{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2962-s0",
  "verdict_number": "2962",
  "title": "High-dose green tea extract capsules · Original findings not supporting liver-enzyme safety",
  "view_version": "1.0",
  "view_created_date": "2026-10-12",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "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.",
    "intervention": "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.",
    "endpoint": "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.",
    "excluded_extensions": [
      "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"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Selected liver-enzyme safety claim and original values",
      "needed": "Distinguish the selected claim and original grade/note from the parent verdict, axes and values",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update research linking the original question with additional material; no new search, calculation or trial was performed here.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Subclaim score, status and axes are absent; parent values are not used to fill them. No new efficacy or harm grade is assigned.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Selected subclaim and parent verdict/harm-scope materials"
    },
    {
      "item_id": "N02",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Normal liver enzymes and postmenopausal women",
      "needed": "Original population, baseline liver enzymes, recruitment and eligibility scope",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on population-specific applicability of harm; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The MGTT analysis included 1,021 postmenopausal women aged 50-70 with normal baseline liver enzymes: 513 receiving extract and 508 placebo.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Recruitment/eligibility, baseline characteristics and observed-population materials"
    },
    {
      "item_id": "N03",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "High-dose capsules and EGCG 843 mg",
      "needed": "Formulation, constituent exposure and product identity",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Formulation, constituent exposure and product identity and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on formulation/exposure differences and applicability of harm; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Full composition, caffeine/co-ingredients, batches, individual actual exposure and original quality/adherence data are unverified. No new conversion or intake method is created.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Product identity, constituents/batches, actual exposure and quality materials"
    },
    {
      "item_id": "N04",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Placebo and correspondence between groups",
      "needed": "Actual placebo/coexisting conditions compared with the study exposure",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing the comparison from actual exposure; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The double-blind placebo-controlled safety analysis populations of 513 receiving extract and 508 placebo are retained.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Placebo, group exposure/adherence and coexisting-condition materials"
    },
    {
      "item_id": "N05",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Twelve months and observation time",
      "needed": "Exposure, testing, interruption and actual follow-up windows",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Exposure, testing, interruption and actual follow-up windows and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing time and cumulative/repeated harm; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The 12 months of the MGTT safety analysis are retained. Individual exposure/testing/interruption and evidence for other durations in EFSA are distinguished.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Individual start/interruption, actual dosing/testing windows, withdrawal and follow-up completeness, and post-study outcomes are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual exposure, testing and interruption/follow-up timing materials"
    },
    {
      "item_id": "N06",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Randomizing pharmacy and permuted blocks",
      "needed": "Original randomization/concealment description and actual materials",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original randomization/concealment description and actual materials and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on randomization and the relationship between comparison groups; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual assignment/access permissions, concealment, change history and original records have not been read.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original assignment procedures and access/change records"
    },
    {
      "item_id": "N07",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Masking of researchers and laboratory staff",
      "needed": "Masking and implementation by measurement/assessment role",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Masking and implementation by measurement/assessment role and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on measurement/assessment bias and harm verification; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original account of double masking is retained: study staff, participants, laboratory personnel and those assessing outcomes were unaware of assignment.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual maintenance/unmasking by role, testing/assessment procedures and original materials have not been read. Absence of all measurement bias is not certified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Role-specific masking and testing/assessment records"
    },
    {
      "item_id": "N08",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Prespecified safety analysis and breast density",
      "needed": "Relationship between the trial efficacy primary endpoint and the selected safety analysis",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing plans from safety reporting; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Original registration/protocol/SAP, safety hierarchy/multiplicity and change-history details have not been read.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original efficacy/safety hierarchy and analysis-plan materials"
    },
    {
      "item_id": "N09",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Definition of CTCAE grade 2 or higher",
      "needed": "Selected liver-function abnormality definition, components, assessment and event units",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on differences arising from harm-endpoint/event definitions; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "The CTCAE version, test-specific thresholds/components, repeated/peak measurements, event assessment and duplicate handling are unverified in original materials.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original definitions, tests/grades and assessment/duplicate-handling materials"
    },
    {
      "item_id": "N10",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Twenty-six women, 5.1% and denominators",
      "needed": "People, denominators and group correspondence for selected moderate-or-worse abnormalities",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research using the same harm endpoint and denominator definitions; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Comparator events for the selected endpoint, actual observed denominators/missingness and repeated/component correspondence are unverified. No new incidence or event total is calculated.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group-specific people/denominators and observation/event data for the selected endpoint"
