{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "DDMP lactic-acid-bacteria beverage × Original null finding for stratum-corneum moisture at 12 weeks",
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How is the selected 12-week question distinguished from intermediate-time sibling findings?",
      "needed": "12-week question/verdict connection and parent/intermediate scope",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How is the selected 12-week question distinguished from intermediate-time sibling findings?",
      "application_exception": "Do not fill the selected 12-week claim or grade with positive intermediate findings.",
      "criterion": "Separate original information about 12-week question/verdict connection and parent/intermediate scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing final 12-week and intermediate estimands"
    },
    {
      "item_id": "N02",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What are the subclaim D grade/note and absent values?",
      "needed": "Subclaim grade/note, absent score/status/axes and parent history",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the subclaim D grade/note and absent values?",
      "application_exception": "Do not transfer parent 28 points or its original C0 axis into subclaim values or current review approval.",
      "criterion": "Separate original information about Subclaim grade/note, absent score/status/axes and parent history from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate original-grade preservation from additional evidence/corrections"
    },
    {
      "item_id": "N03",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Who was studied, and how are dry skin and disease distinguished?",
      "needed": "Healthy Japanese adults with dry skin, eligibility and baseline scope",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Who was studied, and how are dry skin and disease distinguished?",
      "application_exception": "Do not extend measurements in healthy adults into skin-disease treatment or effects in every population.",
      "criterion": "Separate original information about Healthy Japanese adults with dry skin, eligibility and baseline scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the population and definition of dry skin"
    },
    {
      "item_id": "N04",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What is the studied identity of DDMP and the beverage?",
      "needed": "2.2 mg DDMP, 65 mL beverage and chemical/product specifications",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is the studied identity of DDMP and the beverage?",
      "application_exception": "Do not newly add mechanisms, strains/counts, product names or dose conversions without original information.",
      "criterion": "Separate original information about 2.2 mg DDMP, 65 mL beverage and chemical/product specifications from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the precise DDMP/beverage scope"
    },
    {
      "item_id": "N05",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What comparison does the control beverage answer?",
      "needed": "Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What comparison does the control beverage answer?",
      "application_exception": "Do not extend the result into no benefit from all lactic-acid-bacteria beverages or the isolated effect of a particular strain.",
      "criterion": "Separate original information about Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the DDMP contrast on an identical-beverage background"
    },
    {
      "item_id": "N06",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What were original exposure, intake frequency and adherence?",
      "needed": "Original 2.2 mg/65 mL, frequency and actual exposure",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were original exposure, intake frequency and adherence?",
      "application_exception": "Do not create or convert daily intake, probiotic/product instructions or management methods.",
      "criterion": "Separate original information about Original 2.2 mg/65 mL, frequency and actual exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating intended provision from actual exposure"
    },
    {
      "item_id": "N07",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How are the 12-week endpoint, visits and persistence distinguished?",
      "needed": "Final week 12, week 4/8 visits and post-discontinuation outcomes",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the 12-week endpoint, visits and persistence distinguished?",
      "application_exception": "Do not establish sustained moisturizing benefit from positive intermediate findings or 12-week follow-up.",
      "criterion": "Separate original information about Final week 12, week 4/8 visits and post-discontinuation outcomes from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating final, intermediate and post-study questions"
    },
    {
      "item_id": "N08",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What were measurement sites, methods/environment and moisture units?",
      "needed": "Skin measurement sites, equipment/environment and a.u. definition",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were measurement sites, methods/environment and moisture units?",
      "application_exception": "Do not turn a.u. into water-content percentages, site-specific effects or moisturizer/skin-care instructions.",
      "criterion": "Separate original information about Skin measurement sites, equipment/environment and a.u. definition from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research fixing site/environment and measurement definitions"
    },
    {
      "item_id": "N09",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What original comparison describes final absolute moisture at 12 weeks?",
      "needed": "29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original comparison describes final absolute moisture at 12 weeks?",
