main claim.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.
Reason for missing information: Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.
Required materials and conditions: Responder definition, prespecified plan, subgroup count, group contrast/CI and interaction.
Materials to obtain first: Responder criteria, SAP, subgroup denominators/results and effect-modification tests.
Further research: Material needed: Responder criteria, SAP, subgroup denominators/results and effect-modification tests. This records needed materials; no new research was executed.
Remaining uncertainty: Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.
Conditions for verification: Distinguish overall SBP from responder signals; show unverified definitions, plans and denominators.
Why this condition is needed: Needed to prevent larger reductions in selected responders from replacing the overall adjusted estimate.
Application exceptions: Do not require every subgroup validation for the present main question or create a new subgroup-efficacy sheet.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N22 · Does the office-SBP difference directly answer cardiovascular-event prevention?

Current findings: The retained advertising explanation says the result cannot be extended to all garlic products or cardiovascular-event prevention.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.
Reason for missing information: The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.
Required materials and conditions: Boundary between SBP results and myocardial infarction, stroke, death or quality of life.
Materials to obtain first: Population, formulation, follow-up, event counts/denominators and analysis in separate direct event studies.
Further research: Material needed: Population, formulation, follow-up, event counts/denominators and analysis in separate direct event studies. This records needed materials; no new research was executed.
Remaining uncertainty: The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.
Conditions for verification: Maintain the current SBP scope and show unverified direct event material.
Why this condition is needed: Needed to avoid automatically extending a pressure difference into prevention of clinical events or replacement of treatment.
Application exceptions: Do not make event trials mandatory for a question about the numerical pressure change itself.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N23 · At what level is safety for the same AGE exposure reported?

Current findings: The historical safety label is Caution, with cautions about hypotension/dizziness when combined with antihypertensives and perioperative or anticoagulant/antiplatelet use.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.
Reason for missing information: The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.
Required materials and conditions: Adverse events/discontinuations, collection, denominators by group and observation time for the same formulation over 12 weeks.
Materials to obtain first: Trial-specific AE/SAE and discontinuation tables, collection methods and exposure denominators by group.
Further research: Material needed: Trial-specific AE/SAE and discontinuation tables, collection methods and exposure denominators by group. This records needed materials; no new research was executed.
Remaining uncertainty: The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.
Conditions for verification: Distinguish the original cautions from direct trial harm tables; retain unverified collection and frequency.
Why this condition is needed: Needed to avoid converting the original caution into observed trial harms or confirmed safety.
Application exceptions: Do not delete the retained SBP result because harms remain unverified.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N24 · Are event definitions and collection recorded for hypotension, dizziness or bleeding?

Current findings: The retained safety details contain cautions but no trial event table.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.
Reason for missing information: Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.
Required materials and conditions: Trial event definitions, severity, systematic collection, discontinuations and ascertainment methods.
Materials to obtain first: AE definitions, collection forms, severity/discontinuation records and assessment tables.
Further research: Material needed: AE definitions, collection forms, severity/discontinuation records and assessment tables. This records needed materials; no new research was executed.
Remaining uncertainty: Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.
Conditions for verification: Separate original cautions from the existence or unverified status of event-collection material.
Why this condition is needed: Needed to avoid converting a general caution into a complete count of diagnosed events.
Application exceptions: Monitoring/consultation wording in the original caution alone must not establish actual events or causality.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N25 · Is the timing of the cautioned events relative to AGE exposure recorded?

Current findings: The efficacy duration is 12 weeks, but the retained material provides no event-specific harm timelines.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.
Reason for missing information: Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.
Required materials and conditions: Start/stop of use, event onset/recovery, re-exposure and latency.
Materials to obtain first: Individual harm timelines, discontinuation/recovery/re-exposure and exposure-duration records.
Further research: Material needed: Individual harm timelines, discontinuation/recovery/re-exposure and exposure-duration records. This records needed materials; no new research was executed.
Remaining uncertainty: Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.
Conditions for verification: Show the 12-week efficacy period separately from harm-specific timing information.
Why this condition is needed: The 12-week trial duration alone cannot establish temporal order or causality for harms.
Application exceptions: Do not infer improvement after discontinuation, re-exposure or individual events when absent.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N26 · Was the placebo comparison also used for an actual harm estimate?

