# High-dose green tea extract capsules · Original findings not supporting liver-enzyme safety

Verdict 2962 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

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: The MGTT safety analysis included 1,021 postmenopausal women aged 50-70 with normal baseline enzymes (513 extract/508 placebo). The original accounts of three excluded for missing baseline values and 51 withdrawing before the first monthly test are retained separately; no new randomized total or exclusion sum is calculated. Endpoint/test-specific observed denominators, missingness and event/person/repeated-measure details are unverified.
- Ingredient, formulation and route: Original research exposure: high-dose green tea extract capsules providing about 843 mg EGCG daily. Full composition, caffeine/co-ingredients, batches/quality and individual actual exposures are unverified. This is not converted into brewed tea, low-dose formulations or total extract quantities, and no intake/product recommendations or treatment methods are created.
- Dose: The original exposure descriptions are distinguished: MGTT about 843 mg EGCG daily for 12 months, versus EFSA-related at least 800 mg for at least four months and brewed tea/extracts of 316 mg or less. Individual exposure/interruption/re-exposure, other doses/durations and original test denominators are unverified. Historical monitoring/interruption thresholds remain trial procedures, without intake-change, rechallenge or testing instructions.
- Comparator: Prespecified safety analysis of a double-blind placebo-controlled trial. Historical accounts of IDS-pharmacy computer-generated permuted-block randomization, masking of researchers/participants/laboratory staff/outcome assessors, prespecified exclusions and registration correspondence are retained. Placebo identity/matching, actual implementation, concurrent exposures and original plans/analyses remain unread and are not inherited as current B0/causal verification.
- Measured outcome: The selected CTCAE grade 2-or-higher liver-function outcome is retained: 26 women (5.1%), OR 7.0 versus placebo (95% CI 2.4-20.3), P=.0002. Comparator events and actual observed components/model are unverified. ALT +5.4 U/L (3.6-7.1), AST +3.8 U/L (2.5-5.1), each P<.001; all ALT events 53 (6.7%) versus 4 (0.7%); one grade 4 case/peak 2,055, six grade 3 and seven grade 2 cases are separate original measures/units. They are not combined or reconciled under a common denominator; no new effect, confidence interval or incidence is calculated.
- Duration: MGTT’s 12 months are distinguished from monthly testing for the first six months, tests at months 9 and 12, and enzyme changes following interruption/rechallenge. Actual individual testing/missingness, interruption/re-exposure timing and later follow-up/long-term outcomes are unverified. Different EFSA exposure durations are not used as the same trial duration.
- Questions outside this scope: Changing liver-enzyme safety D/note into a new safe verdict, weak harm or confirmation of increased liver failure/death; Mixing events/people, denominators or estimates for 26 women/OR 7, continuous ALT/AST, all ALT events 53/4 and grade-specific cases/peaks, or calculating new incidence/confidence intervals; Calculating a new total randomized population or exclusion sum from 1,021, three missing baseline values and 51 withdrawals before testing; Certifying MGTT’s prespecified safety analysis, repeated tests/rechallenge, the EFSA synthesis or other disease populations as independent replication under the same conditions; Converting unverified signals for tea, lower doses or other durations into a universally safe dose, intake recommendation or product conversion; Turning historical testing/interruption/rechallenge procedures into individual monitoring, intake-change or treatment instructions; Converting manufacturing/quality roles, unreported support or no-conflict declarations into absence of each support type or newly verified independence; Inheriting parent scores/axes, historical cross-checks or registration descriptions as subclaim scores, current verification or external reading; New calculations, invented values, effects/confidence intervals, grades, independence certification or instructions for lifestyle, product intake, testing or treatment

## Checklist items

### N01 · Selected liver-enzyme safety claim and original values

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original high-dose capsule liver-enzyme safety subclaim is D, retaining the note that moderate-or-worse abnormalities increased significantly. Parent D34/Warning is original verdict context. D does not mean weak harm or establish increased liver failure.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Subclaim score, status and axes are absent; parent values are not used to fill them. No new efficacy or harm grade is assigned. Existing content review is incomplete.
- Reason for missing information: Subclaim score, status and axes are absent; parent values are not used to fill them. No new efficacy or harm grade is assigned.
- Required materials and conditions: Distinguish the selected claim and original grade/note from the parent verdict, axes and values
- Materials to obtain first: Selected subclaim and parent verdict/harm-scope materials
- Further research: Update research linking the original question with additional material; no new search, calculation or trial was performed here.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish the selected claim and original grade/note from the parent verdict, axes and values must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish the selected claim and original grade/note from the parent verdict, axes and values and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and internal design; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01, S02