    },
    {
      "item_id": "N11",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "OR7.0·CI·P",
      "needed": "Original comparative estimate, precision and model",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original comparative estimate, precision and model and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on harm estimates and uncertainty; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "The model, adjustments/group data, exact outputs and sensitivity analyses have not been read. No new RR, NNT, effect or confidence interval is calculated.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original analysis and exact outputs for the selected comparison"
    },
    {
      "item_id": "N12",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Original between-group ALT and AST values",
      "needed": "Distinguish continuous liver-enzyme outcomes from selected abnormality occurrence",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing continuous enzymes from threshold events; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Continuous-outcome estimate, time, model and observed-population materials"
    },
    {
      "item_id": "N13",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Total ALT events: 53 versus 4",
      "needed": "Definition, units and denominators of all ALT-elevation events",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on event units and harm components; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "All-ALT definitions, person/event units and denominator/repeated-measure materials"
    },
    {
      "item_id": "N14",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Severe grades and peak ALT",
      "needed": "Relationship of grade-specific cases and peak values to the selected endpoint",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing severity from repeated outcomes in the same person; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Grade-specific people/events, assessment/peak times, overlap and correspondence with the selected 26 women/all ALT events are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Grade-specific cases, timing, overlap and endpoint correspondence materials"
    },
    {
      "item_id": "N15",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Responses after withdrawal and rechallenge",
      "needed": "Relationship between exposure/interruption/re-exposure, changes and assessment",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on time/re-exposure responses and causal limits; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original account of normalization after withdrawal and renewed elevation on rechallenge is retained. This table does not instruct withdrawal or rechallenge.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Numbers of people, timing, exposure quantities, other causes, selection for rechallenge and individual case/comparator details have not been read.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual exposure/testing, interruption/re-exposure and relatedness-assessment materials"
    },
    {
      "item_id": "N16",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Monthly monitoring and months 9/12",
      "needed": "Original trial testing frequency and actual observations/missingness",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Original trial testing frequency and actual observations/missingness and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on monitoring frequency and detected/missed harm; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Actual individual testing, missing tests, additional assessment after abnormalities and monitoring differences between groups are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual testing schedules and missing/additional-assessment records"
    },
    {
      "item_id": "N17",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Original interruption rules and safety thresholds",
      "needed": "Distinguish trial procedure thresholds from outcome/efficacy criteria",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinguish trial procedure thresholds from outcome/efficacy criteria and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on how monitoring/interruption rules affected observed outcomes; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "The original plan, actual implementation/deviations, related assessments and original test values have not been read. No prescribing/intake-change instructions are created.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original trial plans, actual procedure implementation and event materials"
    },
    {
      "item_id": "N18",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "1,021 participants, three missing baselines and 51 withdrawals",
      "needed": "Prespecified safety-analysis population, exclusions and missingness",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Prespecified safety-analysis population, exclusions and missingness and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on selected populations and missing-data assumptions; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Group-specific exclusions, missing baseline/follow-up tests, actual observed flow, original full recruitment and sensitivity analyses are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Full population to safety analysis to endpoint-specific observation flow, exclusions and missingness materials"
    },
    {
      "item_id": "N19",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Registration NCT and historical prespecification",
      "needed": "Registration identity, safety plans/changes and correspondence with original reports",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on prespecified plans and safety reporting; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Original registration history, protocol/SAP, plan/report timing, changes and multiplicity have not been read.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration history, protocol/SAP and report-correspondence materials"
    },
    {
      "item_id": "N20",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Concurrent exposures and other causes",
      "needed": "Distinguish concurrent group medications/products, exposures and other causes of liver-enzyme changes",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on coexisting factors and attribution of harm; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The scope of comparison between the particular high-dose capsules and placebo is retained.",
      "condition_status": "Unverified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Concurrent exposures, baseline/follow-up diseases and individual event/relatedness materials"
    },
    {
      "item_id": "N21",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "NIH/NCI funding",
      "needed": "Distinguish funding, roles and analysis/publication support",
      "role": "Required",
      "role_reason": "Preparation item distinguishing Distinguish funding, roles and analysis/publication support and connecting materials needed for the selected question with currently available materials.",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on support roles and outcome reporting; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original description of federal NIH/NCI grant support is retained.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Contracts, roles, participation in analysis/writing/publication and individual original disclosures have not been read. Public funding alone does not certify all independence.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original funding/role, contribution and publication disclosures"
    },
    {
      "item_id": "N22",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Manufacturing and quality-testing roles",
