{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Surgical-mask recommendation × Infection in the wearer at one month",
  "language": "en",
  "translation_date": "2026-10-14",
  "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": "Evidence condition",
      "question": "Selected wearer question and original grade",
      "needed": "Existing question, grade/note, parent values and separate transmission question",
      "role": "Required",
      "role_reason": "Applicability item distinguishing existing question, grade/note, parent values and separate transmission question and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for existing question, grade/note, parent values and separate transmission question should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal for later research specifying the wearer endpoint/timepoint; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "2020 Denmark and community setting",
      "needed": "Time/setting, actual population, recruitment and baseline risk",
      "role": "Required",
      "role_reason": "Applicability item distinguishing time/setting, actual population, recruitment and baseline risk and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for time/setting, actual population, recruitment and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal for later comparative research specifying the setting/population; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Recommendation, 50 masks and instructions",
      "needed": "Assigned recommendation/support versus actual wearing and product effects",
      "role": "Required",
      "role_reason": "Applicability item distinguishing assigned recommendation/support versus actual wearing and product effects and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for assigned recommendation/support versus actual wearing and product effects should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal for later research distinguishing recommendation/support from actual wearing; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Actual wearing and self-reported adherence",
      "needed": "46/47/7% categories/periods, measurement and exposure",
      "role": "Required",
      "role_reason": "Applicability item distinguishing 46/47/7% categories/periods, measurement and exposure and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for 46/47/7% categories/periods, measurement and exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M03 §3.2.4; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently 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": "Proposal specifying differences between reported adherence and actual exposure; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Recommendation effects and adherence-based analysis",
      "needed": "Assigned recommendation versus actual-wearer/full-adherence effects",
      "role": "Required",
      "role_reason": "Applicability item distinguishing assigned recommendation versus actual-wearer/full-adherence effects and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for assigned recommendation versus actual-wearer/full-adherence effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M04 §4.6.3; 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": "Proposal distinguishing assignment strategies and actual-exposure estimands; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Control and concurrent public-health measures",
      "needed": "Actual measures and contact/exposure differences across groups",
      "role": "Required",
      "role_reason": "Applicability item distinguishing actual measures and contact/exposure differences across groups and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for actual measures and contact/exposure differences across groups should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal specifying actual comparisons/concurrent conditions; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Randomization and lack of masking",
      "needed": "Design label and scope of allocation/measurement/analysis procedures",
      "role": "Required",
      "role_reason": "Applicability item distinguishing design label and scope of allocation/measurement/analysis procedures and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for design label and scope of allocation/measurement/analysis procedures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; 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": "Proposal disclosing allocation and outcome measurement/adjudication; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Composite infection ascertainment",
      "needed": "Antibody testing, PCR, hospital diagnosis and component/adjudication rules",
      "role": "Required",
      "role_reason": "Applicability item distinguishing antibody testing, PCR, hospital diagnosis and component/adjudication rules and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for antibody testing, PCR, hospital diagnosis and component/adjudication rules should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; 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": "Proposal distinguishing component ascertainment from the composite endpoint; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Testing time, baseline infection and missingness",
      "needed": "Correspondence of one-month infection with tests/baseline/assessment windows",
      "role": "Required",
      "role_reason": "Applicability item distinguishing correspondence of one-month infection with tests/baseline/assessment windows and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for correspondence of one-month infection with tests/baseline/assessment windows should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently 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": "Proposal specifying testing/baseline conditions and infection-adjudication timing; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "One month and duration/exposure scope",
      "needed": "Original period, actual observation/wearing and long-term/other-epidemic boundaries",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original period, actual observation/wearing and long-term/other-epidemic boundaries and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for original period, actual observation/wearing and long-term/other-epidemic boundaries should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "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 and 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": "Proposal distinguishing timepoint/duration and setting-specific applicability; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Original events and complete-case denominators",
      "needed": "42/2,392 and 53/2,470 versus people/test units",
      "role": "Required",
      "role_reason": "Applicability item distinguishing 42/2,392 and 53/2,470 versus people/test units and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for 42/2,392 and 53/2,470 versus people/test units should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal reporting people/events/tests and denominators separately; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Original absolute difference, CI and P",
      "needed": "Original absolute effect/CI versus rounded proportions and models",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original absolute effect/CI versus rounded proportions and models and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for original absolute effect/CI versus rounded proportions and models should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; 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": "Proposal for later research disclosing effect measures and precision; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "OR, CI and separate P",
      "needed": "Original OR/CI versus the different absolute-difference estimand",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original OR/CI versus the different absolute-difference estimand and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for original OR/CI versus the different absolute-difference estimand should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; 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": "Proposal reporting effect measures/tests separately; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Nonsignificance, wide CI and importance",
      "needed": "Null verdict versus possible benefit/harm, exactly zero and equivalence",
      "role": "Required",
      "role_reason": "Applicability item distinguishing null verdict versus possible benefit/harm, exactly zero and equivalence and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for null verdict versus possible benefit/harm, exactly zero and equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries",
      "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 specifying effects/precision and question scope; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "6,024 randomized and 4,862 complete cases",
      "needed": "Randomized/complete-case populations and group denominators",
      "role": "Required",
      "role_reason": "Applicability item distinguishing randomized/complete-case populations and group denominators and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for randomized/complete-case populations and group denominators should be available, with unverified matters distinguishable. Preserved wording is connected 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",