### N02 · Normal liver enzymes and postmenopausal women

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The MGTT analysis included 1,021 postmenopausal women aged 50-70 with normal baseline liver enzymes: 513 receiving extract and 508 placebo.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Baseline characteristics, detailed eligibility, liver disease and other risks, and observed populations by group/time are unverified. The same harm magnitude is not transferred to other disease populations. Existing content review is incomplete.
- Reason for missing information: Baseline characteristics, detailed eligibility, liver disease and other risks, and observed populations by group/time are unverified. The same harm magnitude is not transferred to other disease populations.
- Required materials and conditions: Original population, baseline liver enzymes, recruitment and eligibility scope
- Materials to obtain first: Recruitment/eligibility, baseline characteristics and observed-population materials
- Further research: Proposed follow-up research on population-specific applicability of harm; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Original population, baseline liver enzymes, recruitment and eligibility scope must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Original population, baseline liver enzymes, recruitment and eligibility scope and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S01

### N03 · High-dose capsules and EGCG 843 mg

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original research exposure was green tea extract capsules providing about 843 mg EGCG daily. EGCG quantity is not converted into total extract quantity or brewed-tea intake.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Full composition, caffeine/co-ingredients, batches, individual actual exposure and original quality/adherence data are unverified. No new conversion or intake method is created. Existing content review is incomplete.
- Reason for missing information: Full composition, caffeine/co-ingredients, batches, individual actual exposure and original quality/adherence data are unverified. No new conversion or intake method is created.
- Required materials and conditions: Formulation, constituent exposure and product identity
- Materials to obtain first: Product identity, constituents/batches, actual exposure and quality materials
- Further research: Proposed follow-up research on formulation/exposure differences and applicability of harm; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Formulation, constituent exposure and product identity must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Formulation, constituent exposure and product identity and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S01

### N04 · Placebo and correspondence between groups

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The double-blind placebo-controlled safety analysis populations of 513 receiving extract and 508 placebo are retained.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Placebo identity, sensory matching, concurrent exposures and actual implementation/adherence details are unverified. Group denominators are not reused as the same denominator for every event. Existing content review is incomplete.
- Reason for missing information: Placebo identity, sensory matching, concurrent exposures and actual implementation/adherence details are unverified. Group denominators are not reused as the same denominator for every event.
- Required materials and conditions: Actual placebo/coexisting conditions compared with the study exposure
- Materials to obtain first: Placebo, group exposure/adherence and coexisting-condition materials
- Further research: Proposed follow-up research distinguishing the comparison from actual exposure; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Actual placebo/coexisting conditions compared with the study exposure must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Actual placebo/coexisting conditions compared with the study exposure and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP
- Related sources: S01

### N05 · Twelve months and observation time

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The 12 months of the MGTT safety analysis are retained. Individual exposure/testing/interruption and evidence for other durations in EFSA are distinguished.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Individual start/interruption, actual dosing/testing windows, withdrawal and follow-up completeness, and post-study outcomes are unverified. Existing content review is incomplete.
- Reason for missing information: Individual start/interruption, actual dosing/testing windows, withdrawal and follow-up completeness, and post-study outcomes are unverified.
- Required materials and conditions: Exposure, testing, interruption and actual follow-up windows
- Materials to obtain first: Individual exposure, testing and interruption/follow-up timing materials
- Further research: Proposed follow-up research distinguishing time and cumulative/repeated harm; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Exposure, testing, interruption and actual follow-up windows must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Exposure, testing, interruption and actual follow-up windows and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S01

### N06 · Randomizing pharmacy and permuted blocks

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved account identifies the IDS pharmacy at University of Minnesota Medical Center-Fairview and computer-generated permuted-block randomization. Historical B0 descriptions are not inherited as verification of procedures in this run.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Actual assignment/access permissions, concealment, change history and original records have not been read. Existing content review is incomplete.
- Reason for missing information: Actual assignment/access permissions, concealment, change history and original records have not been read.
- Required materials and conditions: Original randomization/concealment description and actual materials
- Materials to obtain first: Original assignment procedures and access/change records
- Further research: Proposed follow-up research on randomization and the relationship between comparison groups; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Original randomization/concealment description and actual materials must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Original randomization/concealment description and actual materials and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP; M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N07 · Masking of researchers and laboratory staff