      "application_exception": "Do not newly certify exactly zero effect, equivalence or no response in every person from equal displayed means.",
      "criterion": "Separate original information about 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying the final-visit between-arm estimand"
    },
    {
      "item_id": "N10",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How does change from baseline at 12 weeks differ from final values?",
      "needed": "+8.05±6.85 versus +7.92±5.97, P=0.877",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How does change from baseline at 12 weeks differ from final values?",
      "application_exception": "Do not calculate new net effects, baseline values or percentages from the two changes.",
      "criterion": "Separate original information about +8.05±6.85 versus +7.92±5.97, P=0.877 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating final values from changes and within-arm from between-arm estimands"
    },
    {
      "item_id": "N11",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Are the original no-95%-CI narrative and uncertainty distinguished?",
      "needed": "Original no-CI narrative, effect intervals/importance and meaning of ±",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are the original no-95%-CI narrative and uncertainty distinguished?",
      "application_exception": "Do not arbitrarily interpret ± as CI/SD or reconstruct CIs from the original numbers.",
      "criterion": "Separate original information about Original no-CI narrative, effect intervals/importance and meaning of ± from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying effects, intervals and importance"
    },
    {
      "item_id": "N12",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Which time points do positive week 4/8 findings describe?",
      "needed": "Intermediate changes/P values, sibling original grade and final-visit boundary",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Which time points do positive week 4/8 findings describe?",
      "application_exception": "Do not copy week 4/8 numbers into week 12 or new independent trials/replications, or calculate new time-specific differences.",
      "criterion": "Separate original information about Intermediate changes/P values, sibling original grade and final-visit boundary from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research fixing visit-specific estimands and hierarchy"
    },
    {
      "item_id": "N13",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What does a positive whole-time mixed model mean?",
      "needed": "Whole-time P<0.001 versus final 12-week and change results",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What does a positive whole-time mixed model mean?",
      "application_exception": "Do not newly grade whole-time significance as 12-week primary-efficacy success or persistent benefit.",
      "criterion": "Separate original information about Whole-time P<0.001 versus final 12-week and change results from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating longitudinal estimands from final contrasts"
    },
    {
      "item_id": "N14",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What is known about prespecified final-primary versus intermediate/secondary hierarchy?",
      "needed": "Original final-primary narrative, registry/SAP and intermediate hierarchy",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about prespecified final-primary versus intermediate/secondary hierarchy?",
      "application_exception": "Preserve the original prespecification narrative without inventing current external registry-content certification.",
      "criterion": "Separate original information about Original final-primary narrative, registry/SAP and intermediate hierarchy from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating final/intermediate and primary/secondary/exploratory outcomes"
    },
    {
      "item_id": "N15",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What registration and bibliographic identifiers are supplied or absent?",
      "needed": "UMIN000052867, PMID40151405 and DOI/PMCID scope",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What registration and bibliographic identifiers are supplied or absent?",
      "application_exception": "Do not turn absent identifiers into actual non-registration, absent full text or failed access, or guess a DOI.",
      "criterion": "Separate original information about UMIN000052867, PMID40151405 and DOI/PMCID scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Link identifiers, prespecified plans and published results"
    },
    {
      "item_id": "N16",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?",
      "needed": "Randomized versus PPS populations and arm/outcome-specific denominators",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?",
      "application_exception": "Do not newly calculate 220−213, arm samples or attrition rates.",
      "criterion": "Separate original information about Randomized versus PPS populations and arm/outcome-specific denominators from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying randomized versus analysis populations"
    },
    {
      "item_id": "N17",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What were actual attrition, protocol-deviation and missing-measurement reasons?",
      "needed": "Not analyzed/missing, adherence deviations, discontinuation and handling",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were actual attrition, protocol-deviation and missing-measurement reasons?",
      "application_exception": "Do not turn every PPS exclusion into attrition/adverse effects or create new numbers or flaw grades.",
      "criterion": "Separate original information about Not analyzed/missing, adherence deviations, discontinuation and handling from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating missingness/deviations from estimands"
    },
    {
