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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Harm · Liver-enzyme safety materialsSelected liver-enzyme safety claim and original valuesRequired	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. S01 S02	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.	Distinguish the selected claim and original grade/note from the parent verdict, axes and values	Update research linking the original question with additional material; no new search, calculation or trial was performed here.
2	Partly verified	Full text not readStored summary read	N02 · Harm · Liver-enzyme safety materialsNormal liver enzymes and postmenopausal womenRequired	The MGTT analysis included 1,021 postmenopausal women aged 50-70 with normal baseline liver enzymes: 513 receiving extract and 508 placebo. S01	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.	Original population, baseline liver enzymes, recruitment and eligibility scope	Proposed follow-up research on population-specific applicability of harm; no new investigation, calculation or trial is performed here.
3	Partly verified	Full text not readStored summary read	N03 · Harm · Liver-enzyme safety materialsHigh-dose capsules and EGCG 843 mgRequired	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. S01	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.	Formulation, constituent exposure and product identity	Proposed follow-up research on formulation/exposure differences and applicability of harm; no new investigation, calculation or trial is performed here.
4	Partly verified	Full text not readStored summary read	N04 · Harm · Liver-enzyme safety materialsPlacebo and correspondence between groupsRequired	The double-blind placebo-controlled safety analysis populations of 513 receiving extract and 508 placebo are retained. S01	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.	Actual placebo/coexisting conditions compared with the study exposure	Proposed follow-up research distinguishing the comparison from actual exposure; no new investigation, calculation or trial is performed here.
5	Partly verified	Full text not readStored summary read	N05 · Harm · Liver-enzyme safety materialsTwelve months and observation timeRequired	The 12 months of the MGTT safety analysis are retained. Individual exposure/testing/interruption and evidence for other durations in EFSA are distinguished. S01	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.	Exposure, testing, interruption and actual follow-up windows	Proposed follow-up research distinguishing time and cumulative/repeated harm; no new investigation, calculation or trial is performed here.
6	Partly verified	Full text not readStored summary read	N06 · Harm · Liver-enzyme safety materialsRandomizing pharmacy and permuted blocksRequired	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. S01	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.	Original randomization/concealment description and actual materials	Proposed follow-up research on randomization and the relationship between comparison groups; no new investigation, calculation or trial is performed here.
7	Partly verified	Full text not readStored summary read	N07 · Harm · Liver-enzyme safety materialsMasking of researchers and laboratory staffRequired	The original account of double masking is retained: study staff, participants, laboratory personnel and those assessing outcomes were unaware of assignment. S01	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.	Masking and implementation by measurement/assessment role	Proposed follow-up research on measurement/assessment bias and harm verification; no new investigation, calculation or trial is performed here.
8	Partly verified	Full text not readStored summary read	N08 · Harm · Liver-enzyme safety materialsPrespecified safety analysis and breast densityRequired	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. S01	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.	Relationship between the trial efficacy primary endpoint and the selected safety analysis	Proposed follow-up research distinguishing plans from safety reporting; no new investigation, calculation or trial is performed here.
9	Partly verified	Full text not readStored summary read	N09 · Harm · Liver-enzyme safety materialsDefinition of CTCAE grade 2 or higherRequired	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. S01	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.	Selected liver-function abnormality definition, components, assessment and event units	Proposed follow-up research on differences arising from harm-endpoint/event definitions; no new investigation, calculation or trial is performed here.
10	Partly verified	Full text not readStored summary read	N10 · Harm · Liver-enzyme safety materialsTwenty-six women, 5.1% and denominatorsRequired	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. S01	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.	People, denominators and group correspondence for selected moderate-or-worse abnormalities	Proposed follow-up research using the same harm endpoint and denominator definitions; no new investigation, calculation or trial is performed here.
11	Partly verified	Full text not readStored summary read	N11 · Harm · Liver-enzyme safety materialsOR7.0·CI·PRequired	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. S01	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.	Original comparative estimate, precision and model	Proposed follow-up research on harm estimates and uncertainty; no new investigation, calculation or trial is performed here.
12	Partly verified	Full text not readStored summary read	N12 · Harm · Liver-enzyme safety materialsOriginal between-group ALT and AST valuesRequired	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. S01	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.	Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence	Proposed follow-up research distinguishing continuous enzymes from threshold events; no new investigation, calculation or trial is performed here.
13	Partly verified	Full text not readStored summary read	N13 · Harm · Liver-enzyme safety materialsTotal ALT events: 53 versus 4Required	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. S01	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.	Definition, units and denominators of all ALT-elevation events	Proposed follow-up research on event units and harm components; no new investigation, calculation or trial is performed here.
14	Partly verified	Full text not readStored summary read	N14 · Harm · Liver-enzyme safety materialsSevere grades and peak ALTRequired	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. S01	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.	Relationship of grade-specific cases and peak values to the selected endpoint	Proposed follow-up research distinguishing severity from repeated outcomes in the same person; no new investigation, calculation or trial is performed here.
15	Partly verified	Full text not readStored summary read	N15 · Harm · Liver-enzyme safety materialsResponses after withdrawal and rechallengeRequired	The original account of normalization after withdrawal and renewed elevation on rechallenge is retained. This table does not instruct withdrawal or rechallenge. S01	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.	Relationship between exposure/interruption/re-exposure, changes and assessment	Proposed follow-up research on time/re-exposure responses and causal limits; no new investigation, calculation or trial is performed here.