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account of double masking is retained: study staff, participants, laboratory personnel and those assessing outcomes were unaware of assignment.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Actual maintenance/unmasking by role, testing/assessment procedures and original materials have not been read. Absence of all measurement bias is not certified. Existing content review is incomplete.
- Reason for missing information: Actual maintenance/unmasking by role, testing/assessment procedures and original materials have not been read. Absence of all measurement bias is not certified.
- Required materials and conditions: Masking and implementation by measurement/assessment role
- Materials to obtain first: Role-specific masking and testing/assessment records
- Further research: Proposed follow-up research on measurement/assessment bias and harm verification; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Masking and implementation by measurement/assessment role must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Masking and implementation by measurement/assessment role and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP
- Related sources: S01

### N08 · Prespecified safety analysis and breast density

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The MGTT efficacy primary endpoint was breast density; the selected verdict concerns a prespecified safety analysis of CTCAE grade 2-or-higher liver-function abnormality. Liver-enzyme outcomes are not relabeled as the efficacy primary endpoint or a minimum important efficacy difference.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Original registration/protocol/SAP, safety hierarchy/multiplicity and change-history details have not been read. Existing content review is incomplete.
- Reason for missing information: Original registration/protocol/SAP, safety hierarchy/multiplicity and change-history details have not been read.
- Required materials and conditions: Relationship between the trial efficacy primary endpoint and the selected safety analysis
- Materials to obtain first: Original efficacy/safety hierarchy and analysis-plan materials
- Further research: Proposed follow-up research distinguishing plans from safety reporting; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Relationship between the trial efficacy primary endpoint and the selected safety analysis must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Relationship between the trial efficacy primary endpoint and the selected safety analysis and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N09 · Definition of CTCAE grade 2 or higher

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Moderate-or-worse abnormality in any liver-function measure, CTCAE grade 2 or higher, is retained as the selected outcome. All ALT elevations, grade-specific cases and liver failure are different endpoints.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. The CTCAE version, test-specific thresholds/components, repeated/peak measurements, event assessment and duplicate handling are unverified in original materials. Existing content review is incomplete.
- Reason for missing information: The CTCAE version, test-specific thresholds/components, repeated/peak measurements, event assessment and duplicate handling are unverified in original materials.
- Required materials and conditions: Selected liver-function abnormality definition, components, assessment and event units
- Materials to obtain first: Original definitions, tests/grades and assessment/duplicate-handling materials
- Further research: Proposed follow-up research on differences arising from harm-endpoint/event definitions; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Selected liver-function abnormality definition, components, assessment and event units must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Selected liver-function abnormality definition, components, assessment and event units and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N10 · Twenty-six women, 5.1% and denominators

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The extract-group result of 26 women (5.1%) and normal-baseline-enzyme analysis populations of 513/508 are retained. Comparator events are not filled from the four total ALT events or the OR.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Comparator events for the selected endpoint, actual observed denominators/missingness and repeated/component correspondence are unverified. No new incidence or event total is calculated. Existing content review is incomplete.
- Reason for missing information: Comparator events for the selected endpoint, actual observed denominators/missingness and repeated/component correspondence are unverified. No new incidence or event total is calculated.
- Required materials and conditions: People, denominators and group correspondence for selected moderate-or-worse abnormalities
- Materials to obtain first: Group-specific people/denominators and observation/event data for the selected endpoint
- Further research: Proposed follow-up research using the same harm endpoint and denominator definitions; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for People, denominators and group correspondence for selected moderate-or-worse abnormalities must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing People, denominators and group correspondence for selected moderate-or-worse abnormalities and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation
- Related sources: S01

### N11 · OR7.0·CI·P

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: OR 7.0 versus placebo (95% CI 2.4-20.3), P=.0002 is retained. The bibliographic summary saying sevenfold is not converted into RR 7, new absolute risk or causal confirmation.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. The model, adjustments/group data, exact outputs and sensitivity analyses have not been read. No new RR, NNT, effect or confidence interval is calculated. Existing content review is incomplete.
- Reason for missing information: The model, adjustments/group data, exact outputs and sensitivity analyses have not been read. No new RR, NNT, effect or confidence interval is calculated.
- Required materials and conditions: Original comparative estimate, precision and model
- Materials to obtain first: Original analysis and exact outputs for the selected comparison
- Further research: Proposed follow-up research on harm estimates and uncertainty; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Original comparative estimate, precision and model must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Original comparative estimate, precision and model and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP
- Related sources: S01

