{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2979-s0",
  "verdict_number": "2979",
  "title": "DDMP lactic-acid-bacteria beverage × Original null finding for stratum-corneum moisture at 12 weeks",
  "view_version": "1.0",
  "view_created_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "Healthy Japanese adults with dry skin; original 220 randomized/PPS 213 analyzed",
    "intervention": "A 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP",
    "dose": "Original 2.2 mg DDMP/65 mL beverage exposure is preserved; frequency/total intake are unverified. No intake/conversion instructions.",
    "comparator": "The identical lactic-acid-bacteria beverage with only DDMP removed",
    "endpoint": "Final stratum-corneum moisture at 12 weeks (a.u.), distinguished from baseline change; site/environment/unit details are unverified",
    "duration": "12 weeks, distinguished from intermediate weeks 4/8 and post-study/long-term effects",
    "excluded_extensions": [
      "Replacing 12-week efficacy with positive intermediate week 4/8 or whole-time-model findings",
      "Extending the DDMP identical-beverage contrast to all lactic-acid bacteria, other products or skin-disease effects",
      "Converting final/change values, a.u. or ± into new effects, CIs or percentages",
      "Adding people, arms, sites, visits, siblings or the same citation as independent trials/participants",
      "Instructions for probiotic/product intake, skin/moisturizing management or treatment substitution"
    ]
  },
  "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The selected original question is increased stratum-corneum moisture at 12 weeks. Its subclaim record is linked, while changes at weeks 4 and 8 remain original context. No new question, split or trial is created.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Clinical independence was not newly certified.",
      "missingness": "Clinical independence was not newly certified.",
      "uncertainty": "Clinical independence was not newly certified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original question/time, measurement/comparison and scope-change records"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The selected D grade and note, 29.7 versus 29.7 a.u., P=0.985, are preserved. Subclaim score/status/axes are absent; parent D28 and axes are separate historical context.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.",
      "missingness": "Subclaim score/status/axes are absent in the original.",
      "uncertainty": "Subclaim score/status/axes are absent in the original.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Subclaim original and explicit change events"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records 220 healthy Japanese adults with dry skin. This is not direct treatment/moisturizing efficacy in skin-disease patients or all ages/regions.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.",
      "missingness": "Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.",
      "uncertainty": "Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Eligibility criteria and baseline/diagnostic tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original intervention is a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. The long chemical name remains in the original citation; DDMP is not replaced by a specific strain/organism count or all probiotics.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.",
      "missingness": "Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.",
      "uncertainty": "Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Beverage/ingredient specifications and analysis of the actual test product"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original control is the same lactic-acid-bacteria beverage with only DDMP removed. It is not a comparison with no intake, another product or no lactic-acid bacteria.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.",
      "missingness": "Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.",
      "uncertainty": "Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Test/control composition, quality and blinding information"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original gives a 65 mL beverage containing 2.2 mg and a 12-week duration. Intake frequency, daily total, timing and actual adherence quantities are not separately supplied in this summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.",
      "missingness": "Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.",
      "uncertainty": "Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Study exposure schedule and adherence/provision records"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records 12-week follow-up, the final primary stratum-corneum moisture endpoint and intermediate weeks 4 and 8. Persistence after study completion and longer-use results are not supplied.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.",
      "missingness": "Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.",
      "uncertainty": "Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Visit/exposure schedules and follow-up results"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original final 12-week unit is a.u. (arbitrary units). Measurement sites, equipment, temperature/humidity, acclimation, repetitions and formulas are absent from the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.",
      "missingness": "Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.",
      "uncertainty": "Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Measurement methods, environment/sites and original test tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original final 12-week values are 29.7±7.67 for the test beverage versus 29.7±6.19 a.u. for control, P=0.985. The original null narrative is preserved; no new difference, effect or CI is calculated.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.",
      "missingness": "The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.",
      "uncertainty": "The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Final-value, model/denominator and measurement result tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original 12-week change from baseline is +8.05±6.85 versus +7.92±5.97, P=0.877. This remains a different result representation from final 29.7 a.u.; positive within-arm change does not mean between-arm benefit.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.",
      "missingness": "Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.",
      "uncertainty": "Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline/change and denominator/model result tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original states that no 95% CI was reported and a meaningful benefit cannot be excluded. No external paper was newly read in this run to verify that reporting statement.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.",
      "missingness": "The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.",
