{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Low-dose penicillin × Reduced first recurrence during 12 months of treatment",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
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    {
      "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"
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    {
      "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."
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  "requirements": [
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      "question_type": "Evidence condition",
      "question": "Selected first recurrence during treatment and original grade",
      "needed": "Original wording/grade/note versus parent values and post-treatment results",
      "role": "Required",
      "role_reason": "An application item distinguishing Original wording/grade/note versus parent values and post-treatment results to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original wording/grade/note versus parent values and post-treatment results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom 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 comparative research specifying first-recurrence endpoints by period; no new investigation, calculation or trial was performed in this production."
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    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Recurrence risk, eligibility and population",
      "needed": "Recent recurrence, age/eligibility, baseline risk and applicability",
      "role": "Required",
      "role_reason": "An application item distinguishing Recent recurrence, age/eligibility, baseline risk and applicability to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Recent recurrence, age/eligibility, baseline risk and applicability should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details 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 specifying recurrence risk and population scope; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Penicillin V study exposure",
      "needed": "Original antibiotic, dose/frequency/duration and formulation identity",
      "role": "Required",
      "role_reason": "An application item distinguishing Original antibiotic, dose/frequency/duration and formulation identity to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original antibiotic, dose/frequency/duration and formulation identity should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "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 separating drug/duration from applicability; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Placebo and comparison specifications",
      "needed": "Actual placebo composition/sensory features, contact and concurrent treatment matching",
      "role": "Required",
      "role_reason": "An application item distinguishing Actual placebo composition/sensory features, contact and concurrent treatment matching to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Actual placebo composition/sensory features, contact and concurrent treatment matching should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "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 trial specifying actual comparison conditions; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Central pharmacy and allocation concealment",
      "needed": "Original allocation/drug-supply descriptions versus actual original-text verification",
      "role": "Required",
      "role_reason": "An application item distinguishing Original allocation/drug-supply descriptions versus actual original-text verification to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original allocation/drug-supply descriptions versus actual original-text verification should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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 follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Double masking and assessors",
      "needed": "Actual masking/maintenance of participants, clinicians and analysts",
      "role": "Required",
      "role_reason": "An application item distinguishing Actual masking/maintenance of participants, clinicians and analysts to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Actual masking/maintenance of participants, clinicians and analysts should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; 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 specifying endpoint adjudication and masking; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Clinician-confirmed recurrence definition",
      "needed": "Reporting, diagnostic confirmation, first/all recurrences and site definitions",
      "role": "Required",
      "role_reason": "An application item distinguishing Reporting, diagnostic confirmation, first/all recurrences and site definitions to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Reporting, diagnostic confirmation, first/all recurrences and site definitions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "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 research specifying first clinical recurrence definitions/adjudication; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Time to first recurrence",
      "needed": "Prespecified primary time endpoint versus proportions/total events",
      "role": "Required",
      "role_reason": "An application item distinguishing Prespecified primary time endpoint versus proportions/total events to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Prespecified primary time endpoint versus proportions/total events should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application",
      "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 endpoints from period proportions/repeated events; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "During treatment: 30/136 and 51/138",
      "needed": "Original first-recurrence people/denominators and 22%/37%",
      "role": "Required",
      "role_reason": "An application item distinguishing Original first-recurrence people/denominators and 22%/37% to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original first-recurrence people/denominators and 22%/37% should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "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 research reporting people/event/time denominators separately; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "HR 0.55·CI·P",
      "needed": "Original first-recurrence time effect/CI versus proportions",
      "role": "Required",
      "role_reason": "An application item distinguishing Original first-recurrence time effect/CI versus proportions to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original first-recurrence time effect/CI versus proportions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own 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 reporting time effects and uncertainty; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Original absolute difference and NNT",
      "needed": "Original absolute difference/NNT and period/analysis/estimation specifications",
      "role": "Required",
      "role_reason": "An application item distinguishing Original absolute difference/NNT and period/analysis/estimation specifications to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original absolute difference/NNT and period/analysis/estimation specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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 follow-up research separating absolute/time effects and calculation specifications; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "27% after stopping and persistence",
      "needed": "During-treatment versus post-treatment results, denominators/estimation",
      "role": "Required",
      "role_reason": "An application item distinguishing During-treatment versus post-treatment results, denominators/estimation to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for During-treatment versus post-treatment results, denominators/estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details 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 follow-up research distinguishing persistence during/after treatment; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "12 months, exposure, adherence/discontinuation",
      "needed": "Planned treatment duration versus actual exposure/stopping/changes",
      "role": "Required",
      "role_reason": "An application item distinguishing Planned treatment duration versus actual exposure/stopping/changes to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Planned treatment duration versus actual exposure/stopping/changes should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations 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 research distinguishing planned/actual exposure and period-specific effects; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "274 participants, 28 hospitals and 136/138",
      "needed": "Recruitment/randomization denominators versus endpoint observation/at-risk populations",
      "role": "Required",
      "role_reason": "An application item distinguishing Recruitment/randomization denominators versus endpoint observation/at-risk populations to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Recruitment/randomization denominators versus endpoint observation/at-risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "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 research distinguishing recruitment/observation/risk denominators; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "ITT principle and actual analysis populations",