16	Partly verified	Full text not readStored summary read	N16 · Harm · Liver-enzyme safety materialsMonthly monitoring and months 9/12Required	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. S01	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.	Original trial testing frequency and actual observations/missingness	Proposed follow-up research on monitoring frequency and detected/missed harm; no new investigation, calculation or trial is performed here.
17	Partly verified	Full text not readStored summary read	N17 · Harm · Liver-enzyme safety materialsOriginal interruption rules and safety thresholdsRequired	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. S01	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.	Distinguish trial procedure thresholds from outcome/efficacy criteria	Proposed follow-up research on how monitoring/interruption rules affected observed outcomes; no new investigation, calculation or trial is performed here.
18	Partly verified	Full text not readStored summary read	N18 · Harm · Liver-enzyme safety materials1,021 participants, three missing baselines and 51 withdrawalsRequired	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. S01	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.	Prespecified safety-analysis population, exclusions and missingness	Proposed follow-up research on selected populations and missing-data assumptions; no new investigation, calculation or trial is performed here.
19	Partly verified	Full text not readStored summary read	N19 · Harm · Liver-enzyme safety materialsRegistration NCT and historical prespecificationRequired	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. S01	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.	Registration identity, safety plans/changes and correspondence with original reports	Proposed follow-up research on prespecified plans and safety reporting; no new investigation, calculation or trial is performed here.
20	Unverified	Full text not readStored summary read	N20 · Harm · Liver-enzyme safety materialsConcurrent exposures and other causesRequired	The scope of comparison between the particular high-dose capsules and placebo is retained. S01	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.	Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes	Proposed follow-up research on coexisting factors and attribution of harm; no new investigation, calculation or trial is performed here.
21	Partly verified	Full text not readStored summary read	N21 · Harm · Liver-enzyme safety materialsNIH/NCI fundingRequired	The original description of federal NIH/NCI grant support is retained. S01	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.	Distinguish funding, roles and analysis/publication support	Proposed follow-up research on support roles and outcome reporting; no new investigation, calculation or trial is performed here.
22	Partly verified	Full text not readStored summary read	N22 · Harm · Liver-enzyme safety materialsManufacturing and quality-testing rolesRequired	The original descriptions that Corban Laboratories manufactured capsules and Taiyo International and research institutions participated in quality testing are retained. S01	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.	Individual institutions and roles in manufacturing and quality testing	Proposed follow-up research on product/institution roles and study relationships; no new investigation, calculation or trial is performed here.
23	Partly verified	Full text not readStored summary read	N23 · Harm · Liver-enzyme safety materialsUnreported manufacturer support and conflict declarationsRequired	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. S01	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.	Separate disclosures of research/analysis/medical-writing/publication funding and author relationships	Proposed follow-up research on the scope and gaps of individual support/declarations; no new investigation, calculation or trial is performed here.
24	Partly verified	Full text not readStored summary read	N24 · Harm · Liver-enzyme safety materialsEFSA scientific opinion and report relationshipsRequired	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. S02	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.	Synthesis identity, included materials and relationship to the original trial	Proposed follow-up research distinguishing syntheses from individual trials; no new investigation, calculation or trial is performed here.
25	Partly verified	Full text not readStored summary read	N25 · Harm · Liver-enzyme safety materials800 mg/four months, 316 mg and brewed teaRequired	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. S01 S02	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.	Scope of other formulations/doses, durations and observed signals	Proposed follow-up research distinguishing exposure differences and applicability of harm signals; no new investigation, calculation or trial is performed here.
26	Partly verified	Full text not readStored summary read	N26 · Harm · Liver-enzyme safety materialsOther disease populations and studies without reported abnormalitiesRequired	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. S01 S02	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.	Population, formulation, comparison and identity of contrary/same-direction evidence	Proposed follow-up research distinguishing population-specific signals from contrary evidence; no new investigation, calculation or trial is performed here.
27	Partly verified	Full text not readStored summary read	N27 · Harm · Liver-enzyme safety materialsLiver failure and death not establishedRequired	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. S01 S02	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.	Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes	Proposed follow-up research distinguishing enzyme abnormalities from severe clinical outcomes; no new investigation, calculation or trial is performed here.
28	Partly verified	Full text not readStored summary read	N28 · Harm · Liver-enzyme safety materialsSame trial, repeated testing and independenceRequired	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. S01 S02	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.	Relationships between reports, trials, populations, repeated tests and endpoints	Proposed follow-up research distinguishing reuse of the same materials from separate harm replication; no new investigation, calculation or trial is performed here.
29	Partly verified	Full text not readStored summary read	N29 · Harm · Liver-enzyme safety materialsOriginal axes, Korean/English text, dates and correctionsRequired	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. S01 S02	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.	Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records	Proposed update research distinguishing original material changes and production versions; no new investigation, calculation or trial has been performed.
30	Partly verified	Full text not readStored summary read	N30 · Harm · Liver-enzyme safety materialsSummary read; external material unreadRequired	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. S01 S02	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.	Actual reading by material, identities/URLs and gaps in additional materials	Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now.