      "item_id": "N18",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How do skin sites, repeated measurements and arms/visits differ from people?",
      "needed": "Analysis units for people, multiple sites/measurements and visits",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How do skin sites, repeated measurements and arms/visits differ from people?",
      "application_exception": "Do not invent skin-site/night data or newly add visit-specific samples.",
      "criterion": "Separate original information about Analysis units for people, multiple sites/measurements and visits from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating people from repeated sites/time points"
    },
    {
      "item_id": "N19",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What were baseline conditions, environment/season and concurrent moisturizing exposures?",
      "needed": "Arm-specific baseline moisture, environment/lifestyle and concurrent skin care",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were baseline conditions, environment/season and concurrent moisturizing exposures?",
      "application_exception": "Do not newly add management methods, moisturizing products/treatments as actual study elements or implementation instructions.",
      "criterion": "Separate original information about Arm-specific baseline moisture, environment/lifestyle and concurrent skin care from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying measurement environment and shared exposures"
    },
    {
      "item_id": "N20",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Were randomization, allocation concealment and baseline balance verified?",
      "needed": "Parallel randomization, sequence/concealment and baseline tables",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were randomization, allocation concealment and baseline balance verified?",
      "application_exception": "Do not certify adequate allocation or no bias from the RCT label or original B1 axis alone.",
      "criterion": "Separate original information about Parallel randomization, sequence/concealment and baseline tables from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 §8.1–8.2.3; own application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "An allocation plan for the identical-beverage comparison"
    },
    {
      "item_id": "N21",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What was the actual scope of double blinding, beverage equivalence and measurement procedures?",
      "needed": "Blinding of participants/measurers/analysts, equivalence and condition awareness",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the actual scope of double blinding, beverage equivalence and measurement procedures?",
      "application_exception": "Do not inherit the original double-blind design as current successful-blinding review or independence certification.",
      "criterion": "Separate original information about Blinding of participants/measurers/analysts, equivalence and condition awareness from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying measurement and condition awareness"
    },
    {
      "item_id": "N22",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What are PPS, absolute/change and within-/between-arm estimands?",
      "needed": "Assignment/adherent-participant effects and original final/change analyses",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are PPS, absolute/change and within-/between-arm estimands?",
      "application_exception": "Do not copy PPS results as all-randomized effects or turn within-arm changes into between-arm efficacy.",
      "criterion": "Separate original information about Assignment/adherent-participant effects and original final/change analyses from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying assignment/adherent and final/change estimands"
    },
    {
      "item_id": "N23",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What original information concerns manufacturers, contractors and provision/support?",
      "needed": "Nissin York provision, employee authors, M&I Science and support scope",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original information concerns manufacturers, contractors and provision/support?",
      "application_exception": "Do not combine the contractor author with company employee authors or turn original support narratives into current content-review/independence judgments.",
      "criterion": "Separate original information about Nissin York provision, employee authors, M&I Science and support scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Specify support and decision/analysis roles"
    },
    {
      "item_id": "N24",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How are the same citation, trial, time points and siblings linked?",
      "needed": "The same Sato2025 report and observation/participant relationships",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the same citation, trial, time points and siblings linked?",
      "application_exception": "One report is not certification of the total independent-trial count or final clinical-independence count.",
      "criterion": "Separate original information about The same Sato2025 report and observation/participant relationships from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records distinguishing reports from study families"
    },
    {
      "item_id": "N25",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What direct independent replications or other manufacturer/product data exist?",
      "needed": "Separate independent reports for the same 12-week DDMP-beverage question",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What direct independent replications or other manufacturer/product data exist?",
      "application_exception": "Do not extend the original single-trial narrative into a current absence of every study, or count sibling tables as independent replication.",