      "needed": "Original ITT versus inclusion/exclusion, estimation populations and censoring specifications",
      "role": "Required",
      "role_reason": "An application item distinguishing Original ITT versus inclusion/exclusion, estimation populations and censoring specifications to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original ITT versus inclusion/exclusion, estimation populations and censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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 research separately disclosing assignment/exposure/observation analyses; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Missingness, withdrawals and observation time",
      "needed": "Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation",
      "role": "Required",
      "role_reason": "An application item distinguishing Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application",
      "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 research reporting follow-up and its effects on first-event estimation; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Two registrations and prespecified plans",
      "needed": "ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions",
      "role": "Required",
      "role_reason": "An application item distinguishing ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom 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 research linking and disclosing prespecified plans and actual period-specific analyses; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Primary/secondary outcomes, periods and multiple tests",
      "needed": "First-recurrence primary endpoint versus other events/periods/subgroup hierarchy",
      "role": "Required",
      "role_reason": "An application item distinguishing First-recurrence primary endpoint versus other events/periods/subgroup hierarchy to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for First-recurrence primary endpoint versus other events/periods/subgroup hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "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 research distinguishing primary from period-specific/secondary results; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Concurrent treatment and recurrence-risk management",
      "needed": "Concurrent medications/conditions/lifestyle management and contact by arm",
      "role": "Required",
      "role_reason": "An application item distinguishing Concurrent medications/conditions/lifestyle management and contact by arm to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Concurrent medications/conditions/lifestyle management and contact by arm should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own 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 concurrent management from study-drug effects; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "PATCH II companion report and directness",
      "needed": "Separate-cohort results versus PATCH I specifications",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate-cohort results versus PATCH I specifications to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Separate-cohort results versus PATCH I specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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 follow-up research specifying separate cohorts/specifications; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Two estimates, nonsignificance and conflict scope",
      "needed": "PATCH II CI and the original verdict’s relationship interpretation",
      "role": "Required",
      "role_reason": "An application item distinguishing PATCH II CI and the original verdict’s relationship interpretation to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for PATCH II CI and the original verdict’s relationship interpretation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "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 research distinguishing matching specifications from result relationships; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Reports, cohorts, network and independence",
      "needed": "PATCH I/II separate cohorts versus the same network",
      "role": "Required",
      "role_reason": "An application item distinguishing PATCH I/II separate cohorts versus the same network to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for PATCH I/II separate cohorts versus the same network should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "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": "Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Action Medical Research funding",
      "needed": "Nonprofit funding versus support roles/other relationships",
      "role": "Required",
      "role_reason": "An application item distinguishing Nonprofit funding versus support roles/other relationships to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Nonprofit funding versus support roles/other relationships should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "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 disclosing support roles; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Nottingham sponsorship and pharmaceutical support",
      "needed": "Research sponsor and verification of cash/product/analysis support",
      "role": "Required",
      "role_reason": "An application item distinguishing Research sponsor and verification of cash/product/analysis support to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Research sponsor and verification of cash/product/analysis support should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains 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 research separately disclosing research roles and item-specific support; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Adverse-event reporters and P",
      "needed": "People versus event counts/denominators and nonsignificance versus safety",
      "role": "Supplementary",
      "role_reason": "An application item distinguishing People versus event counts/denominators and nonsignificance versus safety to connect materials needed for the selected question with available materials.",
      "application_exception": "Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.",
      "criterion": "Relevant originals and analysis scope for People versus event counts/denominators and nonsignificance versus safety should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "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 harm research distinguishing people/events and uncertainty; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Allergy, gastrointestinal and resistance gaps",
      "needed": "Parent caution wording versus actual harm/resistance measurement",
      "role": "Supplementary",
      "role_reason": "An application item distinguishing Parent caution wording versus actual harm/resistance measurement to connect materials needed for the selected question with available materials.",
      "application_exception": "Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.",
      "criterion": "Relevant originals and analysis scope for Parent caution wording versus actual harm/resistance measurement should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains 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; 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 specifying harm/resistance collection scope; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Other drugs/populations and persistent application",
      "needed": "Original recurrence risk, drug/route/duration versus long-term generalization",
      "role": "Required",
      "role_reason": "An application item distinguishing Original recurrence risk, drug/route/duration versus long-term generalization to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Original recurrence risk, drug/route/duration versus long-term generalization should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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 follow-up research distinguishing specifications/period from persistent protection; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Parent/subclaim, bilingual text and history",
      "needed": "Separate original score/axes, evidence date, corrections and verification descriptions",
      "role": "Required",
      "role_reason": "An application item distinguishing Separate original score/axes, evidence date, corrections and verification descriptions to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Separate original score/axes, evidence date, corrections and verification descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains 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 research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Actual summary reading and material links",
      "needed": "Reading preserved summaries versus external papers/two registrations/plans",
      "role": "Required",
      "role_reason": "An application item distinguishing Reading preserved summaries versus external papers/two registrations/plans to connect materials needed for the selected question with available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant originals and analysis scope for Reading preserved summaries versus external papers/two registrations/plans should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains 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": "Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production."
    }
  ]
}