# Oral single-ingredient berberine × Reduction of LDL-C in adults with dyslipidemia

Verdict 3068 · Evidence Check

Stored-material review date: 2026-10-05  
Original evidence review date: 2026-09-08  
Review-criteria version: 1.1  
Public page/material preparation date: 2026-10-27

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Adults with dyslipidemia, mainly at low cardiovascular risk. Sex, diagnosis, baseline LDL-C, eligibility and actual analysis counts require report-specific verification.
- Ingredient, formulation and route: Oral single-ingredient berberine tablets/capsules. Botanical sources differ or are partly unknown. Mixed nutraceuticals, Berberis extracts, other derivatives and topical products are not interchangeable.
- Dose: The nominal range is mainly 900~1,500 mg/day. Trial-specific products, salt forms, purity, dosing schedules, actual intake and adherence remain unverified. This is not presented as an optimal or safe dose.
- Comparator: Versus placebo. Actual comparison of common treatment, including arm-specific lipid medicines, diet, activity, rescue treatment and adherence, remains unverified.
- Measured outcome: The absolute between-arm difference in treatment-end LDL-C. Distinguish mmol/L MD, SD-scale estimates and direction-only reports. TG, HDL, apoB and cardiovascular events are different questions.
- Duration: The overall nominal range is 4~24 weeks. Retain S02/S03 week 12 and S04 at 3 months separately, without arbitrary conversion or extension to long-term persistence.
- Questions outside this scope: Original C, 50 points, Warning and B/S/R0/I2/EX/B2/CX are retained. Table statuses are not new efficacy scores or clinical certification.; Distinguish S01 LDL-C 14 RCTs/1,447 participants from the whole review of 18 RCTs/1,788 participants. Pooled MD −0.46 mmol/L, 95% CI −0.62~−0.30 is not a guaranteed effect for a specific product or person.; S02 data from 84 men were reused as stored samples in S03. Distinguish S03 recruitment of 100 women; do not count the reports as two independent LDL confirmations or newly add participant totals.; Retain the SD scale for S03 women’s LDL and the primary apoB/secondary LDL hierarchy. Do not convert against male mmol/L results or calculate a new sex interaction.; Statin replacement, cardiovascular-event prevention, optimal dose, long-term persistence and personal safety are not established. Retain original gastrointestinal and pregnancy/lactation/infant/CYP-comedication cautions; actual harm frequencies, denominators and causality remain unverified.; Retain the mismatch between the English evidence-table correction’s specific-replacement description and current generic wording. This is separate from clinical-result conflict; the new reader translation does not establish the historical correction event.