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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 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

Evidence and sources

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

S01 · Yu Z et al. 2017 MGTT safety analysis

PubMed

Material type: Prespecified safety analysis of a double-blind placebo-controlled randomized trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Scientific opinion · Synthesis preserved through an existing citation only
Materials actually read: Summary read; external material unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

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

N01 · Selected liver-enzyme safety claim and original values

Required materials and conditions: Distinguish the selected claim and original grade/note from the parent verdict, axes and values
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.
Requirement and applicability: Required
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.
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.
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

N02 · Normal liver enzymes and postmenopausal women

Required materials and conditions: Original population, baseline liver enzymes, recruitment and eligibility scope
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.
Requirement and applicability: Required
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.
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.
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

N03 · High-dose capsules and EGCG 843 mg

Required materials and conditions: Formulation, constituent exposure and product identity
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.
Requirement and applicability: Required
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.
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.
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

N04 · Placebo and correspondence between groups

Required materials and conditions: Actual placebo/coexisting conditions compared with the study exposure
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.
Requirement and applicability: Required
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.
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.
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

N05 · Twelve months and observation time

Required materials and conditions: Exposure, testing, interruption and actual follow-up windows
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.
Requirement and applicability: Required
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.
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.
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

N06 · Randomizing pharmacy and permuted blocks

Required materials and conditions: Original randomization/concealment description and actual materials
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.
Requirement and applicability: Required
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.
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.
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

N07 · Masking of researchers and laboratory staff

Required materials and conditions: Masking and implementation by measurement/assessment role
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.
Requirement and applicability: Required
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.
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.
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

N08 · Prespecified safety analysis and breast density

Required materials and conditions: Relationship between the trial efficacy primary endpoint and the selected safety analysis
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.
Requirement and applicability: Required
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.
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.
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

N09 · Definition of CTCAE grade 2 or higher

Required materials and conditions: Selected liver-function abnormality definition, components, assessment and event units
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.
Requirement and applicability: Required
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.
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.
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

N10 · Twenty-six women, 5.1% and denominators

Required materials and conditions: People, denominators and group correspondence for selected moderate-or-worse abnormalities
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.
Requirement and applicability: Required
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.
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.
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

N11 · OR7.0·CI·P

Required materials and conditions: Original comparative estimate, precision and model
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.
Requirement and applicability: Required
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.
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.
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