### N12 · Original between-group ALT and AST values

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original descriptions of ALT +5.4 U/L versus placebo (95% CI 3.6-7.1) and AST +3.8 U/L (2.5-5.1), both P<.001, are retained. These estimates differ from the 26 women/event OR.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Final values versus changes, models, actual assessment times/populations, repeated-measure handling and group values remain unverified in detail. No new mean, effect or confidence interval is calculated. Existing content review is incomplete.
- Reason for missing information: Final values versus changes, models, actual assessment times/populations, repeated-measure handling and group values remain unverified in detail. No new mean, effect or confidence interval is calculated.
- Required materials and conditions: Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence
- Materials to obtain first: Continuous-outcome estimate, time, model and observed-population materials
- Further research: Proposed follow-up research distinguishing continuous enzymes from threshold events; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N13 · Total ALT events: 53 versus 4

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description of all ALT elevations, 53 events (6.7%) versus 4 (0.7%), is retained. These are not reused as the same events/denominators for the selected 26 women or grade 2-or-higher endpoint.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Event/person units, repeated visits, thresholds, observed denominators and correspondence with reported percentages are unverified in detail. Original percentages are not recalculated/corrected and events are not added together. Existing content review is incomplete.
- Reason for missing information: Event/person units, repeated visits, thresholds, observed denominators and correspondence with reported percentages are unverified in detail. Original percentages are not recalculated/corrected and events are not added together.
- Required materials and conditions: Definition, units and denominators of all ALT-elevation events
- Materials to obtain first: All-ALT definitions, person/event units and denominator/repeated-measure materials
- Further research: Proposed follow-up research on event units and harm components; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Definition, units and denominators of all ALT-elevation events must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Definition, units and denominators of all ALT-elevation events and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation
- Related sources: S01

### N14 · Severe grades and peak ALT

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original descriptions are retained: one grade 4 case with peak ALT 2,055 U/L, six grade 3 cases and seven grade 2 cases, all in the extract group. They are not combined/reconciled with the 26 women to create a new distribution.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Grade-specific people/events, assessment/peak times, overlap and correspondence with the selected 26 women/all ALT events are unverified. Existing content review is incomplete.
- Reason for missing information: Grade-specific people/events, assessment/peak times, overlap and correspondence with the selected 26 women/all ALT events are unverified.
- Required materials and conditions: Relationship of grade-specific cases and peak values to the selected endpoint
- Materials to obtain first: Grade-specific cases, timing, overlap and endpoint correspondence materials
- Further research: Proposed follow-up research distinguishing severity from repeated outcomes in the same person; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Relationship of grade-specific cases and peak values to the selected endpoint must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Relationship of grade-specific cases and peak values to the selected endpoint and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP
- Related sources: S01

### N15 · Responses after withdrawal and rechallenge

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account of normalization after withdrawal and renewed elevation on rechallenge is retained. This table does not instruct withdrawal or rechallenge.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Numbers of people, timing, exposure quantities, other causes, selection for rechallenge and individual case/comparator details have not been read. Existing content review is incomplete.
- Reason for missing information: Numbers of people, timing, exposure quantities, other causes, selection for rechallenge and individual case/comparator details have not been read.
- Required materials and conditions: Relationship between exposure/interruption/re-exposure, changes and assessment
- Materials to obtain first: Individual exposure/testing, interruption/re-exposure and relatedness-assessment materials
- Further research: Proposed follow-up research on time/re-exposure responses and causal limits; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Relationship between exposure/interruption/re-exposure, changes and assessment must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Relationship between exposure/interruption/re-exposure, changes and assessment and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N16 · Monthly monitoring and months 9/12

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original study procedure of monthly testing for the first six months and then at months 9 and 12 is preserved as history. It is not turned into new individual testing/monitoring instructions.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Actual individual testing, missing tests, additional assessment after abnormalities and monitoring differences between groups are unverified. Existing content review is incomplete.
- Reason for missing information: Actual individual testing, missing tests, additional assessment after abnormalities and monitoring differences between groups are unverified.
- Required materials and conditions: Original trial testing frequency and actual observations/missingness
- Materials to obtain first: Actual testing schedules and missing/additional-assessment records
- Further research: Proposed follow-up research on monitoring frequency and detected/missed harm; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Original trial testing frequency and actual observations/missingness must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Original trial testing frequency and actual observations/missingness and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation
- Related sources: S01