      "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 distinguishing allocated/observed/analyzed denominators; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "19.3% missingness and dropout",
      "needed": "Group missingness/deviations, testing/reporting and outcome effects",
      "role": "Required",
      "role_reason": "Applicability item distinguishing group missingness/deviations, testing/reporting and outcome effects and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for group missingness/deviations, testing/reporting and outcome effects should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal reporting effects of missingness and observation selection; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Complete-case estimands and within/between-group comparisons",
      "needed": "Analysis populations/models, assigned effects and observation selection",
      "role": "Required",
      "role_reason": "Applicability item distinguishing analysis populations/models, assigned effects and observation selection and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for analysis populations/models, assigned effects and observation selection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently 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": "Proposal distinguishing assignment, observation and actual-exposure estimands; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Registration, retrospective dates and plans",
      "needed": "Preserved NCT/dates and prespecified endpoint/analysis contracts",
      "role": "Required",
      "role_reason": "Applicability item distinguishing preserved NCT/dates and prespecified endpoint/analysis contracts and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for preserved NCT/dates and prespecified endpoint/analysis contracts should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal linking and disclosing plan/registration timing and actual analyses; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Primary/secondary outcomes and multiplicity",
      "needed": "Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy",
      "role": "Required",
      "role_reason": "Applicability item distinguishing wearer primary endpoint, test components and effect-measure/other-outcome hierarchy and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for wearer primary endpoint, test components and effect-measure/other-outcome hierarchy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently 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": "Proposal separating primary, component and secondary outcomes; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Transmission to others and mandates were unmeasured",
      "needed": "Wearer protection versus source control, policy and setting",
      "role": "Required",
      "role_reason": "Applicability item distinguishing wearer protection versus source control, policy and setting and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for wearer protection versus source control, policy and setting should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 on clarifying questions; detailed separation rules are independently designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are independently 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": "Proposal for later research separating wearer/others/policy questions; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Concurrent measures, exposure and lifestyle",
      "needed": "Group concurrent prevention/exposure, diseases/medications and contacts",
      "role": "Required",
      "role_reason": "Applicability item distinguishing group concurrent prevention/exposure, diseases/medications and contacts and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for group concurrent prevention/exposure, diseases/medications and contacts should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal distinguishing concurrent conditions from recommendation/wearing effects; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Salling funding and Rigshospitalet",
      "needed": "Support/sponsorship, roles and independence",
      "role": "Required",
      "role_reason": "Applicability item distinguishing support/sponsorship, roles and independence and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for support/sponsorship, roles and independence should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal for later research disclosing support/research roles; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Study mask supply and donated support",
      "needed": "Study supply versus manufacturer support/products and actual receipt",
      "role": "Required",
      "role_reason": "Applicability item distinguishing study supply versus manufacturer support/products and actual receipt and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for study supply versus manufacturer support/products and actual receipt should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions; the official method sections used in the pilot do not validate every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are independently designed; M03 §3.2.3, M08 §8.2.2–8.2.3; 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": "Proposal separating study supply from manufacturer support; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Medical writing, publication costs and author relationships",
      "needed": "Unverified support items and author/analysis roles",
      "role": "Required",
      "role_reason": "Applicability item distinguishing unverified support items and author/analysis roles and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for unverified support items and author/analysis roles should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal disclosing support items separately; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "One trial, bibliographic years and sibling sheets",
      "needed": "Evidence-list 2020, citation-list 2021 and the same DANMASK relationship",
      "role": "Required",
      "role_reason": "Applicability item distinguishing evidence-list 2020, citation-list 2021 and the same DANMASK relationship and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for evidence-list 2020, citation-list 2021 and the same DANMASK relationship should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; 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": "Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Generalization across duration, setting and products",
      "needed": "Original recommendation/setting versus other situations and long-term effects",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original recommendation/setting versus other situations and long-term effects and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for original recommendation/setting versus other situations and long-term effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation 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": "Proposal distinguishing question/situation/duration applicability; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Unknown safety and unquantified harms",
      "needed": "Discomfort/skin irritation and harms collection/denominator/follow-up scope",
      "role": "Supplementary",
      "role_reason": "Applicability item distinguishing discomfort/skin irritation and harms collection/denominator/follow-up scope and connecting materials needed for the selected question with current materials.",
      "application_exception": "Supplement the selected subclaim’s safety-material gaps. Wearer-infection results or parent safety wording do not establish safety or create harms rates or new usage instructions.",
      "criterion": "Corresponding original materials and analysis scope for discomfort/skin irritation and harms collection/denominator/follow-up scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; 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 research specifying harms collection/scope; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Original values, both languages, dates, corrections and history",
      "needed": "Parent/subclaim scores/axes versus historical verification/dates",
      "role": "Required",
      "role_reason": "Applicability item distinguishing parent/subclaim scores/axes versus historical verification/dates and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for parent/subclaim scores/axes versus historical verification/dates should be available, with unverified matters distinguishable. Preserved wording is connected 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": "Proposal separating original values/history from new-material application; no new investigation, calculation or trial was performed in that production."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Actual summary reading and material links",
      "needed": "Preserved-summary reading versus external paper/registration/plan access",
      "role": "Required",
      "role_reason": "Applicability item distinguishing preserved-summary reading versus external paper/registration/plan access and connecting materials needed for the selected question with current 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": "Corresponding original materials and analysis scope for preserved-summary reading versus external paper/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected 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."
    }
  ]
}