## Checklist items

### N01 · Does the table address oral single-ingredient berberine versus placebo for treatment-end LDL-C?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The selected question compares oral single-ingredient berberine with placebo for treatment-end LDL-C in adults with dyslipidemia. Products, durations and populations differ across reports and are not combined into a guaranteed effect.
- Why unverified: The original question and table boundary are verified. This status verifies question identity and does not establish a new efficacy judgment.
- Reason for missing information: The original question and table boundary are verified. This status verifies question identity and does not establish a new efficacy judgment.
- Required materials and conditions: The current claim, claim conditions in both languages and original locations for the inclusion/exclusion boundary.
- Materials to obtain first: The current claim, claim conditions in both languages and original locations for the inclusion/exclusion boundary.
- Further research: Future comparative trials should prespecify the ingredient, formulation, population, placebo and treatment-end LDL-C measure.
- Conditions for verification: Link the original claim to the population, single ingredient, oral route, placebo and treatment-end LDL-C scope; exclude other lipid and event questions.
- Why this condition is needed: This boundary condition distinguishes the whole ingredient page from the narrow comparison question.
- Application exceptions: TG, HDL, apoB, cardiovascular events, statin replacement, other derivatives and combinations do not substitute for this LDL-C question.
- Remaining uncertainty: This boundary condition distinguishes the whole ingredient page from the narrow comparison question.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N02 · Can actual dyslipidemia diagnoses and eligibility criteria by sex and risk group be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The original claim conditions mainly concern adults with dyslipidemia at low cardiovascular risk. S02 lists 84 Chinese men, S03 lists 100 women and 84 existing male participants, and S04 lists 144 low-risk people enrolled; detailed eligibility criteria are absent.
- Why unverified: Population labels and nominal composition are available, but actual diagnostic criteria, baseline distributions and recruitment settings remain unverified.
- Reason for missing information: Population labels and nominal composition are available, but actual diagnostic criteria, baseline distributions and recruitment settings remain unverified.
- Required materials and conditions: Trial-specific eligibility criteria and baseline tables, sex composition and dyslipidemia definitions.
- Materials to obtain first: Trial-specific eligibility criteria and baseline tables, sex composition and dyslipidemia definitions.
- Further research: Use consistent diagnostic criteria in placebo-controlled trials and report baseline LDL-C, eligibility by sex/risk group and recruitment flow.
- Conditions for verification: Link each trial's diagnosis, baseline LDL-C, age, sex, cardiovascular risk and inclusion/exclusion criteria to the relevant result population.
- Why this condition is needed: Similar population labels do not establish representativeness or directness.
- Application exceptions: Do not transfer results from another sex, high-risk populations or people with normal lipids to the same target effect.
- Remaining uncertainty: Similar population labels do not establish representativeness or directness.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N03 · Can each trial's berberine ingredient, salt form, content, formulation and absence of other active ingredients be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The scope includes single-ingredient tablets/capsules and reportedly excludes combinations and Berberis extracts. Botanical sources differ or are partly unknown; salt form, purity and actual content for each trial are not provided.
- Why unverified: The single-ingredient inclusion scope is known, but product equivalence, quality and actual ingredient content cannot be verified.
- Reason for missing information: The single-ingredient inclusion scope is known, but product equivalence, quality and actual ingredient content cannot be verified.
- Required materials and conditions: Product names, ingredient lists, salt/purity, standardization and trial-specific formulations.
- Materials to obtain first: Product names, ingredient lists, salt/purity, standardization and trial-specific formulations.
- Further research: Design placebo-controlled trials of the same single-active-ingredient product, recording batch-specific content, purity, impurities and administered formulation.
- Conditions for verification: Verify product-specific ingredient, purity, content and formulation; distinguish mixed nutraceuticals, Berberis extracts and derivatives.
- Why this condition is needed: Distinguish single-ingredient effects from contributions of other products or combined interventions.
- Application exceptions: Do not interchange berberine hydrochloride, dihydroberberine, mixed formulations, botanical extracts and topical products.
- Remaining uncertainty: Distinguish single-ingredient effects from contributions of other products or combined interventions.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N04 · Can nominal doses, dosing frequency and actual intake in each trial be linked to LDL-C results?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The original claim conditions state mainly 900~1,500 mg/day. Individual dosing schedules and actual intake in S01's included trials and S02–S04 are unverified in this retained summary.
- Why unverified: A dose range for the overall article is available, but the product and exact exposure behind each result remain unverified.
- Reason for missing information: A dose range for the overall article is available, but the product and exact exposure behind each result remain unverified.
- Required materials and conditions: Trial-specific dosing schedules, nominal/actual content and adherence records.
- Materials to obtain first: Trial-specific dosing schedules, nominal/actual content and adherence records.
- Further research: Record actual dose and adherence for the same product. Add a separate randomized dose contrast only when asking about dose effects.
- Conditions for verification: Link trial-specific mg/day, divided doses, formulation and adherence-related actual exposure to the corresponding result time.
- Why this condition is needed: Distinguish nominal ranges from actual exposure, and the main effect from dose-extension claims.
- Application exceptions: Do not declare this range an optimal dose, safe dose or identical dose across all trials.
- Remaining uncertainty: Distinguish nominal ranges from actual exposure, and the main effect from dose-extension claims.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N05 · Can arm-specific lipid medicines, diet, lifestyle, rescue treatment and adherence be verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained text describes a single ingredient versus placebo but provides no arm-specific lipid medicines, diet/activity, rescue treatment or actual adherence information. Statin-replacement claims are excluded.
- Why unverified: A single-product label and placebo design do not verify identical background treatment or absence of confounding.
- Reason for missing information: A single-product label and placebo design do not verify identical background treatment or absence of confounding.
- Required materials and conditions: Trial-specific concomitant lipid medicines, diet/activity plans, rescue treatment, adherence and arm-specific changes.
- Materials to obtain first: Trial-specific concomitant lipid medicines, diet/activity plans, rescue treatment, adherence and arm-specific changes.
- Further research: Define and maintain common treatment; collect arm-specific changes, adherence and rescue treatment to distinguish assignment effects from treatment deviations.
- Conditions for verification: Verify common treatments, changes and deviations in both arms; explain how other intervention differences may enter the LDL-C comparison.
- Why this condition is needed: Avoid attributing effects of other treatment changes solely to berberine.
- Application exceptions: Do not require absence of every concomitant medicine; verify actual changes and handling appropriate to the common background and effect of interest.
- Remaining uncertainty: Avoid attributing effects of other treatment changes solely to berberine.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N06 · Can treatment-end values, changes, adjustment methods and LDL-C units be verified for each result?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The claim conditions specify an absolute between-arm difference in treatment-end LDL-C. S01/S02 use mmol/L MD, S03 women use an SD scale, and S04 supplies only a reduction direction; final-value/change and adjustment details are absent.
- Why unverified: The endpoint and some units are specified, but identical analysis definitions are unverified, so the results cannot be combined into one number.
- Reason for missing information: The endpoint and some units are specified, but identical analysis definitions are unverified, so the results cannot be combined into one number.
- Required materials and conditions: Trial-specific result tables, baseline/end values, change definitions, adjustment models and unit descriptions.
- Materials to obtain first: Trial-specific result tables, baseline/end values, change definitions, adjustment models and unit descriptions.
- Further research: Report baseline, end and change values in mmol/L with a prespecified between-arm model; report SD-scale results separately.
- Conditions for verification: Assign estimates to the treatment-end absolute between-arm-difference question; distinguish mmol/L from SD scales and final values from changes.
- Why this condition is needed: Avoid presenting numbers with different measures or analysis definitions as the same effect.
- Application exceptions: Do not convert TG, HDL, apoB or standardized SD results into an absolute LDL-C difference in original units.
- Remaining uncertainty: Avoid presenting numbers with different measures or analysis definitions as the same effect.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N07 · Can the exact end time and observation window for each LDL-C result be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The overall range is 4~24 weeks. S02/S03 record week 12 LDL-C and S04 records 3-month LDL-C. S01's trial-specific end times and result-selection rules are not provided.
- Why unverified: Some nominal report times are verified, but actual blood-sampling windows and selection of pooled times remain unresolved.
- Reason for missing information: Some nominal report times are verified, but actual blood-sampling windows and selection of pooled times remain unresolved.
- Required materials and conditions: Trial-specific dosing/blood-sampling times, analysis windows and meta-analysis end-time selection rules.
- Materials to obtain first: Trial-specific dosing/blood-sampling times, analysis windows and meta-analysis end-time selection rules.
- Further research: Prespecify blood-sampling windows and target times, report all available times and investigate persistence with separate follow-up.
- Conditions for verification: Link included-trial times and the 12-week/3-month records to their own results without converting them into an identical duration.
- Why this condition is needed: Avoid hiding duration differences or turning short-term end values into persistence effects.
- Application exceptions: Do not arbitrarily convert 3 months into 12 weeks or extend short-term data to long-term persistence.
- Remaining uncertainty: Avoid hiding duration differences or turning short-term end values into persistence effects.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N08 · Are each RCT's design labels and actual sequence generation, concealment and baseline balance verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S01 pools placebo-controlled RCTs; S02/S04 are labeled double-blind randomized placebo trials; S03 is labeled a randomized placebo trial plus stored-sample analysis. Actual sequence generation, concealment and baseline-balance data are absent.
- Why unverified: Design names are available, but the allocation process and arm-specific baseline balance for the selected LDL-C result remain unverified.
- Reason for missing information: Design names are available, but the allocation process and arm-specific baseline balance for the selected LDL-C result remain unverified.
- Required materials and conditions: Original-trial protocols, allocation methods, concealment procedures and baseline tables.
- Materials to obtain first: Original-trial protocols, allocation methods, concealment procedures and baseline tables.
- Further research: Conduct placebo-controlled trials reporting sequence generation, concealment and balance in baseline LDL-C and associated factors.
- Conditions for verification: Verify actual sequence generation, concealment and baseline tables separately from retained placebo-RCT/double-blind labels. Design titles alone do not establish adequate allocation.
- Why this condition is needed: Distinguish design titles from the actual allocation conditions for causal comparison.
- Application exceptions: Do not say an RCT title establishes absence of bias or completion of a formal RoB assessment.
- Remaining uncertainty: Distinguish design titles from the actual allocation conditions for causal comparison.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N09 · Can LDL-C assay methods, specimen conditions and assessor blinding be verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained article contains LDL-C results and double-blind labels but no specific assay methods, fasting conditions, laboratory quality-control or assessor-blinding data.
- Why unverified: Actual measurement conditions cannot be read from this summary. This does not establish nonreporting in the full original papers.
- Reason for missing information: Actual measurement conditions cannot be read from this summary. This does not establish nonreporting in the full original papers.
- Required materials and conditions: Specimen collection, fasting time, LDL-C assay/calculation methods, quality control and analyst blinding.
- Materials to obtain first: Specimen collection, fasting time, LDL-C assay/calculation methods, quality control and analyst blinding.
- Further research: Apply consistent assays and prespecified blood-sampling/fasting windows; report laboratory quality control and assessor blinding.
- Conditions for verification: Verify sampling/fasting conditions, direct or calculated LDL-C assays, laboratory/assessment procedures and differences between arms.
- Why this condition is needed: Distinguish differences in assay/collection conditions from actual LDL-C differences.
- Application exceptions: An objective lipid test alone does not resolve arm-specific measurement differences or specimen conditions.
- Remaining uncertainty: Distinguish differences in assay/collection conditions from actual LDL-C differences.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N10 · What are S01's reported LDL-C-specific and whole-review denominators?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S01 specifies 14 LDL-C RCTs/1,447 participants and 18 RCTs/1,788 participants overall. These are the retained review's endpoint-specific totals, not current certification of unique trials or participants.
- Why unverified: Attribution of the two totals is directly specified. Completeness of trial-specific analysis denominators is examined separately in the next condition.
- Reason for missing information: Attribution of the two totals is directly specified. Completeness of trial-specific analysis denominators is examined separately in the next condition.
- Required materials and conditions: S01's original records of endpoint-specific included-trial and participant counts.
- Materials to obtain first: S01's original records of endpoint-specific included-trial and participant counts.
- Further research: Future reviews should link endpoint-specific trials and analysis denominators to original trial families in a public table.
- Conditions for verification: Keep the original 14 LDL-C RCTs/1,447 participants separate from 18 RCTs/1,788 overall; do not use the overall total as LDL-C analysis n.
- Why this condition is needed: This limited record condition prevents confusion between endpoint-specific totals and whole-review size.
- Application exceptions: Do not substitute whole-review or other lipid-endpoint totals for LDL-C analysis denominators or add direct-trial reports to them.
- Remaining uncertainty: This limited record condition prevents confusion between endpoint-specific totals and whole-review size.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01