      "criterion": "Separate original information about Separate independent reports for the same 12-week DDMP-beverage question from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate research addressing the same question"
    },
    {
      "item_id": "N26",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What are extrapolation boundaries for other beverages/strains, populations and sites?",
      "needed": "Studied identity versus direct comparisons for other formulations/populations/sites",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are extrapolation boundaries for other beverages/strains, populations and sites?",
      "application_exception": "Do not newly declare no benefit from all lactic-acid bacteria or create product recommendations/intake/skin-care instructions.",
      "criterion": "Separate original information about Studied identity versus direct comparisons for other formulations/populations/sites from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying precise study identity and applicability"
    },
    {
      "item_id": "N27",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Are intermediate differences, final disappearance and persistence distinguished?",
      "needed": "Original week 4/8 positive findings, final week 12 null finding and longer term",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are intermediate differences, final disappearance and persistence distinguished?",
      "application_exception": "Preserve the original conclusion without extending it into zero effect in every long-term situation or permanently no effect.",
      "criterion": "Separate original information about Original week 4/8 positive findings, final week 12 null finding and longer term from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research distinguishing timing/persistence questions"
    },
    {
      "item_id": "N28",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?",
      "needed": "Measurement endpoints versus skin symptoms, quality of life and disease treatment",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?",
      "application_exception": "Do not turn null measurements into no benefit from every skin treatment, treatment substitution or moisturizing-management instructions.",
      "criterion": "Separate original information about Measurement endpoints versus skin symptoms, quality of life and disease treatment from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating moisture testing from patient-important outcomes"
    },
    {
      "item_id": "N29",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What was actually read, externally unread and linked?",
      "needed": "Complete preserved summary, abstract/full text/plans and source connections",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was actually read, externally unread and linked?",
      "application_exception": "Do not declare external acquisition/reading, successful access or failed access based on a URL/ID.",
      "criterion": "Separate original information about Complete preserved summary, abstract/full text/plans and source connections from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "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": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Records separating preserved summaries from newly acquired materials"
    },
    {
      "item_id": "N30",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What are original bilingual text, dates, axes/absences, corrections and history?",
      "needed": "Original languages/dates, parent axes/score and empty/absent values",
      "role": "Required",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are original bilingual text, dates, axes/absences, corrections and history?",
      "application_exception": "Do not inherit original flaw/size/duration scoring or cross-check wording as current review/rescoring, or invent absent fields.",
      "criterion": "Separate original information about Original languages/dates, parent axes/score and empty/absent values from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Separate original values/absences from new updates"
    },
    {
      "item_id": "N31",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What was the original scope of adverse-event collection and serious safety signals?",
      "needed": "Collection methods/definitions, severity, relatedness and original narrative",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the original scope of adverse-event collection and serious safety signals?",
      "application_exception": "Do not turn no reported serious related signal into zero adverse events of all types or guaranteed absence of harm/safety.",
      "criterion": "Separate original information about Collection methods/definitions, severity, relatedness and original narrative from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research specifying harm collection separately from efficacy"
    },
    {
      "item_id": "N32",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Are dairy-allergy/intolerance cautions actual events?",
      "needed": "Original cautionary context and relevant populations/event data",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are dairy-allergy/intolerance cautions actual events?",
      "application_exception": "Do not create new product-checking/avoidance, intake/treatment instructions or allergy counts absent from the original.",
      "criterion": "Separate original information about Original cautionary context and relevant populations/event data from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Safety questions specifying vulnerable populations"
    },
    {
      "item_id": "N33",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Were arm-specific harms and event/exposure denominators verified?",
      "needed": "All-randomized/PPS populations versus harm collection and arm comparisons",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were arm-specific harms and event/exposure denominators verified?",