      "uncertainty": "The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original analysis results and precision/importance plans"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original week 4 changes +4.28 versus −2.09 (P<0.001) and week 8 +8.47 versus +5.17 (P=0.002) are preserved. The sibling is C with a positive-intermediate/disappearing-final note; it does not replace the selected 12-week D result.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.",
      "missingness": "Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.",
      "uncertainty": "Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Intermediate/final results and protocol/SAP"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original counterview records that whole-time mixed-model P<0.001 describes differing trajectories, not a 12-week effect. It does not replace final P=.985/.877.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.",
      "missingness": "Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.",
      "uncertainty": "Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Time-model/SAP and visit-specific analyses"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original bilingual text/evidence records week 12 as the prespecified final primary endpoint. Exact prespecified secondary/exploratory hierarchy and success/multiplicity rules for intermediate visits are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Actual external planning versions, hierarchy/timing and testing rules remain unread.",
      "missingness": "Actual external planning versions, hierarchy/timing and testing rules remain unread.",
      "uncertainty": "Actual external planning versions, hierarchy/timing and testing rules remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registry, protocol/SAP and outcome lists"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original registration record contains UMIN000052867 and the citation supplies PMID40151405. It is linked as a UMIN ID, not NCT. DOI/PMCID are absent from the citation.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.",
      "missingness": "DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.",
      "uncertainty": "DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original bibliography/registry and protocol/SAP"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original 220 randomized and 213 protocol-compliant participants analyzed are preserved. Arm-specific randomized/analysis and valid outcome/visit denominators are not separately supplied.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.",
      "missingness": "Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.",
      "uncertainty": "Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Participant flow, arm/visit denominators and PPS criteria"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "PPS 213 alone does not establish whether exclusions reflect lost follow-up, exposure violations, missing measurements or other reasons. ITT, imputation and sensitivity analyses are absent.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.",
      "missingness": "Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.",
      "uncertainty": "Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Participant flow, deviation/missingness records and SAP"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original samples are 220/213 people; measurement sites/repeated aggregation are unverified. The same people, arms, sites and weeks 4/8/12 are not added as new independent trials/participants.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.",
      "missingness": "Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.",
      "uncertainty": "Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Site/visit data and analysis-unit/SAP information"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The current summary has no detailed control or arm differences for baseline moisture, environment/season, skin care/diet or concurrent treatment.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Baseline testing, environment/season, shared management/drugs and exposure records are unverified.",
      "missingness": "Baseline testing, environment/season, shared management/drugs and exposure records are unverified.",
      "uncertainty": "Baseline testing, environment/season, shared management/drugs and exposure records are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline/measurement environment, concurrent exposures and protocol"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original design is a double-blind randomized identical-beverage placebo-controlled parallel trial. Allocation procedures, concealment and baseline balance are not detailed in the summary.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.",
      "missingness": "Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.",
      "uncertainty": "Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation procedures, baseline tables and protocol"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records double blinding and identical beverages. Who was blinded and how, equivalence/condition awareness and moisture-measurement standardization are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.",
      "missingness": "Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.",
      "uncertainty": "Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Blinding/equivalence and measurement-standardization information"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Primary PPS 213 and original final 12-week/change-from-baseline contrasts are distinguished. Baseline/covariate adjustment, estimands and models are not detailed.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.",
      "missingness": "Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.",
      "uncertainty": "Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "SAP and results/denominators for each estimand"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original states Nissin York supplied test/placebo beverages; T.S., M.T. and S.S. worked at its development institute, while M.M. worked at contract organization M&I Science. The original no-separate-public-funding/medical-writing/publication-fee narrative is preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Current detailed original disclosures, support and design/analysis/data-access roles remain unread.",
      "missingness": "Current detailed original disclosures, support and design/analysis/data-access roles remain unread.",
      "uncertainty": "Current detailed original disclosures, support and design/analysis/data-access roles remain unread.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original support/provision, author relationships/roles and disclosures"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Current evidence/citation lists each contain one Sato2025 record, linked as one report. Both identical-beverage arms, weeks 4/8/12, skin sites and siblings share this context; they are not newly added independent trials/participants.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.",