### N11 · Can S01's included trials and overlap/independent families involving S02–S04 be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The review supplies a total of 14 LDL-C trials but no actual included-trial table. Overlap between S02–S04 and the review cannot be established from this summary alone.
- Why unverified: Review identity and totals are verified, but trial-specific overlap and total unique participants remain unverified.
- Reason for missing information: Review identity and totals are verified, but trial-specific overlap and total unique participants remain unverified.
- Required materials and conditions: S01's included-trial tables, exclusions, original-trial identities and S02–S04 registration/report links.
- Materials to obtain first: S01's included-trial tables, exclusions, original-trial identities and S02–S04 registration/report links.
- Further research: Publish identifiers linking reports, registrations, trials and endpoint-specific analyses; connect duplicates within one family.
- Conditions for verification: Compare included-trial lists and report/registration relationships; do not estimate unverified unique study or participant totals.
- Why this condition is needed: Distinguish report counts from independent replication and retain unknown family relationships honestly.
- Application exceptions: Do not add the review and individual papers as separate independent trials. Retain the identified S02/S03 overlap separately.
- Remaining uncertainty: Distinguish report counts from independent replication and retain unknown family relationships honestly.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N12 · What LDL-C MD and 95% CI did S01 report?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S01's retained result is MD −0.46 mmol/L, 95% CI −0.62~−0.30. It does not establish the expected effect of a specific product or for an individual.
- Why unverified: Attribution of the specified pooled value, unit and interval is verified. Clinical importance and pooling-model validity are separate questions.
- Reason for missing information: Attribution of the specified pooled value, unit and interval is verified. Clinical importance and pooling-model validity are separate questions.
- Required materials and conditions: S01's original pooled LDL-C result record and units.
- Materials to obtain first: S01's original pooled LDL-C result record and units.
- Further research: Publish original-trial estimates, variances and models with the pooled result and specify its applicability.
- Conditions for verification: Link S01's MD −0.46 mmol/L, 95% CI −0.62~−0.30 as a pooled estimate; do not interpret it as a guaranteed product-specific effect.
- Why this condition is needed: Separate verification of reported numbers from assessment of clinical sufficiency.
- Application exceptions: Do not transfer this interval to other formulations, risk groups or event prevention, or calculate a new value.
- Remaining uncertainty: Separate verification of reported numbers from assessment of clinical sufficiency.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01

### N13 · Can S01's weights, model, heterogeneity and sensitivity analyses be verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained text notes geographic concentration, bias and formulation differences and describes pooling direct placebo RCTs. Actual weights, model, heterogeneity statistics and sensitivity results are not supplied.
- Why unverified: The existence of a pooled MD alone does not establish that the analysis model, robustness or trial differences have been explained.
- Reason for missing information: The existence of a pooled MD alone does not establish that the analysis model, robustness or trial differences have been explained.
- Required materials and conditions: Meta-analysis methods, trial-specific effects/variances, heterogeneity measures, sensitivity analyses and analysis code.
- Materials to obtain first: Meta-analysis methods, trial-specific effects/variances, heterogeneity measures, sensitivity analyses and analysis code.
- Further research: Prespecify heterogeneity hypotheses and publish trial-specific results and sensitivity analyses to assess directness by product and population.
- Conditions for verification: Verify fixed/random-effects models, variance handling, endpoint-specific heterogeneity, sensitivity analyses and result selection.
- Why this condition is needed: Examine pooled averages together with between-trial conditions and analysis uncertainty.
- Application exceptions: Do not calculate missing I² or prediction intervals or arbitrarily designate a fixed/random-effects model.
- Remaining uncertainty: Examine pooled averages together with between-trial conditions and analysis uncertainty.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01

### N14 · Can bias and geographic/product representativeness data for S01's included trials be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The article describes geographic concentration and substantial trial bias/formulation differences. Trial-specific assessments and geographic/product composition tables are absent; the original B2 axis is historical judgment metadata.
- Why unverified: Limitations are described, but actual trial-specific bias evidence and applicability data have not been compared.
- Reason for missing information: Limitations are described, but actual trial-specific bias evidence and applicability data have not been compared.
- Required materials and conditions: Included-trial baseline/method tables, geographic composition, product information and result-specific bias-assessment evidence.
- Materials to obtain first: Included-trial baseline/method tables, geographic composition, product information and result-specific bias-assessment evidence.
- Further research: Provide trial-specific evidence for design, missingness, measurement and selective reporting with geography/product/population tables to examine result limitations.
- Conditions for verification: Link trial-specific methods, geography, populations, formulation differences and assessment evidence to actual material.
- Why this condition is needed: Distinguish review-summary limitations from actual assessment evidence.
- Application exceptions: Do not promote the original B2 axis or sample size into a current formal RoB/GRADE judgment or bias magnitude.
- Remaining uncertainty: Distinguish review-summary limitations from actual assessment evidence.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01

### N15 · Can S02's 84 people be distinguished from actual allocation, completion and LDL-C analysis denominators?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S02 records 84 Chinese men. Their flow stage, arm-specific completion counts and LDL-C analysis denominators are absent from this summary.
- Why unverified: The nominal sample size is verified, but inclusion of all 84 in week 12 LDL-C analysis cannot be verified.
- Reason for missing information: The nominal sample size is verified, but inclusion of all 84 in week 12 LDL-C analysis cannot be verified.
- Required materials and conditions: S02 recruitment flow, arm-specific allocation/completion, week 12 LDL-C analysis n and missing-data handling.
- Materials to obtain first: S02 recruitment flow, arm-specific allocation/completion, week 12 LDL-C analysis n and missing-data handling.
- Further research: Report arm-specific flow from allocation through week 12 sampling/analysis, including exclusions and reasons for missingness.
- Conditions for verification: Verify what the reported 84 represents and arm-specific allocation, completion, sampling and analysis n without substituting one count for another.
- Why this condition is needed: Distinguish nominal participant counts from actual result-analysis denominators.
- Application exceptions: Do not add the 84 men reused in S03 as newly recruited participants.
- Remaining uncertainty: Distinguish nominal participant counts from actual result-analysis denominators.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S02, S03