N12 · Original between-group ALT and AST values

Required materials and conditions: Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence
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.
Requirement and applicability: Required
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.
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.
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

N13 · Total ALT events: 53 versus 4

Required materials and conditions: Definition, units and denominators of all ALT-elevation events
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.
Requirement and applicability: Required
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.
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.
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

N14 · Severe grades and peak ALT

Required materials and conditions: Relationship of grade-specific cases and peak values to the selected endpoint
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.
Requirement and applicability: Required
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.
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.
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

N15 · Responses after withdrawal and rechallenge

Required materials and conditions: Relationship between exposure/interruption/re-exposure, changes and assessment
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.
Requirement and applicability: Required
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.
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.
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

N16 · Monthly monitoring and months 9/12

Required materials and conditions: Original trial testing frequency and actual observations/missingness
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.
Requirement and applicability: Required
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.
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.
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

N17 · Original interruption rules and safety thresholds

Required materials and conditions: Distinguish trial procedure thresholds from outcome/efficacy criteria
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.
Requirement and applicability: Required
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.
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.
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

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

Required materials and conditions: Prespecified safety-analysis population, exclusions and missingness
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.
Requirement and applicability: Required
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.
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.
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

N19 · Registration NCT and historical prespecification

Required materials and conditions: Registration identity, safety plans/changes and correspondence with original reports
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.
Requirement and applicability: Required
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.
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.
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

N20 · Concurrent exposures and other causes

Required materials and conditions: Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes
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.
Requirement and applicability: Required
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.
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.
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

N21 · NIH/NCI funding

Required materials and conditions: Distinguish funding, roles and analysis/publication support
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.
Requirement and applicability: Required
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.
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.
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

N22 · Manufacturing and quality-testing roles

Required materials and conditions: Individual institutions and roles in manufacturing and quality testing
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.
Requirement and applicability: Required
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.
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.
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

N23 · Unreported manufacturer support and conflict declarations

Required materials and conditions: Separate disclosures of research/analysis/medical-writing/publication funding and author relationships
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.
Requirement and applicability: Required
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.
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.
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

N24 · EFSA scientific opinion and report relationships

Required materials and conditions: Synthesis identity, included materials and relationship to the original trial
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.
Requirement and applicability: Required
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.
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.
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

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

Required materials and conditions: Scope of other formulations/doses, durations and observed signals
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.
Requirement and applicability: Required
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.
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.
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

N26 · Other disease populations and studies without reported abnormalities

Required materials and conditions: Population, formulation, comparison and identity of contrary/same-direction evidence
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.
Requirement and applicability: Required
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.
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.
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

N27 · Liver failure and death not established

Required materials and conditions: Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes
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.
Requirement and applicability: Required
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.
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.
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

N28 · Same trial, repeated testing and independence

Required materials and conditions: Relationships between reports, trials, populations, repeated tests and endpoints
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.
Requirement and applicability: Required
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.
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.
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

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

Required materials and conditions: Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records
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.
Requirement and applicability: Required
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.
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.
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

N30 · Summary read; external material unread

Required materials and conditions: Actual reading by material, identities/URLs and gaps in additional materials
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.
Requirement and applicability: Required
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.
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.
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

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved 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/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Selected liver-enzyme safety claim and original values

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The MGTT analysis included 1,021 postmenopausal women aged 50-70 with normal baseline liver enzymes: 513 receiving extract and 508 placebo.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The double-blind placebo-controlled safety analysis populations of 513 receiving extract and 508 placebo are retained.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The original account of double masking is retained: study staff, participants, laboratory personnel and those assessing outcomes were unaware of assignment.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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N13 · Total ALT events: 53 versus 4

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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N15 · Responses after withdrawal and rechallenge

Current findings: The original account of normalization after withdrawal and renewed elevation on rechallenge is retained. This table does not instruct withdrawal or rechallenge.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The scope of comparison between the particular high-dose capsules and placebo is retained.
Verification status: Unverified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The original description of federal NIH/NCI grant support is retained.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

Current findings: The original descriptions that Corban Laboratories manufactured capsules and Taiyo International and research institutions participated in quality testing are retained.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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N26 · Other disease populations and studies without reported abnormalities

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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N27 · Liver failure and death not established

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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N28 · Same trial, repeated testing and independence

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
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.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
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.
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