### N17 · Original interruption rules and safety thresholds

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original monitoring procedures are retained: immediate interruption at ALT>1.5 times the upper limit of normal and permanent discontinuation for grade 3/4. These are not minimum important efficacy differences, universal safe doses or new discontinuation/treatment methods.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. The original plan, actual implementation/deviations, related assessments and original test values have not been read. No prescribing/intake-change instructions are created. Existing content review is incomplete.
- Reason for missing information: The original plan, actual implementation/deviations, related assessments and original test values have not been read. No prescribing/intake-change instructions are created.
- Required materials and conditions: Distinguish trial procedure thresholds from outcome/efficacy criteria
- Materials to obtain first: Original trial plans, actual procedure implementation and event materials
- Further research: Proposed follow-up research on how monitoring/interruption rules affected observed outcomes; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish trial procedure thresholds from outcome/efficacy criteria must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish trial procedure thresholds from outcome/efficacy criteria and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP
- Related sources: S01

### N18 · 1,021 participants, three missing baselines and 51 withdrawals

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original descriptions are retained separately: 1,021 safety-analysis participants (513/508), three excluded for missing baseline values and 51 withdrawing before the first monthly test. No new total randomized population or exclusion sum is calculated.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Group-specific exclusions, missing baseline/follow-up tests, actual observed flow, original full recruitment and sensitivity analyses are unverified. Existing content review is incomplete.
- Reason for missing information: Group-specific exclusions, missing baseline/follow-up tests, actual observed flow, original full recruitment and sensitivity analyses are unverified.
- Required materials and conditions: Prespecified safety-analysis population, exclusions and missingness
- Materials to obtain first: Full population to safety analysis to endpoint-specific observation flow, exclusions and missingness materials
- Further research: Proposed follow-up research on selected populations and missing-data assumptions; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Prespecified safety-analysis population, exclusions and missingness must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Prespecified safety-analysis population, exclusions and missingness and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; CHAMGAP adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP
- Related sources: S01

### N19 · Registration NCT and historical prespecification

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: NCT00917735 and historical B0 descriptions of correspondence with the prespecified safety analysis are retained. Registration full text or actual prespecified plans are not claimed to have been read/verified in this run.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Original registration history, protocol/SAP, plan/report timing, changes and multiplicity have not been read. Existing content review is incomplete.
- Reason for missing information: Original registration history, protocol/SAP, plan/report timing, changes and multiplicity have not been read.
- Required materials and conditions: Registration identity, safety plans/changes and correspondence with original reports
- Materials to obtain first: Registration history, protocol/SAP and report-correspondence materials
- Further research: Proposed follow-up research on prespecified plans and safety reporting; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Registration identity, safety plans/changes and correspondence with original reports must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Registration identity, safety plans/changes and correspondence with original reports and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and internal design; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N20 · Concurrent exposures and other causes

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: The scope of comparison between the particular high-dose capsules and placebo is retained.
- Why unverified: Information currently required is unverified in the stored summary. Medications/products, alcohol, diseases, infections, food/fasting, actual adherence, crossover and cause-specific assessments are unverified. No new medical-history/testing or treatment instructions are created. Existing content review is incomplete.
- Reason for missing information: Medications/products, alcohol, diseases, infections, food/fasting, actual adherence, crossover and cause-specific assessments are unverified. No new medical-history/testing or treatment instructions are created.
- Required materials and conditions: Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes
- Materials to obtain first: Concurrent exposures, baseline/follow-up diseases and individual event/relatedness materials
- Further research: Proposed follow-up research on coexisting factors and attribution of harm; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01

### N21 · NIH/NCI funding

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original description of federal NIH/NCI grant support is retained.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Contracts, roles, participation in analysis/writing/publication and individual original disclosures have not been read. Public funding alone does not certify all independence. Existing content review is incomplete.
- Reason for missing information: Contracts, roles, participation in analysis/writing/publication and individual original disclosures have not been read. Public funding alone does not certify all independence.
- Required materials and conditions: Distinguish funding, roles and analysis/publication support
- Materials to obtain first: Original funding/role, contribution and publication disclosures
- Further research: Proposed follow-up research on support roles and outcome reporting; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish funding, roles and analysis/publication support must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish funding, roles and analysis/publication support and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N22 · Manufacturing and quality-testing roles