### N16 · What is the scope of S02's week 12 LDL-C result and nonsignificant interpretation?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S02's retained result is MD −0.21 mmol/L, 95% CI −0.50~0.08, P=.15. The original wording calls LDL ineffective; here it is limited to the reported nonsignificant result without declaring an effect of 0 or equivalence.
- Why unverified: The unfavorable direct result and interval remain linked. This status creates no new efficacy or equivalence-test result.
- Reason for missing information: The unfavorable direct result and interval remain linked. This status creates no new efficacy or equivalence-test result.
- Required materials and conditions: S02's LDL-C estimate, interval, P value and original direction description.
- Materials to obtain first: S02's LDL-C estimate, interval, P value and original direction description.
- Further research: Future trials should report target between-arm differences and intervals; if equivalence is claimed, prespecify that hypothesis and its margins separately.
- Conditions for verification: Retain MD −0.21 mmol/L, 95% CI −0.50~0.08, P=.15; do not turn nonsignificance into an effect of 0, equivalence or confirmed harm.
- Why this condition is needed: Prevent significance-based result selection and overinterpretation of no significant difference.
- Application exceptions: Do not delete this nonsignificant result in favor of a positive result in another sex/unit or establish efficacy retrospectively.
- Remaining uncertainty: Prevent significance-based result selection and overinterpretation of no significant difference.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S02

### N17 · Can actual analysis denominators for S03's 100 women and stored samples from 84 men be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S03 specifies 100 women and 84 men and includes analysis of stored samples from the existing male trial. Actual female/male LDL-C analysis denominators and completion counts are absent.
- Why unverified: Nominal counts by sex and the reuse design are verified, but result-specific analysis denominators cannot be newly established.
- Reason for missing information: Nominal counts by sex and the reuse design are verified, but result-specific analysis denominators cannot be newly established.
- Required materials and conditions: S03 female participant flow, arm-specific analysis n and remeasurement/analysis records for existing male specimens.
- Materials to obtain first: S03 female participant flow, arm-specific analysis n and remeasurement/analysis records for existing male specimens.
- Further research: Publish female participant flow and the scope of male specimen reuse separately, linking analysis denominators to results and times.
- Conditions for verification: Verify female recruitment/allocation/completion and LDL analysis n separately from measurement/analysis n for existing male specimens.
- Why this condition is needed: Distinguish reused people/specimens from new recruitment and nominal n from analysis n.
- Application exceptions: Do not turn 100+84 into a new unique-participant total or count stored male samples as a new independent trial.
- Remaining uncertainty: Distinguish reused people/specimens from new recruitment and nominal n from analysis n.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S03, S02

### N18 · Can the SD scale and standardization/adjustment methods for S03 women's LDL be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S03 records women's LDL as −1.06 SD, 95% CI −1.44~−0.69. The SD definition, analysis model and between-arm difference in mmol/L are unverified in this summary.
- Why unverified: The numbers and SD label are specified, but conversion/variance evidence for comparison with mmol/L effect sizes is absent.
- Reason for missing information: The numbers and SD label are specified, but conversion/variance evidence for comparison with mmol/L effect sizes is absent.
- Required materials and conditions: S03 original-unit LDL means, variances, analysis n and SD-scale construction/adjustment methods.
- Materials to obtain first: S03 original-unit LDL means, variances, analysis n and SD-scale construction/adjustment methods.
- Further research: Report original-unit means, variances, between-arm estimates and the SD standardization reference together; analyze different units separately.
- Conditions for verification: Retain women's LDL −1.06 SD, 95% CI −1.44~−0.69 on an SD scale; verify original units, variance and standardization/adjustment methods.
- Why this condition is needed: Keep differences in scale and analysis definition visible.
- Application exceptions: Do not convert SD to mmol/L or SE, or arbitrarily specify a particular raw-mean-difference/SMD calculation.
- Remaining uncertainty: Keep differences in scale and analysis definition visible.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S03

### N19 · Can S03's primary apoB/secondary LDL-C hierarchy be compared with prospective plans and analyses?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S03 describes apoB as the female trial's primary endpoint and LDL as secondary. Planning documents were not read in this work; prospective LDL hierarchy, adjustment and analysis changes were not directly verified.
- Why unverified: The retained summary states a hierarchy, but no evidence establishes comparison with actual prospective plans and reporting.
- Reason for missing information: The retained summary states a hierarchy, but no evidence establishes comparison with actual prospective plans and reporting.
- Required materials and conditions: S03 registration, protocols and analysis plans covering endpoint hierarchy, multiplicity and changes.
- Materials to obtain first: S03 registration, protocols and analysis plans covering endpoint hierarchy, multiplicity and changes.
- Further research: Future trials should prespecify whether LDL-C is primary, the target time, multiplicity handling and analysis-change rules.
- Conditions for verification: Compare the retained female primary apoB/secondary LDL hierarchy with registration/protocol endpoint, time and multiplicity plans.
- Why this condition is needed: Distinguish the interpretation hierarchy of favorable subordinate results from actual plan verification.
- Application exceptions: Do not convert primary apoB results into primary LDL-C confirmation or automatically discard secondary results as invalid.
- Remaining uncertainty: Distinguish the interpretation hierarchy of favorable subordinate results from actual plan verification.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S03

### N20 · Does the retained text connect S02 and S03 male data to the same trial family?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S03 includes stored-sample analysis from the existing male trial, and S02/S03 citations share NCT03770325. The retained text explicitly states these were not counted as two independent LDL confirmations.
- Why unverified: Reuse within the same male family is verified in the current summary. This does not certify total unique trials or participants.
- Reason for missing information: Reuse within the same male family is verified in the current summary. This does not certify total unique trials or participants.
- Required materials and conditions: S02/S03 original citations, designs and textual links to the same male data.
- Materials to obtain first: S02/S03 original citations, designs and textual links to the same male data.
- Further research: Publish a family table linking each report to trial/registration, recruitment, specimens, endpoints and times.
- Conditions for verification: Retain the stored-sample, 84-men and NCT03770325 links; do not count the two reports as independent LDL replications.
- Why this condition is needed: This identity condition directly distinguishes repeat reports from unique studies.
- Application exceptions: Retain new female recruitment while distinguishing shared male data and investigator overlap from independent replication.
- Remaining uncertainty: This identity condition directly distinguishes repeat reports from unique studies.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S02, S03

### N21 · Can S04's 144 enrolled people be distinguished from allocation, completion and LDL-C analysis denominators?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S04 reports 144 enrolled people. Arm-specific allocation/completion and actual 3-month LDL-C analysis denominators are not supplied.
- Why unverified: Only enrollment is known; inclusion of all 144 in comparative analysis cannot be verified.
- Reason for missing information: Only enrollment is known; inclusion of all 144 in comparative analysis cannot be verified.
- Required materials and conditions: S04 enrollment/allocation/completion flow, arm-specific 3-month sampling/analysis n and exclusion reasons.
- Materials to obtain first: S04 enrollment/allocation/completion flow, arm-specific 3-month sampling/analysis n and exclusion reasons.
- Further research: Report arm-specific flow from enrollment through allocation, follow-up and LDL analysis, including missing-data handling.
- Conditions for verification: Distinguish enrollment of 144 from arm-specific randomization, completion and 3-month LDL-C analysis n.
- Why this condition is needed: Separate enrollment from actual analysis denominators.
- Application exceptions: Do not convert enrollment into ITT/PP, completer or placebo/treatment-arm n.
- Remaining uncertainty: Separate enrollment from actual analysis denominators.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S04

