{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "DDMP lactic-acid-bacteria beverage × Moisture change at weeks 4 and 8",
  "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 intermediate-visit question and original grade",
      "needed": "Distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict",
      "role": "Required",
      "role_reason": "This item distinguishes distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that distinguishes the original question's scope at each visit. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Population, recruitment and skin condition",
      "needed": "Actual participants' ages, eligibility, dry-skin definition and recruitment conditions",
      "role": "Required",
      "role_reason": "This item distinguishes actual participants' ages, eligibility, dry-skin definition and recruitment conditions to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for actual participants' ages, eligibility, dry-skin definition and recruitment conditions must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that compares the same formulation with explicitly defined population criteria. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Identity of the study beverage",
      "needed": "DDMP content, beverage formulation, other ingredients and product identity",
      "role": "Required",
      "role_reason": "This item distinguishes DDMP content, beverage formulation, other ingredients and product identity to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for DDMP content, beverage formulation, other ingredients and product identity must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that distinguishes formulation effects from attribution to individual ingredients. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Identical-beverage control without DDMP",
      "needed": "Actual intervention-control differences and ingredient or contact matching",
      "role": "Required",
      "role_reason": "This item distinguishes actual intervention-control differences and ingredient or contact matching to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for actual intervention-control differences and ingredient or contact matching must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that clearly specifies the differences from the control. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Random allocation and concealment",
      "needed": "Sequence generation, allocation concealment and implementation",
      "role": "Required",
      "role_reason": "This item distinguishes sequence generation, allocation concealment and implementation to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for sequence generation, allocation concealment and implementation must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions 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": "Blinding and assessors",
      "needed": "Actual blinding of participants, assessors and analysts and its maintenance",
      "role": "Required",
      "role_reason": "This item distinguishes actual blinding of participants, assessors and analysts and its maintenance to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for actual blinding of participants, assessors and analysts and its maintenance must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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 result adaptation is 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": "A preserved proposal for follow-up research that specifies assessor blinding and measurement conditions. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "12-week exposure and adherence",
      "needed": "Study exposure, consumption records, group-specific adherence and withdrawal criteria",
      "role": "Required",
      "role_reason": "This item distinguishes study exposure, consumption records, group-specific adherence and withdrawal criteria to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for study exposure, consumption records, group-specific adherence and withdrawal criteria must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; 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": "A preserved proposal for follow-up research that distinguishes exposure from the analysis population. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Skin sites and measurement environment",
      "needed": "Skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit",
      "role": "Required",
      "role_reason": "This item distinguishes skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; 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": "A preserved proposal for follow-up research that specifies measurement conditions at each visit. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Baseline, units and definition of change",
      "needed": "Units and calculation definitions for absolute moisture values and changes from baseline",
      "role": "Required",
      "role_reason": "This item distinguishes units and calculation definitions for absolute moisture values and changes from baseline to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for units and calculation definitions for absolute moisture values and changes from baseline must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that reports absolute values and change estimates separately. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Moisture change at week 4",
      "needed": "Week-4 changes by group, comparison and uncertainty",
      "role": "Required",
      "role_reason": "This item distinguishes week-4 changes by group, comparison and uncertainty to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for week-4 changes by group, comparison and uncertainty must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; 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": "A preserved proposal for follow-up research that distinguishes week-4 changes from final effects. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Moisture change at week 8",
      "needed": "Week-8 changes by group, comparison and uncertainty",
      "role": "Required",
      "role_reason": "This item distinguishes week-8 changes by group, comparison and uncertainty to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for week-8 changes by group, comparison and uncertainty must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; 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": "A preserved proposal for follow-up research that distinguishes replication of intermediate changes from persistence at the final visit. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Final week-12 absolute moisture values",
      "needed": "Absolute values, units and P for the prespecified final primary endpoint",
      "role": "Required",
      "role_reason": "This item distinguishes absolute values, units and P for the prespecified final primary endpoint to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for absolute values, units and P for the prespecified final primary endpoint must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.3 and M15 §15.3.1–15.3.3: status separation is in-house; M15 §15.3.1–15.3.3: in-house 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": "A preserved proposal for follow-up research that adequately reports the final-visit effect and uncertainty. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Final week-12 change values",
      "needed": "Distinction between final changes from baseline and absolute values",
      "role": "Required",
      "role_reason": "This item distinguishes distinction between final changes from baseline and absolute values to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for distinction between final changes from baseline and absolute values must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; 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": "A preserved proposal for follow-up research that reports changes and final absolute values separately. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Whole-time mixed model",
      "needed": "Specification of the whole-trajectory test and individual-visit effects",
      "role": "Required",
      "role_reason": "This item distinguishes specification of the whole-trajectory test and individual-visit effects to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for specification of the whole-trajectory test and individual-visit effects must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; 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 adaptation 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": "A preserved proposal for follow-up research that distinguishes the whole trajectory from final and intermediate contrasts. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Primary-endpoint and intermediate-result hierarchy",
      "needed": "Hierarchy of the prespecified final week-12 primary endpoint and intermediate visits",
      "role": "Required",
      "role_reason": "This item distinguishes hierarchy of the prespecified final week-12 primary endpoint and intermediate visits to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for hierarchy of the prespecified final week-12 primary endpoint and intermediate visits must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is 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": "A preserved proposal for follow-up research that explicitly specifies the final and intermediate endpoint hierarchy. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Unreported CIs and meaningful benefit",
      "needed": "Exact effects, CIs and importance thresholds",
      "role": "Required",
      "role_reason": "This item distinguishes exact effects, CIs and importance thresholds to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for exact effects, CIs and importance thresholds must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; 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": "A preserved proposal for follow-up research that specifies CIs and importance thresholds. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "220 randomized and 213 in PPS",