      "missingness": "Related report/trial relationships and unique trial/participant totals are unverified.",
      "uncertainty": "Related report/trial relationships and unique trial/participant totals are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial/related-report identities and observation units"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records one manufacturer-linked trial and historical R1/I0 axes. Other direct studies/products were not searched for or verified in this run.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.",
      "missingness": "Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.",
      "uncertainty": "Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct confirmatory/replication reports and trial identities"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original scope is a DDMP-containing identical-beverage comparison in healthy Japanese adults with dry skin. Direct values for other bacteria/beverages, products, skin diseases/populations/sites are not supplied.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects/CIs and interactions by population, product or site are unverified.",
      "missingness": "Direct effects/CIs and interactions by population, product or site are unverified.",
      "uncertainty": "Direct effects/CIs and interactions by population, product or site are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct formulation/population/measurement-site data"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original states intermediate differences disappeared at week 12 and benefit did not persist. Post-week-12 persistence, repeated-use and recurrence data are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.",
      "missingness": "Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.",
      "uncertainty": "Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Time-specific/post-study results and plans"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original endpoint is stratum-corneum moisture. Separate direct treatment effects on symptoms, quality of life or clinical skin-disease outcomes are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Patient-important/disease outcome definitions, effects, denominators and durations are unverified.",
      "missingness": "Patient-important/disease outcome definitions, effects, denominators and durations are unverified.",
      "uncertainty": "Patient-important/disease outcome definitions, effects, denominators and durations are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct symptom/clinical-outcome information"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The complete preserved 2979 summary was read and saved for production. Original PubMed and UMIN identifiers connect sources; external content/link access, clicks and tests were not performed in that production.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Current external original methods/results and registry/plans remain unverified.",
      "missingness": "Current external original methods/results and registry/plans remain unverified.",
      "uncertainty": "Current external original methods/results and registry/plans remain unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Acquired original materials and actual reading/addition events"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Bilingual text, the original date 2026-08-26, empty correction/deliberation records and parent D28 are preserved. B/S/R1/I0/E0/B1/C0 axes, three false flags and empty override reasons are historical. Original detailed-classification and primary-failure/secondary-positive fields are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, original-text and correction comparisons were not performed in this run.",
      "missingness": "External detailed translation, original-text and correction comparisons were not performed in this run.",
      "uncertainty": "External detailed translation, original-text and correction comparisons were not performed in this run.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Language-specific originals/revisions and dated correction events"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original records no reported serious safety signal related to the test beverage during 12-week intake. Collection methods, all-event/severity and relatedness-adjudication tables are absent.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Adverse-event definitions/collection, all events and relatedness adjudication are unverified.",
      "missingness": "Adverse-event definitions/collection, all events and relatedness adjudication are unverified.",
      "uncertainty": "Adverse-event definitions/collection, all events and relatedness adjudication are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harm plans, event/discontinuation and relatedness tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original separately mentions dairy-ingredient allergy/intolerance. This is not a count or causal result showing allergy events occurred in this trial.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Eligibility/relevant populations and actual events/denominators/severity are unverified.",
      "missingness": "Eligibility/relevant populations and actual events/denominators/severity are unverified.",
      "uncertainty": "Eligibility/relevant populations and actual events/denominators/severity are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Population/event and exposure/relatedness data"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "It is unverified whether all 220/PPS 213 match the harm-collection population. Arm-specific events/denominators, effects and CIs are absent.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.",
      "missingness": "Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.",
      "uncertainty": "Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harm flow and events/denominator tables by arm"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The original has a safety narrative for 12-week exposure but no separate event timing, period-specific observation or post-study/delayed-harm follow-up.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Event timing and on-exposure/post-discontinuation/long-term observation are unverified.",
      "missingness": "Event timing and on-exposure/post-discontinuation/long-term observation are unverified.",
      "uncertainty": "Event timing and on-exposure/post-discontinuation/long-term observation are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Harm/exposure timing and follow-up information"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The context compares presence/absence of DDMP in identical beverages. Actual information attributing harm to DDMP, the shared beverage or other factors is absent.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.",
      "missingness": "Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.",