### N22 · Can S04's actual between-arm LDL-C effect, unit and CI be verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S04's retained summary says the abstract reports a reduction versus placebo, while explicitly marking the exact between-arm effect and CI unverified.
- Why unverified: A positive-direction summary exists, but effect magnitude, precision and analysis definitions cannot be filled in.
- Reason for missing information: A positive-direction summary exists, but effect magnitude, precision and analysis definitions cannot be filled in.
- Required materials and conditions: S04 arm-specific LDL-C result tables, estimation model, effect value and 95% CI.
- Materials to obtain first: S04 arm-specific LDL-C result tables, estimation model, effect value and 95% CI.
- Further research: Report the prespecified 3-month LDL-C between-arm estimate, variance, denominator and CI in original units.
- Conditions for verification: Verify exact between-arm estimates, units, analysis and intervals separately from the abstract's reduction direction.
- Why this condition is needed: Distinguish directional descriptions from quantitative effects and precision.
- Application exceptions: Do not establish clinical importance from abstract direction alone or copy effects/intervals from other reports.
- Remaining uncertainty: Distinguish directional descriptions from quantitative effects and precision.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S04

### N23 · Are result directions by sex/analysis and prospective subgroup/interaction evidence explaining them verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained text notes nonsignificant male and positive female findings with directional/population heterogeneity. Female SD and male mmol/L are different scales; formal sex-interaction estimates and CIs are not supplied.
- Why unverified: Results differ in direction, but material separating formal effect modification from condition differences is absent. Numerical differences alone are not designated conflict for an identical result.
- Reason for missing information: Results differ in direction, but material separating formal effect modification from condition differences is absent. Numerical differences alone are not designated conflict for an identical result.
- Required materials and conditions: Prospective sex hypotheses, interaction models, original-unit effects/intervals and population/formulation differences across trials.
- Materials to obtain first: Prospective sex hypotheses, interaction models, original-unit effects/intervals and population/formulation differences across trials.
- Further research: Prespecify consistent measures and sex subgroup/interaction models; report estimates and intervals for every group.
- Conditions for verification: Retain S02 nonsignificance, S03 female positivity, S01 averages and S04 direction; verify prospective subgroup/interaction plans, estimates and CIs using the same scale and analysis.
- Why this condition is needed: Distinguish directional heterogeneity, subgroup effects and reporting conflict.
- Application exceptions: Do not establish effects only in women or an effect of 0 in men, or select only favorable directions.
- Remaining uncertainty: Distinguish directional heterogeneity, subgroup effects and reporting conflict.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N24 · Can citation registration numbers and unconfirmed registration fields be compared with actual registration records?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: Citations list PROSPERO and two NCT numbers, but all four evidence-table registration fields say unconfirmed. Current access to and comparison of original registration records totals 0.
- Why unverified: Bibliographic clues exist, but unconfirmed registration fields cannot be overwritten as actual registration verification. S04 registration identity also remains unverified.
- Reason for missing information: Bibliographic clues exist, but unconfirmed registration fields cannot be overwritten as actual registration verification. S04 registration identity also remains unverified.
- Required materials and conditions: Review/trial registration originals, trial identity links for each report and change histories.
- Materials to obtain first: Review/trial registration originals, trial identity links for each report and change histories.
- Further research: Compare official registration identity, interventions, populations, endpoints, times and change histories with reports; record correction reasons separately.
- Conditions for verification: Retain PROSPERO CRD42021293218 and NCT03770325/NCT06782646 clues alongside unconfirmed evidence-table registration fields; verify actual documents and trial links.
- Why this condition is needed: Distinguish bibliographic identifiers from actual registration/plan comparison.
- Application exceptions: Constructing an NCT link does not establish reading registration documents or verifying plan consistency.
- Remaining uncertainty: Distinguish bibliographic identifiers from actual registration/plan comparison.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N25 · Are retained prospective/endpoint-hierarchy summaries and actual LDL-C analysis, timing and reporting consistent with plans?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S01 is described as a preregistered review, S02 as a direct prospective lipid group, and S03 LDL as secondary. There is no current record of externally reading each plan and complete result table.
- Why unverified: Prospective descriptions exist, but original material for checking actual analysis/time consistency and selective reporting remains unverified.
- Reason for missing information: Prospective descriptions exist, but original material for checking actual analysis/time consistency and selective reporting remains unverified.
- Required materials and conditions: S01–S04 protocols/registrations, statistical analysis plans, complete lipid results, changes and multiplicity records.
- Materials to obtain first: S01–S04 protocols/registrations, statistical analysis plans, complete lipid results, changes and multiplicity records.
- Further research: Prespecify LDL-C results, times, analysis populations and multiplicity; publish every planned result and reasons for changes.
- Conditions for verification: Verify retained descriptions of a preregistered review, prospective lipid group and secondary LDL; compare registration/protocol/analysis plans with actual LDL-C results, times and between-arm models, including reasons for changes and multiplicity handling.
- Why this condition is needed: Expose the material needed to examine selection of favorable analyses.
- Application exceptions: Do not turn unavailable plans into confirmed nonregistration or selective reporting.
- Remaining uncertainty: Expose the material needed to examine selection of favorable analyses.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N26 · Can ITT/PP, adjustment and the effect of interest for each LDL-C estimate be verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The current summary provides MD/SD results but no specific analysis-population, effect-of-interest or adjustment-model data. Generic English verification wording does not fill these gaps.
- Why unverified: RCT titles and generic English wording do not establish ITT, PP or a particular analysis model.
- Reason for missing information: RCT titles and generic English wording do not establish ITT, PP or a particular analysis model.
- Required materials and conditions: Result-specific analysis n, ITT/PP definitions, adjustment covariates and statistical analysis plans/models.
- Materials to obtain first: Result-specific analysis n, ITT/PP definitions, adjustment covariates and statistical analysis plans/models.
- Further research: Specify whether assignment effects are primary; distinguish and report actual analysis populations, models and adherence-related supplementary analyses.
- Conditions for verification: Verify assignment/adherence effects, actual analysis populations, adjustment covariates and result definitions.
- Why this condition is needed: Avoid falsely presenting different analyses as the same effect of interest.
- Application exceptions: Do not arbitrarily label unspecified analysis populations ITT or convert within-arm changes into between-arm differences.
- Remaining uncertainty: Avoid falsely presenting different analyses as the same effect of interest.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N27 · Can LDL-C missingness, attrition reasons, arm-specific handling and sensitivity analyses be verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained summary lacks result-specific attrition/missingness counts, reasons and handling tables. There is no evidence that enrollment of 144, 84 men or 100 women equals completion or analysis n.
- Why unverified: Nominal counts alone do not establish missing-data effects or inclusion of all participants.
- Reason for missing information: Nominal counts alone do not establish missing-data effects or inclusion of all participants.
- Required materials and conditions: Arm-specific follow-up losses, missing blood samples, discontinuation reasons, missing-data handling and sensitivity results.
- Materials to obtain first: Arm-specific follow-up losses, missing blood samples, discontinuation reasons, missing-data handling and sensitivity results.
- Further research: Collect arm-specific reasons for loss to follow-up and missing blood samples; report prespecified handling and sensitivity analyses.
- Conditions for verification: Link allocation/completion/analysis flow to LDL-C missingness, discontinuation reasons, handling and sensitivity analyses.
- Why this condition is needed: Distinguish denominator losses from selection in effect estimation.
- Application exceptions: Do not calculate missing attrition counts, CIs or missing-data effects, or turn unverified information into no missingness.
- Remaining uncertainty: Distinguish denominator losses from selection in effect estimation.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N28 · Can funding, product support, author interests and investigator overlap be verified against actual declarations?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: S01 notes mixed original-trial funding and separately unverified review COI; S02 lists Hong Kong's Health and Medical Research Fund; S03 lists the same funding and reports no related COI; S04 funding/product-support details remain unverified. Investigator overlap is also noted.
- Why unverified: Funding/declaration summaries exist, but product provision, employment, institutional relationships and actual declaration documents have not been compared.
- Reason for missing information: Funding/declaration summaries exist, but product provision, employment, institutional relationships and actual declaration documents have not been compared.
- Required materials and conditions: S01 trial/review COI, S02–S04 funding/product support, author declarations and institutional relationships.
- Materials to obtain first: S01 trial/review COI, S02–S04 funding/product support, author declarations and institutional relationships.
- Further research: Disclose funding, supplied products, author employment/declarations and recruitment/research-family relationships separately.
- Conditions for verification: Distinguish the verification scope of report-specific funding, product provision, employment/COI declarations and institutional/research-family links.
- Why this condition is needed: Distinguish independence claims from actual declarations, funding and research families.
- Application exceptions: A report of no COI does not prove no bias or independent replication; funding alone does not justify deleting results.
- Remaining uncertainty: Distinguish independence claims from actual declarations, funding and research families.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N29 · Is there a prospective criterion for judging the clinical importance of this LDL-C difference?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: A pooled MD and some intervals are available, but no important-difference criterion for this question is supplied. The original text also identifies LDL-C as a surrogate endpoint.
- Why unverified: Significance, 14 trials, participant counts and original C50 alone do not establish clinical sufficiency.
- Reason for missing information: Significance, 14 trials, participant counts and original C50 alone do not establish clinical sufficiency.
- Required materials and conditions: Evidence and prospective criteria for important LDL-C differences in dyslipidemia populations, with original-unit results/CIs.
- Materials to obtain first: Evidence and prospective criteria for important LDL-C differences in dyslipidemia populations, with original-unit results/CIs.
- Further research: Justify an important difference appropriate to the population and result; prespecify trial-design and interpretation criteria.
- Conditions for verification: Compare justified important-difference criteria for the population, units and time with reported CIs; do not invent missing thresholds.
- Why this condition is needed: Distinguish reported intervals from judgments of clinical importance.
- Application exceptions: Do not invent universal minimum sample sizes, trial counts, durations or effect thresholds, or import event-prevention thresholds into this measure.
- Remaining uncertainty: Distinguish reported intervals from judgments of clinical importance.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N30 · Are optimal dose or post-discontinuation persistence imposed as additional requirements for this narrow treatment-end LDL-C question?

