{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "High-dose green tea extract capsules · Original findings not supporting liver-enzyme safety",
  "language": "en",
  "translation_date": "2026-10-12",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "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"
    },
    {
      "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",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "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"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "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"
    }
  ],
  "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.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}