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original descriptions that Corban Laboratories manufactured capsules and Taiyo International and research institutions participated in quality testing are retained.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Supply/free provision, batches/test contents, quality results and each institution’s analysis/writing/publication roles are unverified. Manufacturing/testing alone does not fill details of free support. Existing content review is incomplete.
- Reason for missing information: Supply/free provision, batches/test contents, quality results and each institution’s analysis/writing/publication roles are unverified. Manufacturing/testing alone does not fill details of free support.
- Required materials and conditions: Individual institutions and roles in manufacturing and quality testing
- Materials to obtain first: Manufacturing/supply, batches/quality testing and institution-specific role materials
- Further research: Proposed follow-up research on product/institution roles and study relationships; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Individual institutions and roles in manufacturing and quality testing must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Individual institutions and roles in manufacturing and quality testing and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed
- Related sources: S01

### N23 · Unreported manufacturer support and conflict declarations

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account says manufacturer support for research funding, analysis, medical writing or publication costs was not reported, and authors reported no conflicts of interest.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Non-reporting/declarations are not converted into verified absence of each support type, employee authors or actual conflicts. Individual disclosures/relationships have not been read. Existing content review is incomplete.
- Reason for missing information: Non-reporting/declarations are not converted into verified absence of each support type, employee authors or actual conflicts. Individual disclosures/relationships have not been read.
- Required materials and conditions: Separate disclosures of research/analysis/medical-writing/publication funding and author relationships
- Materials to obtain first: Original disclosures for each support type, author employment/contributions and conflicts of interest
- Further research: Proposed follow-up research on the scope and gaps of individual support/declarations; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Separate disclosures of research/analysis/medical-writing/publication funding and author relationships must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Separate disclosures of research/analysis/medical-writing/publication funding and author relationships and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N24 · EFSA scientific opinion and report relationships

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: S02 is the EFSA ANS Panel 2018 scientific opinion, rather than a new independent RCT. The preserved conclusion associating long-term use of at least 800 mg EGCG from extracts with liver-enzyme elevation is connected.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Included trials/populations/denominators, MGTT correspondence and quality/funding/protocol details have not been read externally. The synthesis is not certified as independent replication under the same conditions. Existing content review is incomplete.
- Reason for missing information: Included trials/populations/denominators, MGTT correspondence and quality/funding/protocol details have not been read externally. The synthesis is not certified as independent replication under the same conditions.
- Required materials and conditions: Synthesis identity, included materials and relationship to the original trial
- Materials to obtain first: Original EFSA opinion, included materials/populations, MGTT relationships and disclosures
- Further research: Proposed follow-up research distinguishing syntheses from individual trials; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Synthesis identity, included materials and relationship to the original trial must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Synthesis identity, included materials and relationship to the original trial and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP; M04 §4.6.1–4.6.2; Adaptation for harm materials is internally designed; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S02

### N25 · 800 mg/four months, 316 mg and brewed tea

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original EFSA-related descriptions are retained: at least 800 mg for at least four months, and the same signal unverified for brewed tea and extracts of 316 mg or less. This scope differs from MGTT’s 843 mg/12 months.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Trials/populations/observations, denominators and precision for each exposure are unverified. No universal safety certification, recommended dose or product conversion is created for lower doses/tea. Existing content review is incomplete.
- Reason for missing information: Trials/populations/observations, denominators and precision for each exposure are unverified. No universal safety certification, recommended dose or product conversion is created for lower doses/tea.
- Required materials and conditions: Scope of other formulations/doses, durations and observed signals
- Materials to obtain first: Actual materials, denominators and estimates by formulation, dose and duration
- Further research: Proposed follow-up research distinguishing exposure differences and applicability of harm signals; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Scope of other formulations/doses, durations and observed signals must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Scope of other formulations/doses, durations and observed signals and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01, S02

### N26 · Other disease populations and studies without reported abnormalities

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account describes same-direction high-dose signals in HPV lesions, multiple sclerosis, breast cancer and CLL, without independent replication in the same population/comparison, and small studies without reported abnormalities.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Individual study bibliographies, group exposures, events/denominators, harm collection and precision are not individually connected in the current stored summary and remain unverified. No new reports are created. Existing content review is incomplete.
- Reason for missing information: Individual study bibliographies, group exposures, events/denominators, harm collection and precision are not individually connected in the current stored summary and remain unverified. No new reports are created.
- Required materials and conditions: Population, formulation, comparison and identity of contrary/same-direction evidence
- Materials to obtain first: Each study/population, exposure and harm material mentioned in the original account
- Further research: Proposed follow-up research distinguishing population-specific signals from contrary evidence; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Population, formulation, comparison and identity of contrary/same-direction evidence must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Population, formulation, comparison and identity of contrary/same-direction evidence and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M19 §19.2.2–19.2.4, M03 §3.2.3; CHAMGAP adaptation; M04 §4.6.1–4.6.2; Adaptation for harm materials is internally designed; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S01, S02