Verification status: Not applicable  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: This table compares treatment-end LDL-C within the stated formulation, population and duration. It does not select a question establishing optimal dose, persistence after stopping or long-term effects.
- Why unverified: Optimal dose and persistence are not imposed as additional requirements for the current selected question. This does not establish absence of such effects or safety.
- Reason for missing information: Optimal dose and persistence are not imposed as additional requirements for the current selected question. This does not establish absence of such effects or safety.
- Required materials and conditions: The selected-question scope and separate direct evidence if dose/persistence extensions are sought.
- Materials to obtain first: The selected-question scope and separate direct evidence if dose/persistence extensions are sought.
- Further research: Only if an extension is sought, design a separate direct dose comparison or post-discontinuation follow-up question/trial.
- Conditions for verification: Do not add separate optimal-dose or long-term-persistence claims to the selected treatment-end LDL-C question; assess extension material separately.
- Why this condition is needed: This supplementary condition distinguishes the narrow main-effect question from applicability of extension conditions.
- Application exceptions: Do not infer an optimal dose or long-term safety from 900~1,500 mg/day and 4~24 weeks.
- Remaining uncertainty: This supplementary condition distinguishes the narrow main-effect question from applicability of extension conditions.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N31 · Are LDL-C comparisons separated from myocardial infarction, death and statin-replacement questions?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The retained text explicitly describes LDL-C as a surrogate rather than myocardial infarction/death and excludes statin-replacement and cardiovascular-event-prevention wording.
- Why unverified: The boundary between the endpoint and separate clinical questions is directly verified. Event-prevention or medicine-replacement efficacy is not established.
- Reason for missing information: The boundary between the endpoint and separate clinical questions is directly verified. Event-prevention or medicine-replacement efficacy is not established.
- Required materials and conditions: The original endpoint and exclusions covering cardiovascular events and medicine replacement.
- Materials to obtain first: The original endpoint and exclusions covering cardiovascular events and medicine replacement.
- Further research: Event-prevention or medicine-replacement questions require separate research prespecifying the relevant events, comparator and duration.
- Conditions for verification: Keep LDL-C as the selected numerical endpoint; do not claim event prevention or medicine replacement as the same result.
- Why this condition is needed: Distinguish surrogate endpoints from clinical-event extensions.
- Application exceptions: Do not impose event trials as an additional requirement for the numerical-change question or promote numerical effects into event effects.
- Remaining uncertainty: Distinguish surrogate endpoints from clinical-event extensions.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N32 · Are gastrointestinal warnings and actual event definitions, placebo-relative frequencies, denominators and discontinuations verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The safety warning says gastrointestinal adverse effects may be more frequent than with placebo. Event definitions, actual between-arm frequencies, people/event counts, denominators, follow-up and discontinuation reasons are absent from this summary.
- Why unverified: The original warning is retained, but material attributing quantitative harms, incidence and discontinuations is absent.
- Reason for missing information: The original warning is retained, but material attributing quantitative harms, incidence and discontinuations is absent.
- Required materials and conditions: Trial-specific gastrointestinal-event definitions, arm-specific events/exposure/follow-up tables and collection/discontinuation records.
- Materials to obtain first: Trial-specific gastrointestinal-event definitions, arm-specific events/exposure/follow-up tables and collection/discontinuation records.
- Further research: Under the same population/exposure conditions, report prespecified event definitions, systematic collection, arm-specific denominators/duration and discontinuation reasons.
- Conditions for verification: Retain the original warning that gastrointestinal adverse effects may be more frequent than with placebo; separately verify affected people/event counts, arm-specific exposure denominators, duration, collection and discontinuation reasons.
- Why this condition is needed: This supplementary condition is needed because efficacy summaries and short-term RCTs do not establish overall safety.
- Application exceptions: Do not promote reported warnings into new causal/frequency judgments or delete LDL-C results because safety material is unverified.
- Remaining uncertainty: This supplementary condition is needed because efficacy summaries and short-term RCTs do not establish overall safety.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N33 · Are original pregnancy/lactation/infant and CYP-comedication cautions and actual exposure/harm evidence verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The original text calls for clinician review in pregnancy, lactation, infants and use with CYP-related medicines. It supplies no actual exposure, events, timing, denominators or interaction results for those groups.
- Why unverified: Caution groups are verified, but material addressing personal safety, special-population harm magnitude and causality remains unverified.
- Reason for missing information: Caution groups are verified, but material addressing personal safety, special-population harm magnitude and causality remains unverified.
- Required materials and conditions: Population-specific exposure, concomitant medicines, events/timing, baseline risk and direct-material identity.
- Materials to obtain first: Population-specific exposure, concomitant medicines, events/timing, baseline risk and direct-material identity.
- Further research: Collect direct observational and drug-interaction evidence using designs suited to a separate harm question.
- Conditions for verification: Retain original caution groups and wording; separately verify direct exposure, events, timing and alternative-cause evidence for those populations/comedications.
- Why this condition is needed: This supplementary condition separates the selected efficacy population from vulnerable-group/comedication harms.
- Application exceptions: Do not extrapolate vulnerable-group safety from adult lipid trials or turn warnings into personal dosing instructions or established risk rates.
- Remaining uncertainty: This supplementary condition separates the selected efficacy population from vulnerable-group/comedication harms.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N34 · Does the correction about replacing English placeholders match specific values in the current English evidence table?