      "needed": "Distinction between randomized and analyzed populations and group- or visit-specific denominators",
      "role": "Required",
      "role_reason": "This item distinguishes distinction between randomized and analyzed populations and group- or visit-specific denominators to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for distinction between randomized and analyzed populations and group- or visit-specific denominators must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M08 §8.1–8.2.3; 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": "A preserved proposal for follow-up research that reports the full randomized population and PPS results together. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Withdrawal, missing data and analysis exclusions",
      "needed": "Reasons for withdrawal, missing data, group-specific effects and handling",
      "role": "Required",
      "role_reason": "This item distinguishes reasons for withdrawal, missing data, group-specific effects and handling to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for reasons for withdrawal, missing data, group-specific effects and handling must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that distinguishes the effects of missingness and nonadherence. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Within-group change and between-group comparison",
      "needed": "Group correspondence and within- or between-group change estimands",
      "role": "Required",
      "role_reason": "This item distinguishes group correspondence and within- or between-group change estimands to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for group correspondence and within- or between-group change estimands must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome 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": "A preserved proposal for follow-up research that clearly reports within- and between-group estimands. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "UMIN identifier and reading of prespecified plans",
      "needed": "Actual verification scope for registration, protocol, SAP and change history",
      "role": "Required",
      "role_reason": "This item distinguishes actual verification scope for registration, protocol, SAP and change history to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for actual verification scope for registration, protocol, SAP and change history must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect 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": "A preserved proposal for follow-up research that links prespecified plans with the analyses actually performed. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Multiple visits, sites and tests",
      "needed": "Multiplicity specification for intermediate visits, skin sites and analyses",
      "role": "Required",
      "role_reason": "This item distinguishes multiplicity specification for intermediate visits, skin sites and analyses to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for multiplicity specification for intermediate visits, skin sites and analyses must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort and outcome linkage is an internal application; 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": "A preserved proposal for follow-up research that distinguishes multiple-visit findings from the final primary endpoint. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Concurrent skin care, season and lifestyle",
      "needed": "Group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records",
      "role": "Required",
      "role_reason": "This item distinguishes group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that explicitly specifies concurrent conditions. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Provision of study and placebo beverages",
      "needed": "Manufacturer product support and scope of provision",
      "role": "Required",
      "role_reason": "This item distinguishes manufacturer product support and scope of provision to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for manufacturer product support and scope of provision must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A proposed follow-up trial disclosing support roles; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Employee authors and contract organization",
      "needed": "Author affiliations and roles of the company and contract organization",
      "role": "Required",
      "role_reason": "This item distinguishes author affiliations and roles of the company and contract organization to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for author affiliations and roles of the company and contract organization must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that separately discloses company and contract-organization roles. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Public funding, writing and publication costs",
      "needed": "Item-specific reporting of funding, writing and publication support",
      "role": "Required",
      "role_reason": "This item distinguishes item-specific reporting of funding, writing and publication support to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for item-specific reporting of funding, writing and publication support must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A preserved proposal for follow-up research that separately discloses each support category. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Same trial and intermediate or final results",
      "needed": "Report-to-trial, visit, site and denominator relationships and independent replication",
      "role": "Required",
      "role_reason": "This item distinguishes report-to-trial, visit, site and denominator relationships and independent replication to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for report-to-trial, visit, site and denominator relationships and independent replication must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that independently compares the same final and intermediate outcome specifications. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Persistence and other formulations or skin outcomes",
      "needed": "Distinction between intermediate changes, sustained effects and other skin or clinical outcomes",
      "role": "Required",
      "role_reason": "This item distinguishes distinction between intermediate changes, sustained effects and other skin or clinical outcomes to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for distinction between intermediate changes, sustained effects and other skin or clinical outcomes must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundaries; 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": "A preserved proposal for follow-up research that distinguishes persistence from applicability across formulations and populations. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Original safety record and scope",
      "needed": "12-week safety collection, denominators and frequencies, and rare or long-term harms",
      "role": "Supplementary",
      "role_reason": "This item distinguishes 12-week safety collection, denominators and frequencies, and rare or long-term harms to connect the evidence needed for the selected question with the evidence currently available.",
      "application_exception": "Complements safety-data gaps for the selected subclaim. Intermediate/final skin hydration, self-reported sleepiness or parent cautionary wording are not used to judge safety or create harm-incidence estimates/new use instructions.",
      "criterion": "Relevant source data and analysis details for 12-week safety collection, denominators and frequencies, and rare or long-term harms must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is 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": "A preserved proposal for follow-up research that specifies harm collection and the scope of longer-term or other-population evidence. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Parent/subclaim, bilingual text and history",
      "needed": "Separate preservation of original values, axes, reference date and correction or verification statements",
      "role": "Required",
      "role_reason": "This item distinguishes separate preservation of original values, axes, reference date and correction or verification statements to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for separate preservation of original values, axes, reference date and correction or verification statements must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A preserved proposal for follow-up research that distinguishes original values and history from application of new updates. No new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Summary reading, external materials and links",
      "needed": "Actual reading scope and access status of original articles, registration, plans and support records",
      "role": "Required",
      "role_reason": "This item distinguishes actual reading scope and access status of original articles, registration, plans and support records to connect the evidence needed for the selected question with the evidence currently available.",
      "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 source data and analysis details for actual reading scope and access status of original articles, registration, plans and support records must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A preserved proposal for follow-up research that distinguishes the timing and scope of acquired material when updating. No new investigation, calculation or trial was performed."
    }
  ]
}