      "needed": "Individual institutions and roles in manufacturing and quality testing",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on product/institution roles and study relationships; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original descriptions that Corban Laboratories manufactured capsules and Taiyo International and research institutions participated in quality testing are retained.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Manufacturing/supply, batches/quality testing and institution-specific role materials"
    },
    {
      "item_id": "N23",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Unreported manufacturer support and conflict declarations",
      "needed": "Separate disclosures of research/analysis/medical-writing/publication funding and author relationships",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research on the scope and gaps of individual support/declarations; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original disclosures for each support type, author employment/contributions and conflicts of interest"
    },
    {
      "item_id": "N24",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "EFSA scientific opinion and report relationships",
      "needed": "Synthesis identity, included materials and relationship to the original trial",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing syntheses from individual trials; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original EFSA opinion, included materials/populations, MGTT relationships and disclosures"
    },
    {
      "item_id": "N25",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "800 mg/four months, 316 mg and brewed tea",
      "needed": "Scope of other formulations/doses, durations and observed signals",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing exposure differences and applicability of harm signals; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual materials, denominators and estimates by formulation, dose and duration"
    },
    {
      "item_id": "N26",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Other disease populations and studies without reported abnormalities",
      "needed": "Population, formulation, comparison and identity of contrary/same-direction evidence",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing population-specific signals from contrary evidence; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Each study/population, exposure and harm material mentioned in the original account"
    },
    {
      "item_id": "N27",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Liver failure and death not established",
      "needed": "Definitions/materials distinguishing enzyme abnormalities from severe clinical outcomes",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing enzyme abnormalities from severe clinical outcomes; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual liver-failure/death definitions, observations/events and follow-up materials"
    },
    {
      "item_id": "N28",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Same trial, repeated testing and independence",
      "needed": "Relationships between reports, trials, populations, repeated tests and endpoints",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up research distinguishing reuse of the same materials from separate harm replication; no new investigation, calculation or trial is performed here.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "Unique trials/people, individual repeats/synthesis correspondence and external comparison of actual independence are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Report/registration/person/test/endpoint relationships and separate replication materials"
    },
    {
      "item_id": "N29",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Original axes, Korean/English text, dates and corrections",
      "needed": "Distinguish original subclaim/parent verdicts, values, evidence date and correction/history records",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed update research distinguishing original material changes and production versions; no new investigation, calculation or trial has been performed.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "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.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original verdict, corrected/changed text and user feedback"
    },
    {
      "item_id": "N30",
      "question_type": "Harm · Liver-enzyme safety materials",
      "question": "Summary read; external material unread",
      "needed": "Actual reading by material, identities/URLs and gaps in additional materials",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "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.",
      "condition_status": "Partly verified",
      "status_reason": "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.",
      "missingness": "URLs, original quotations and registration identifiers alone do not upgrade external acquisition, reading or review status. External links/clicks were not tested.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original papers/opinions, registration/plans, disclosures and user input"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Yu Z et al. 2017 MGTT safety analysis",
      "url": "https://pubmed.ncbi.nlm.nih.gov/28765194/",
      "report_type": "Prespecified safety analysis of a double-blind placebo-controlled randomized trial",
      "existence": "Stored bibliography exists; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "study_family": "RG2962-MGTT-SAFETY",
      "independent_replication": null,
      "observed_result": "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.",
      "result_level": "Outcome wording in the stored summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Stored file",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
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        }
      ],
      "links": [
        {
          "label": "PubMed",
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      "source_evidence_date": "2026-08-26",
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        },
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        },
        {
          "material_type": "Statistical analysis plan",
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        },
        {
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          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        }
      ],
      "links": [
        {
          "label": "Official source",
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      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
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      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
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      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
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      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
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      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
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      "id": "M15",
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      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
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      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
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      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
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  ],
  "status_dictionary": {
    "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.",
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    "reason": "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."
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  "history": [
    {
      "date": "2026-10-12",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-12"
}