Verification status: Conflicting data  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The correction says 4 generic verification fields were replaced with specific English, but the current evidence-table sample-size, funding, endpoint and result English fields remain generic. Specific numbers/denominators were read from their Korean locations.
- Why unverified: Current generic English fields directly disagree with the historical description of specific replacements. Before/after correction versions were not acquired, so the event history is not newly established; this is separate from clinical-result conflict.
- Reason for missing information: Current generic English fields directly disagree with the historical description of specific replacements. Before/after correction versions were not acquired, so the event history is not newly established; this is separate from clinical-result conflict.
- Required materials and conditions: Original bytes before/after the 2026-09-14 English correction and specific correspondence of the four current fields.
- Materials to obtain first: Original bytes before/after the 2026-09-14 English correction and specific correspondence of the four current fields.
- Further research: Compare original English bytes before/after correction and record Korean correspondence and reasons for changes. This row does not request additional clinical trials.
- Conditions for verification: Compare the correction description with actual English sample-size, funding, endpoint and result fields; distinguish before/after versions that have not been compared.
- Why this condition is needed: Distinguish historical correction descriptions from current field values.
- Application exceptions: Do not delete the correction record or promote generic current wording into full-text verification or specific denominator/analysis evidence.
- Remaining uncertainty: Distinguish historical correction descriptions from current field values.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N35 · Are original C50, all axes and native values kept separate from approval of new conditions or regrading?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: Original values are C50, Warning and B/S/R0/I2/EX/B2/CX. The co-primary-split, large hard-endpoint RCT, no-human-study and failed-primary/positive-secondary indicators are false, and the original subclaim list is empty. Original values remain in the input.
- Why unverified: Preservation of original judgment metadata and separation from new condition statuses are verified. The original score is not inherited as new efficacy certification or a condition score.
- Reason for missing information: Preservation of original judgment metadata and separation from new condition statuses are verified. The original score is not inherited as new efficacy certification or a condition score.
- Required materials and conditions: Exact original locations for grade, score, axes, original true/false values, arrays, corrections and dates.
- Materials to obtain first: Exact original locations for grade, score, axes, original true/false values, arrays, corrections and dates.
- Further research: When original judgments or evidence are corrected, retain separate events, original bytes and versions; revisit the question boundary first.
- Conditions for verification: Retain original grade, score, axes, true/false values, empty arrays, corrections and dates exactly; separate table statuses from new efficacy grades.
- Why this condition is needed: Traceability distinguishes original judgment from the material-conversion status.
- Application exceptions: Do not convert false into 0 or unrecorded, or expand a false no-human-study indicator into complete verification of every human study.
- Remaining uncertainty: Traceability distinguishes original judgment from the material-conversion status.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N36 · Are locally read summaries separated from external bibliographic, full-text and registration states?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The whole retained summary and exact Korean/English, evidence, citation and correction locations were read. PubMed, PMC, DOI, registrations and original papers were not accessed or read in this work; links do not establish full-text reading.
- Why unverified: Actual local-summary reading and external material states are recorded separately. This does not verify current accuracy of all external content.
- Reason for missing information: Actual local-summary reading and external material states are recorded separately. This does not verify current accuracy of all external content.
- Required materials and conditions: Current input hashes, actual reading scope, material-specific access/acquisition/reading records and original-location links.
- Materials to obtain first: Current input hashes, actual reading scope, material-specific access/acquisition/reading records and original-location links.
- Further research: If future acquisition is authorized, link identity, material type, date, actual location/value and hash to update the relevant rows only.
- Conditions for verification: Connect exact local-summary inputs, locations, identity checks and actual summary reading; separately record unattempted/unread external material.
- Why this condition is needed: Avoid confusing links or acquired summaries with full-text reading.
- Application exceptions: Do not turn unattempted access into failed access or label local summaries as clinical full texts or original-binary reading.
- Remaining uncertainty: Avoid confusing links or acquired summaries with full-text reading.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

### N37 · Can past access levels and dates for each external material be verified from original records?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.

- Current findings: The original verdict-review date is 2026-09-08 and the correction date is 2026-09-14. Individual citations lack access-level/access-date keys; only a whole-record comparison narrative exists. Report-specific historical access dates/levels remain unrecorded.
- Why unverified: The original review date and comparison narrative cannot be copied into individual-paper access dates or full-text reading levels.
- Reason for missing information: The original review date and comparison narrative cannot be copied into individual-paper access dates or full-text reading levels.
- Required materials and conditions: Original acquisition/reading records, access dates, document versions and access levels for each material.
- Materials to obtain first: Original acquisition/reading records, access dates, document versions and access levels for each material.
- Further research: If historical verification material exists, link each document's actual access date, version and location to original records. Do not create missing records retrospectively.
- Conditions for verification: Verify actual original fields for each report's access level/date; distinguish original review, correction and current-review dates.
- Why this condition is needed: Distinguish attribution of original review dates, individual access dates and current reading times.
- Application exceptions: Distinguish current external nonreading from unknown historical reading; do not retrospectively establish that full texts were not read then.
- Remaining uncertainty: Distinguish attribution of original review dates, individual access dates and current reading times.
- Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.
- Related sources: S01, S02, S03, S04

## Evidence and sources

### S01

Blais 2023 placebo-controlled RCT meta-analysis

[PubMed](https://pubmed.ncbi.nlm.nih.gov/36941490/)