      "uncertainty": "Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "History/exposure and event/relatedness records"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "PPS 213 alone does not establish whether analysis exclusions were harm-related. Event collection/handling in omitted participants is also absent.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.",
      "missingness": "Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.",
      "uncertainty": "Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Flow/exclusions, harm-related discontinuations and missing data"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "The current listing is this beverage efficacy report. Separate original harm materials were not searched for/acquired in this run; the same report, arms, visits and siblings are not independent harm trials.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.",
      "missingness": "Independent harm-report identities, populations/exposures and overlap are unverified.",
      "uncertainty": "Independent harm-report identities, populations/exposures and overlap are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Separate harm/surveillance and event materials"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "12-week data in healthy Japanese adults with dry skin do not establish safety for other beverages/populations, illnesses or longer repeated exposure.",
      "condition_status": "Unverified",
      "status_reason": "Needed direct information was not verified within the current summary and unread-external-material scope. Population-specific histories/drugs and direct long-term/repeated harms are unverified.",
      "missingness": "Population-specific histories/drugs and direct long-term/repeated harms are unverified.",
      "uncertainty": "Population-specific histories/drugs and direct long-term/repeated harms are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct harm data by vulnerable/disease population and exposure duration"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Original 12-week null findings, positive week 4/8 findings, no reported serious related safety signal and parent good safety status are preserved separately. Null efficacy does not establish harms or guarantee safety.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Direct comparative/causal safety and long-term precision are unverified.",
      "missingness": "Direct comparative/causal safety and long-term precision are unverified.",
      "uncertainty": "Direct comparative/causal safety and long-term precision are unverified.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Separate comparative-harm/follow-up data alongside efficacy"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "A preserved beverage-trial summary exists; external details/follow-up remain unread/needed",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "observation": "Criteria were saved and frozen before separate application. Original pending/eligible candidates remain history. Content/question-boundary review is incomplete; completion flags are false, new units are 0 and final independent counts remain unrecorded.",
      "condition_status": "Partly verified",
      "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.",
      "missingness": "Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.",
      "uncertainty": "Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Additional original materials, before/after values, versions and change-decision records"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Sato T, et al. Effect of 2,3-dihydro-3,5-dihydroxy-6-methyl-4H-pyran-4-one-containing lactic acid bacterial beverages on skin moisture. J Nutr Sci Vitaminol. 2025. PMID: 40151405.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/40151405/",
      "report_type": "Preserved Sato2025 report of final 12-week and intermediate findings for identical beverages with/without DDMP",
      "existence": "Bibliography and preserved summary exist; external original text/registry details remain unread",
      "acquired_read": "Summary read; external materials unread, access not attempted",
      "study_family": "SF01",
      "independent_replication": "The same people, arms, sites, weeks 4/8/12 and sibling sheets are not added as new independent trials/participants.",
      "observed_result": "29.7±7.67 versus 29.7±6.19 a.u., P=0.985; change +8.05±6.85 versus +7.92±5.97, P=0.877; no 95% CI reported",
      "result_level": "Original null comparisons of final 12-week a.u. and baseline change, distinct from positive week 4/8/whole-time findings. ± definition, sites, environment, arm denominators and CIs are unverified; the original no-CI narrative is preserved.",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Local preserved summary",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only acquisition/reading of the complete parent summary is established, not original paper/registry acquisition."
        },
        {
          "material_type": "Abstract",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Only the original citation link is connected. External access, content verification and link testing were not attempted."
        },
        {
          "material_type": "Full paper",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "DOI/PMCID are not supplied; no original full text or external content was newly acquired/read."
        },
        {
          "material_type": "Registration material",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original UMIN000052867 is preserved; it is not NCT. Registry versions/content remain unread and access was not attempted."
        },
        {
          "material_type": "Protocol",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original plans for identical beverages/exposure, sites/environment, final/intermediate outcomes and harms are needed. Existence/public availability are unverified."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original plans for PPS/assignment effects, final/change contrasts, time models/multiplicity and missingness are needed."
        },
        {
          "material_type": "Outcome tables and site/denominator/harm records",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Arm/visit/site, baseline/change, ± definitions, denominators/missingness and detailed harms are needed. No new calculations."
        },
        {
          "material_type": "Funding/conflict-of-interest disclosures",
          "public_status": "External materials unread/needed",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Original disclosures about Nissin York provision, employee/contractor and support roles remain unread."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/40151405/"
        }
      ]
    }
  ],
  "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The same Sato2025 trial/citation links both beverage arms, 220/PPS 213, sites/visits/final/change results and parent/12-week/intermediate sheets. These are not newly added independent trials/participants."
  },
  "history": [
    {
      "date": "2026-10-14",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-14"
}