      "application_exception": "Do not automatically apply PPS 213 as a harm denominator or calculate zero events, incidence, differences or CIs.",
      "criterion": "Separate original information about All-randomized/PPS populations versus harm collection and arm comparisons from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan separating efficacy from harm-collection populations"
    },
    {
      "item_id": "N34",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What were harm timing and on-/post-exposure follow-up?",
      "needed": "12-week scope, event timing and post-discontinuation/delayed observation",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were harm timing and on-/post-exposure follow-up?",
      "application_exception": "Do not turn 12-week efficacy duration into completed long-term safety verification.",
      "criterion": "Separate original information about 12-week scope, event timing and post-discontinuation/delayed observation from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research prespecifying timing and delayed harms"
    },
    {
      "item_id": "N35",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What alternative causes concern DDMP, shared beverage, illnesses or drugs?",
      "needed": "Shared dairy/beverage, concurrent exposures and harm attribution",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What alternative causes concern DDMP, shared beverage, illnesses or drugs?",
      "application_exception": "Do not turn shared-ingredient cautions into established DDMP harms or new treatment/prevention instructions.",
      "criterion": "Separate original information about Shared dairy/beverage, concurrent exposures and harm attribution from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A harm plan separating the exposure of interest from alternative causes"
    },
    {
      "item_id": "N36",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "Were PPS exclusions, missingness and harm-related discontinuations verified?",
      "needed": "PPS populations, exclusion/discontinuation reasons and missing harm collection",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were PPS exclusions, missingness and harm-related discontinuations verified?",
      "application_exception": "Do not calculate new differences/ratios from 220/213 or turn exclusions into people with adverse effects.",
      "criterion": "Separate original information about PPS populations, exclusion/discontinuation reasons and missing harm collection from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "A plan distinguishing missingness from harm-related discontinuation"
    },
    {
      "item_id": "N37",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How are independent harm reports distinguished from observations in the same trial?",
      "needed": "Separate harm identities, exposures/populations and overlap",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are independent harm reports distinguished from observations in the same trial?",
      "application_exception": "No separate current slot does not establish absence of every external harm report.",
      "criterion": "Separate original information about Separate harm identities, exposures/populations and overlap from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Independent harm research with clear exposures/populations"
    },
    {
      "item_id": "N38",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What is known about vulnerable populations, other illnesses/beverages and long-term safety?",
      "needed": "Original healthy adults versus allergy/illness and repeated/long-term scope",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about vulnerable populations, other illnesses/beverages and long-term safety?",
      "application_exception": "Do not newly propose probiotic/product intake, skin-care or treatment-substitution methods.",
      "criterion": "Separate original information about Original healthy adults versus allergy/illness and repeated/long-term scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research separating population and long-term safety questions"
    },
    {
      "item_id": "N39",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "What are the causal scopes of final null, intermediate positive and good safety findings?",
      "needed": "Separate efficacy/timing, original safety grade and comparative harms",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the causal scopes of final null, intermediate positive and good safety findings?",
      "application_exception": "Do not extend findings into certification of efficacy/safety for an entire device/ingredient or assign new grades/causality.",
      "criterion": "Separate original information about Separate efficacy/timing, original safety grade and comparative harms from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Plan separating different outcomes/estimands"
    },
    {
      "item_id": "N40",
      "question_type": "12-week stratum-corneum moisture and evidence gaps",
      "question": "How are follow-up materials, historical candidates, versions and incomplete content review linked?",
      "needed": "Review summary/criteria, new materials/original values, historical candidates and user decisions",
      "role": "Supplementary",
      "role_reason": "Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete content review connected?",
      "application_exception": "Do not invent current clinical review or completed publication from historical cross-checks or completed production.",
      "criterion": "Separate original information about Review summary/criteria, new materials/original values, historical candidates and user decisions from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual records based on preserved original materials; existing content review incomplete",
      "proposed_research": "Research directly addressing gaps in selected 12-week moisture"
    }
  ]
}