Current findings: The original comparator is matching placebo plus existing blood-pressure care; the retained material contains no comparative harm results.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.
Reason for missing information: Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.
Required materials and conditions: AGE/placebo adverse events, background treatment and comparative estimates.
Materials to obtain first: AE results and denominators by group, harm estimates/intervals and concomitant care.
Further research: Material needed: AE results and denominators by group, harm estimates/intervals and concomitant care. This records needed materials; no new research was executed.
Remaining uncertainty: Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.
Conditions for verification: Separate the placebo contract for SBP from an unverified actual harm-comparison table.
Why this condition is needed: Needed to avoid turning the existence of an efficacy placebo into verification of a between-group harm comparison.
Application exceptions: Do not fill cautions lacking a comparison with extrapolated incidence or risk ratios.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N27 · Are exposure and event denominators available for harm frequency?

Current findings: The current counts of 88 completers and 84 in the adjusted analysis concern efficacy; harm denominators are not specified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Harm-exposure denominators, event counts and time-specific estimates remain unverified.
Reason for missing information: Harm-exposure denominators, event counts and time-specific estimates remain unverified.
Required materials and conditions: Exposed participants by group, people/events, observation time and recruitment/reporting system.
Materials to obtain first: AE exposure denominators by group, people/event counts and follow-up time.
Further research: Material needed: AE exposure denominators by group, people/event counts and follow-up time. This records needed materials; no new research was executed.
Remaining uncertainty: Harm-exposure denominators, event counts and time-specific estimates remain unverified.
Conditions for verification: Report frequency only for reported values linked to the relevant harm denominator and time.
Why this condition is needed: Needed to avoid turning 88 completers/84 in the efficacy analysis into denominators for harm incidence.
Application exceptions: Do not use efficacy denominators to assert 0 events or calculate incidence/risk differences.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N28 · Is there material to attribute hypotension/dizziness during combined antihypertensive and AGE use?

Current findings: The original safety details advise monitoring for hypotension and dizziness with existing antihypertensives.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.
Reason for missing information: The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.
Required materials and conditions: Medication types/doses, actual AGE exposure, baseline pressure, concurrent changes and event-specific alternatives.
Materials to obtain first: Medication changes by group, symptom timing, baseline values and harms by concomitant treatment.
Further research: Material needed: Medication changes by group, symptom timing, baseline values and harms by concomitant treatment. This records needed materials; no new research was executed.
Remaining uncertainty: The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.
Conditions for verification: Retain the original hypotension/dizziness caution; show unverified background medication and alternative event information.
Why this condition is needed: Needed to avoid attributing medication or baseline-factor contributions solely to AGE causality.
Application exceptions: Do not describe the original combined-use caution as an observed trial interaction or an instruction to replace medication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N29 · What direct material supports cautions about surgery or anticoagulant/antiplatelet use?

Current findings: The original safety details contain cautions about perioperative or anticoagulant/antiplatelet use.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.
Reason for missing information: Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.
Required materials and conditions: Perioperative exposure, concomitant medication, bleeding events and alternative causes for the same formulation/dose.
Materials to obtain first: Surgery timing, concomitant medication, exposure, bleeding definitions/denominators and original reports for the same formulation.
Further research: Material needed: Surgery timing, concomitant medication, exposure, bleeding definitions/denominators and original reports for the same formulation. This records needed materials; no new research was executed.
Remaining uncertainty: Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.
Conditions for verification: Distinguish the original perioperative/combined-use caution from unverified direct trial material.
Why this condition is needed: Needed to avoid certifying a general garlic caution as bleeding causality or incidence in this trial.
Application exceptions: Retain the caution without creating personal discontinuation or medical instructions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N30 · Can the relationship between follow-up loss, protocol exclusions and missing harms be verified?