### N27 · Liver failure and death not established

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original account that increased liver failure/death was not established and the separate ? subclaim note are retained as context. Enzyme signals are not treated as evidence of increased occurrence of those events.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Clinical event definitions, collection, events/denominators, follow-up/precision and power are unverified. Non-establishment is not converted into zero events, zero risk or safety confirmation. Existing content review is incomplete.
- Reason for missing information: Clinical event definitions, collection, events/denominators, follow-up/precision and power are unverified. Non-establishment is not converted into zero events, zero risk or safety confirmation.
- Required materials and conditions: Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes
- Materials to obtain first: Actual liver-failure/death definitions, observations/events and follow-up materials
- Further research: Proposed follow-up research distinguishing enzyme abnormalities from severe clinical outcomes; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run
- Related sources: S01, S02

### N28 · Same trial, repeated testing and independence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: MGTT safety is an analysis of the same original trial. Monthly tests, rechallenge, groups/grades/events, bibliographies, EFSA and sibling sheets are not added as new independent trials/participants. Original R1/D statements about absent same-condition replication remain verdict history.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Unique trials/people, individual repeats/synthesis correspondence and external comparison of actual independence are unverified. Existing content review is incomplete.
- Reason for missing information: Unique trials/people, individual repeats/synthesis correspondence and external comparison of actual independence are unverified.
- Required materials and conditions: Relationships between reports, trials, populations, repeated tests and endpoints
- Materials to obtain first: Report/registration/person/test/endpoint relationships and separate replication materials
- Further research: Proposed follow-up research distinguishing reuse of the same materials from separate harm replication; no new investigation, calculation or trial is performed here.
- Conditions for verification: Relevant original materials and analysis scope for Relationships between reports, trials, populations, repeated tests and endpoints must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Relationships between reports, trials, populations, repeated tests and endpoints and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M04 §4.6.1–4.6.2; Adaptation for harm materials is internally designed; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and internal design
- Related sources: S01, S02

### N29 · Original axes, Korean/English text, dates and corrections

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The full stored summary retains subclaim D/note, parent D34/Warning, B/S/R1/I2/E−/B0/C0, three false flags, empty override reasons, Korean/English text, 2026-08-26 and empty correction/deliberation records.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. Historical B0 quotations, registration correspondence and cross-checks are not verification, full-text reading or fulfilled conditions in this run. Absent subclaim score/status/axes and parent classification fields are not filled. Existing content review is incomplete.
- Reason for missing information: Historical B0 quotations, registration correspondence and cross-checks are not verification, full-text reading or fulfilled conditions in this run. Absent subclaim score/status/axes and parent classification fields are not filled.
- Required materials and conditions: Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records
- Materials to obtain first: Original verdict, corrected/changed text and user feedback
- Further research: Proposed update research distinguishing original material changes and production versions; no new investigation, calculation or trial has been performed.
- Conditions for verification: Relevant original materials and analysis scope for Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed
- Related sources: S01, S02

### N30 · Summary read; external material unread

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The preserved JSON summary was read for preparation, linking the bibliographies/URLs for Yu 2017 and EFSA 2018. External papers, registrations, protocols/SAP and funding/conflict disclosures remain unread and access was not attempted.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original materials are unread and existing content review is incomplete. URLs, original quotations and registration identifiers alone do not upgrade external acquisition, reading or review status. External links/clicks were not tested. Existing content review is incomplete.
- Reason for missing information: URLs, original quotations and registration identifiers alone do not upgrade external acquisition, reading or review status. External links/clicks were not tested.
- Required materials and conditions: Actual reading by material, identities/URLs and gaps in additional materials
- Materials to obtain first: Original papers/opinions, registration/plans, disclosures and user input
- Further research: Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now.
- Conditions for verification: Relevant original materials and analysis scope for Actual reading by material, identities/URLs and gaps in additional materials must be available, with unverified matters distinguished. Preserved wording is connected here; existing content review is incomplete.
- Why this condition is needed: Preparation item distinguishing Actual reading by material, identities/URLs and gaps in additional materials and connecting materials needed for the selected question with currently available materials.
- Application exceptions: Limited to the original scope of the selected high-dose capsules, population and liver-enzyme safety materials. Liver failure/death, other formulations/populations, repeated tests and syntheses are not treated as the same outcome/independent replication. No new verdict, incidence/confidence interval or instructions for intake, monitoring, interruption, rechallenge or treatment are created.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: S01, S02