Materials actually read: Retained Korean/English summaries, evidence and citations were read. External bibliography, abstracts, full texts, registration and protocols remain unattempted, unacquired and unread.  
Findings recorded in the summary: LDL-C 14 RCTs/1,447 participants: MD −0.46 mmol/L, 95% CI −0.62~−0.30. The whole review has 18 RCTs/1,788 participants. This is not a guaranteed product effect or current certification of unique trials.  
Record level: A retained pooled reported value. Included-trial tables, pooling models, bias and sensitivity analyses were not externally compared in this work.  
Independent replication: Without S01’s actual included-trial table, overlap with S02–S04 remains unverified. S02/S03 share the same male stored-sample family, while new female recruitment is retained separately. S04 is a separate low-risk trial citation. Total unique trials and participants remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained judgment evidence/bibliographic summary | Retained summary acquired/read | Retained copy acquired; summary read | Stored existing review summary read | Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External PubMed bibliography/abstract gateway | Public availability unverified | External access not attempted; not acquired | Not read | A retained citation URL gateway. Current external document existence, content, access and reading were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External DOI bibliographic gateway | Public availability unverified | External access not attempted; not acquired | Not read | A bibliographic gateway formed from the original DOI; it does not establish a direct publisher full-text address or acquisition. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| Article full text; direct address unverified | Public availability unverified | External access not attempted; not acquired | Not read | Original article full text remains unacquired/unread. A bibliographic gateway is not converted into a direct publisher full-text address. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| Original prospective review-registration material | Public availability unverified | External access not attempted; not acquired | Not read | The registration number is a retained bibliographic clue. Preserve the unconfirmed evidence-table registration field; actual registration access, reading and plan comparison were not performed. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |

### S02

Chan 2021 male 12-week trial

[Official source](https://pmc.ncbi.nlm.nih.gov/articles/PMC8401658/)

Materials actually read: Retained Korean/English summaries, evidence and citations were read. External bibliography, abstracts, full texts, registration and protocols remain unattempted, unacquired and unread.  
Findings recorded in the summary: Week 12 LDL-C MD −0.21 mmol/L, 95% CI −0.50~0.08, P=.15. Nonsignificance does not establish an effect of 0 or equivalence.  
Record level: A retained direct reported value. Actual allocation, completion and analysis denominators, measurement methods and models remain unverified.  
Independent replication: Without S01’s actual included-trial table, overlap with S02–S04 remains unverified. S02/S03 share the same male stored-sample family, while new female recruitment is retained separately. S04 is a separate low-risk trial citation. Total unique trials and participants remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained judgment evidence/bibliographic summary | Retained summary acquired/read | Retained copy acquired; summary read | Stored existing review summary read | Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External PMC article HTML full-text gateway | Public availability unverified | External access not attempted; not acquired | Not read | A retained PMC HTML full-text gateway. Distinguish its URL from current full-text acquisition/reading; external access was not attempted in this work. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External DOI bibliographic gateway | Public availability unverified | External access not attempted; not acquired | Not read | A bibliographic gateway formed from the original DOI; it does not establish a direct publisher full-text address or acquisition. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| Trial protocol/analysis plan; direct address unverified | Public availability unverified | External access not attempted; not acquired | Not read | Registration-identifier clues are separate from actual protocol/analysis-plan acquisition and reading. Direct addresses remain unverified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External original trial-registration material | Public availability unverified | External access not attempted; not acquired | Not read | Retain citation registration-number clues alongside unconfirmed evidence-table fields. A link does not establish registration-version or plan verification. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |

### S03

Zhao 2026 sex/stored-sample report

[PubMed](https://pubmed.ncbi.nlm.nih.gov/42470424/)

Materials actually read: Retained Korean/English summaries, evidence and citations were read. External bibliography, abstracts, full texts, registration and protocols remain unattempted, unacquired and unread.  
Findings recorded in the summary: Women’s week 12 LDL −1.06 SD, 95% CI −1.44~−0.69. The original summary describes a larger effect than in men, but formal interaction, SD definitions, original units and denominators remain unverified. Distinguish primary apoB from secondary LDL.  
Record level: A retained SD-scale reported value, not converted into mmol/L. Prospective plans, multiplicity and actual analyses were not externally compared in this work.  
Independent replication: Without S01’s actual included-trial table, overlap with S02–S04 remains unverified. S02/S03 share the same male stored-sample family, while new female recruitment is retained separately. S04 is a separate low-risk trial citation. Total unique trials and participants remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained judgment evidence/bibliographic summary | Retained summary acquired/read | Retained copy acquired; summary read | Stored existing review summary read | Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External PubMed bibliography/abstract gateway | Public availability unverified | External access not attempted; not acquired | Not read | A retained citation URL gateway. Current external document existence, content, access and reading were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External DOI bibliographic gateway | Public availability unverified | External access not attempted; not acquired | Not read | A bibliographic gateway formed from the original DOI; it does not establish a direct publisher full-text address or acquisition. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| Article full text; direct address unverified | Public availability unverified | External access not attempted; not acquired | Not read | Original article full text remains unacquired/unread. A bibliographic gateway is not converted into a direct publisher full-text address. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External original trial-registration material | Public availability unverified | External access not attempted; not acquired | Not read | Retain citation registration-number clues alongside unconfirmed evidence-table fields. A link does not establish registration-version or plan verification. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |

### S04

Derosa 2013 low-risk lipid trial

[PubMed](https://pubmed.ncbi.nlm.nih.gov/23441841/)

Materials actually read: Retained Korean/English summaries, evidence and citations were read. External bibliography, abstracts, full texts, registration and protocols remain unattempted, unacquired and unread.  
Findings recorded in the summary: 144 enrolled, 3-month LDL-C. Only a summary saying the abstract reported a reduction versus placebo is available; the exact between-arm effect and CI remain unverified.  
Record level: A retained direction-only summary. Do not turn enrollment into allocation, completion or analysis denominators, or fill effects/intervals from other reports.  
Independent replication: Without S01’s actual included-trial table, overlap with S02–S04 remains unverified. S02/S03 share the same male stored-sample family, while new female recruitment is retained separately. S04 is a separate low-risk trial citation. Total unique trials and participants remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained judgment evidence/bibliographic summary | Retained summary acquired/read | Retained copy acquired; summary read | Stored existing review summary read | Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External PubMed bibliography/abstract gateway | Public availability unverified | External access not attempted; not acquired | Not read | A retained citation URL gateway. Current external document existence, content, access and reading were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External DOI bibliographic gateway | Public availability unverified | External access not attempted; not acquired | Not read | A bibliographic gateway formed from the original DOI; it does not establish a direct publisher full-text address or acquisition. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| Article full text; direct address unverified | Public availability unverified | External access not attempted; not acquired | Not read | Original article full text remains unacquired/unread. A bibliographic gateway is not converted into a direct publisher full-text address. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |
| External original trial-registration material | Public availability unverified | External access not attempted; not acquired | Not read | Retain citation registration-number clues alongside unconfirmed evidence-table fields. A link does not establish registration-version or plan verification. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.

## What the statuses mean

- Met: Verification of a scoped identity, record or boundary; not a new efficacy conclusion
- Partly verified: Some actual retained information is available alongside remaining material needs
- Unverified: Required material is unverified within the retained scope; this does not mean no studies, an effect of 0 or safety
- Conflicting data: Mismatch between specific current fields and historical correction descriptions; separate from clinical-result conflict
- Not applicable: Separate extension conditions are not imposed as additional requirements for the narrow selected question

## Change history

2026-10-27 · Public page/materials 1.0. The public view and materials were prepared from the existing 37 items. No new clinical search, verification-state change or scoring was performed.