Current findings: The protocol-exclusion limitation in the reader answer and the counts of 88 completers/84 in the adjusted analysis are retained.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.
Reason for missing information: Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.
Required materials and conditions: Recruitment/reporting, exclusions/losses by group, stopping harm collection and scope of complete event disclosure.
Materials to obtain first: Reasons for losses/exclusions by group, AE-related discontinuations and completeness of follow-up/reporting.
Further research: Material needed: Reasons for losses/exclusions by group, AE-related discontinuations and completeness of follow-up/reporting. This records needed materials; no new research was executed.
Remaining uncertainty: Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.
Conditions for verification: Separate the original exclusion limitation from direct information on missing harm data.
Why this condition is needed: Needed to avoid assuming that the difference between 84 analyzed/88 completed reflects harm-related losses or no events.
Application exceptions: Do not reclassify efficacy-analysis exclusions as actual harm-related dropouts.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N31 · Were the cautioned events repeated in independent material?

Current findings: The retained evidence/citation entries identify 1 report; there is no bibliography for separate harm reports or regulatory material.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.
Reason for missing information: Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.
Required materials and conditions: Unique harm reports/studies, exact formulation/dose, events and re-citation/regulatory relationships.
Materials to obtain first: Identified direct harm reports, original registration/regulatory material and a re-citation family map.
Further research: Material needed: Identified direct harm reports, original registration/regulatory material and a re-citation family map. This records needed materials; no new research was executed.
Remaining uncertainty: Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.
Conditions for verification: Distinguish S01 cautions from unverified independent harm families.
Why this condition is needed: Needed to avoid counting general cautions, the same report or another black-garlic product as repeated independent signals.
Application exceptions: Absence of original harm reports in the retained material must not become a claim of 0 harms worldwide.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N32 · Is safety established for rare or long-term harms and vulnerable groups beyond 12 weeks?

Current findings: The current exposure period is 12 weeks, and the original caution mentions combined use and surgery.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.
Reason for missing information: The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.
Required materials and conditions: Long-term/rare events, baseline risks, vulnerable groups, concomitant/perioperative exposures and follow-up.
Materials to obtain first: Direct material on long-term exposure/rare events and older adults, underlying disease or concomitant/perioperative use.
Further research: Material needed: Direct material on long-term exposure/rare events and older adults, underlying disease or concomitant/perioperative use. This records needed materials; no new research was executed.
Remaining uncertainty: The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.
Conditions for verification: Distinguish the present duration/population from unverified long-term or special-exposure scopes.
Why this condition is needed: Needed to avoid extending a small 12-week efficacy record into overall safety.
Application exceptions: Do not make all vulnerable-group/rare-harm material mandatory for the narrow SBP-efficacy question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01

N33 · Does the original caution concern signals, comparative risk or causality?

Current findings: The original Caution label, C50 and all axes are retained historical values; direct information on harm occurrence or causality was not verified.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.
Why unverified: The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.
Reason for missing information: The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.
Required materials and conditions: Direct design, events, denominators, timing, comparison, alternatives and the scope of currently possible statements.
Materials to obtain first: An exact harm question, original event tables and direct comparative/timing/alternative-explanation material.
Further research: Material needed: An exact harm question, original event tables and direct comparative/timing/alternative-explanation material. This records needed materials; no new research was executed.
Remaining uncertainty: The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.
Conditions for verification: Retain original C50/Caution/axes only as historical quotations and distinguish unverified direct harms.
Why this condition is needed: Needed to avoid turning the original caution or positive efficacy result into a safety grade, risk magnitude or established causality.
Application exceptions: Do not create medical dosing instructions or new efficacy/safety scores or grades.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S01