## Evidence and sources

### S01

Yu Z et al. 2017 MGTT safety analysis

[PubMed](https://pubmed.ncbi.nlm.nih.gov/28765194/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 26 women (5.1%), OR 7.0 (95% CI 2.4-20.3), P=.0002; ALT +5.4 U/L, AST +3.8 U/L. The selected liver-enzyme safety D/note is distinguished from other continuous/all-ALT/grade and interruption/re-exposure accounts. OR is not changed into RR/new incidence, and this does not establish increased liver failure/death.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Yu 2017 reports MGTT’s prespecified liver-enzyme safety analysis. The original efficacy primary endpoint, breast density, is distinguished from CTCAE grade 2-or-higher safety outcomes. Original descriptions are retained separately: 1,021 postmenopausal women aged 50-70 with normal baseline enzymes (513/508), three missing baselines and 51 withdrawals before the first monthly test; no new randomized total or exclusion sum is calculated. About 843 mg EGCG daily/12 months, 26 women (5.1%)/OR 7.0 (2.4-20.3)/P=.0002, continuous ALT/AST, all ALT events 53 (6.7%) versus 4 (0.7%), grade-specific cases/peaks and interruption/re-exposure responses concern different original measures/units. Event/person/repeated-measure details, endpoint-specific denominators and original analyses are unverified. Report/material slots are not unique clinical trials, participants or independent-replication totals; no new sums or independence certification are made. S02 EFSA ANS Panel 2018 is a scientific-opinion synthesis on green tea catechin safety preserved through a citation only, without an original evidence-list row. The stored association between at least 800 mg EGCG from extracts for at least four months and enzyme elevation is distinguished from tea/lower-dose formulations. Included trials/populations, MGTT correspondence and synthesis plan/funding details remain externally unread. It is not certified as an independent RCT/harm replication under the same conditions, and participants are not added to MGTT totals.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S02

EFSA ANS Panel. Scientific opinion on the safety of green tea catechins. EFSA Journal. 2018;16:5239.

[Official source](https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5239)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: The preserved conclusion associates long-term use of at least 800 mg EGCG from extracts with liver-enzyme elevation. EFSA’s at least 800 mg/at least four months, tea/extracts of 316 mg or less and MGTT’s 843 mg/12 months concern different exposure/material scopes. Included materials, actual denominators/independence and method/funding details remain unread; no universal safe dose is created.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Yu 2017 reports MGTT’s prespecified liver-enzyme safety analysis. The original efficacy primary endpoint, breast density, is distinguished from CTCAE grade 2-or-higher safety outcomes. Original descriptions are retained separately: 1,021 postmenopausal women aged 50-70 with normal baseline enzymes (513/508), three missing baselines and 51 withdrawals before the first monthly test; no new randomized total or exclusion sum is calculated. About 843 mg EGCG daily/12 months, 26 women (5.1%)/OR 7.0 (2.4-20.3)/P=.0002, continuous ALT/AST, all ALT events 53 (6.7%) versus 4 (0.7%), grade-specific cases/peaks and interruption/re-exposure responses concern different original measures/units. Event/person/repeated-measure details, endpoint-specific denominators and original analyses are unverified. Report/material slots are not unique clinical trials, participants or independent-replication totals; no new sums or independence certification are made. S02 EFSA ANS Panel 2018 is a scientific-opinion synthesis on green tea catechin safety preserved through a citation only, without an original evidence-list row. The stored association between at least 800 mg EGCG from extracts for at least four months and enzyme elevation is distinguished from tea/lower-dose formulations. Included trials/populations, MGTT correspondence and synthesis plan/funding details remain externally unread. It is not certified as an independent RCT/harm replication under the same conditions, and participants are not added to MGTT totals.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## 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, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- 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 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- 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 · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- 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. · Preserved method HTML copies; no current method-content re-review or official tool execution
- 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 rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
- Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
- Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
- Review incomplete: Existing content review remains incomplete.
- Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
- Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
- Not applicable: Not used as a substitute for an evidence gap.
- Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
- Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

## Change history

2026-10-12 · Public page/materials 1.0. The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.