{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2979-s1", "verdict_number": "2979", "title": "DDMP lactic-acid-bacteria beverage × Moisture change at weeks 4 and 8", "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": "220 healthy Japanese adults with dry skin were randomized, and 213 protocol-compliant participants were analyzed. Group- and visit-specific denominators, withdrawals and exclusions, eligibility, measurement sites and conditions are unverified.", "intervention": "The study formulation was a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. Its full ingredients, strains and viability, product and batch identity, and manufacturing specifications are unverified. The findings are not transferred to general probiotics, other beverages or separate DDMP formulations.", "dose": "Only the original study identity of 2.2 mg DDMP in a 65 mL beverage and 12-week follow-up is retained. Actual daily frequency, cumulative exposure and adherence are unverified. No new consumption or care instructions or conversions are produced.", "comparator": "An otherwise identical lactic-acid-bacteria beverage without DDMP. The original description of a double-blind randomized parallel comparison is retained. Ingredient and sensory matching, allocation and blinding procedures, and concurrent skin care are unverified.", "endpoint": "Intermediate changes from baseline were +4.28 versus −2.09 at week 4 (P<0.001) and +8.47 versus +5.17 at week 8 (P=0.002). These are distinguished from final week-12 absolute values of 29.7±7.67 versus 29.7±6.19 a.u. (P=0.985) and changes of +8.05±6.85 versus +7.92±5.97 (P=0.877). The whole-time mixed-model P<0.001 concerns a trajectory difference, not a benefit at week 12. No new differences, CIs, effects or grades are calculated.", "duration": "Intermediate changes at weeks 4 and 8 and the prespecified final week-12 primary endpoint. Persistence beyond 12 weeks, other skin or clinical outcomes, and effects in other populations or products are unverified.", "excluded_extensions": [ "Calculating new between-group differences, ratios, CIs or response rates from +4.28 versus −2.09 at week 4 or +8.47 versus +5.17 at week 8", "Recasting positive intermediate visits or a whole-time mixed-model P<0.001 as prespecified final week-12 efficacy or sustained benefit", "Combining final absolute values with changes from baseline, skin sites or measurement conditions, or visit-specific denominators", "Treating P=0.985 or P=0.877 as proof of a zero effect, equivalence or exclusion of meaningful benefit", "Adding the 220 randomized and 213 analyzed participants, groups, visits, skin sites, references or related sheets as new independent trials or participants", "Transferring the DDMP-versus-no-DDMP comparison within the same beverage to all DDMP formulations, probiotics or general beverages, or other skin or clinical effects", "Inheriting parent values/axes and historical cross-checks as subclaim scores, current review or original-source reading", "New calculations, hypothetical values, effects/CIs, grades, independence certification, drink/extract/product intake, skin/sleep management or treatment-substitution instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected intermediate-visit question and original grade", "needed": "Distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict", "role": "Required", "role_reason": "This item distinguishes distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for distinction between the original wording and grade for weeks 4 and 8 and the parent final-visit verdict must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes the original question's scope at each visit. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected subclaim is “Moisture change at weeks 4 and 8”, grade C, recording positive intermediate findings and loss of the difference by final week 12. Subclaim score, status and axes are absent. Parent grade D with 28 points is retained as the final week-12 verdict context.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Subclaim score, status and axes are absent and are not filled with parent values. Review of the existing content is incomplete.", "missingness": "Subclaim score, status and axes are absent and are not filled with parent values.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected question and parent verdict, and user corrections" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Population, recruitment and skin condition", "needed": "Actual participants' ages, eligibility, dry-skin definition and recruitment conditions", "role": "Required", "role_reason": "This item distinguishes actual participants' ages, eligibility, dry-skin definition and recruitment conditions to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for actual participants' ages, eligibility, dry-skin definition and recruitment conditions must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that compares the same formulation with explicitly defined population criteria. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "220 healthy Japanese adults with dry skin were randomized. The original summary does not record intermediate-visit effects in other age groups or skin-disease populations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Detailed eligibility, age distribution, sex, diagnostic or measurement criteria for skin condition, and baseline environmental conditions are unverified. Review of the existing content is incomplete.", "missingness": "Detailed eligibility, age distribution, sex, diagnostic or measurement criteria for skin condition, and baseline environmental conditions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, recruitment and baseline-characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of the study beverage", "needed": "DDMP content, beverage formulation, other ingredients and product identity", "role": "Required", "role_reason": "This item distinguishes DDMP content, beverage formulation, other ingredients and product identity to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for DDMP content, beverage formulation, other ingredients and product identity must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes formulation effects from attribution to individual ingredients. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The intervention was a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. This study exposure is not recast as evidence for general lactic-acid bacteria or probiotics, other beverages, or all DDMP formulations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Strains, viability, full ingredients and manufacturing specifications, and correspondence across formulations are unverified. Review of the existing content is incomplete.", "missingness": "Strains, viability, full ingredients and manufacturing specifications, and correspondence across formulations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Ingredient, manufacturing and identity records for the study and control beverages" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Identical-beverage control without DDMP", "needed": "Actual intervention-control differences and ingredient or contact matching", "role": "Required", "role_reason": "This item distinguishes actual intervention-control differences and ingredient or contact matching to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for actual intervention-control differences and ingredient or contact matching must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that clearly specifies the differences from the control. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record describes a control beverage that lacked only DDMP and was otherwise the same lactic-acid-bacteria beverage. This compares the presence and absence of DDMP within that beverage, not consumption versus non-consumption of a general beverage.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Manufacturing and ingredient matching, taste and appearance, and participants' ability to distinguish the beverages are unverified. Review of the existing content is incomplete.", "missingness": "Manufacturing and ingredient matching, taste and appearance, and participants' ability to distinguish the beverages are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control ingredient, sensory and manufacturing matching records" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Random allocation and concealment", "needed": "Sequence generation, allocation concealment and implementation", "role": "Required", "role_reason": "This item distinguishes sequence generation, allocation concealment and implementation to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for sequence generation, allocation concealment and implementation must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01 is described as a double-blind randomized identical-beverage placebo-controlled parallel trial. The design label is not treated as verification of the entire allocation procedure.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Sequence generation, concealment, who implemented allocation, and group-specific baseline balance are unverified. Review of the existing content is incomplete.", "missingness": "Sequence generation, concealment, who implemented allocation, and group-specific baseline balance are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Randomization, allocation-concealment and baseline tables" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Blinding and assessors", "needed": "Actual blinding of participants, assessors and analysts and its maintenance", "role": "Required", "role_reason": "This item distinguishes actual blinding of participants, assessors and analysts and its maintenance to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for actual blinding of participants, assessors and analysts and its maintenance must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that specifies assessor blinding and measurement conditions. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original double-blind label is retained. It is not stated that blinding of stratum-corneum moisture assessors and analysts, or its maintenance, was fully verified.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Who was blinded, blinding success, unblinding timing and assessment conditions are unverified. Review of the existing content is incomplete.", "missingness": "Who was blinded, blinding success, unblinding timing and assessment conditions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding procedures and assessor-role records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "12-week exposure and adherence", "needed": "Study exposure, consumption records, group-specific adherence and withdrawal criteria", "role": "Required", "role_reason": "This item distinguishes study exposure, consumption records, group-specific adherence and withdrawal criteria to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for study exposure, consumption records, group-specific adherence and withdrawal criteria must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes exposure from the analysis population. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The source records 12-week follow-up and analysis of protocol-compliant participants. The 2.2 mg/65 mL specification is retained only as the beverage identity; no new consumption instructions are produced.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Daily frequency, actual cumulative exposure, adherence and reasons for protocol violations are unverified. Review of the existing content is incomplete.", "missingness": "Daily frequency, actual cumulative exposure, adherence and reasons for protocol violations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure, adherence and protocol-compliance criteria" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Skin sites and measurement environment", "needed": "Skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit", "role": "Required", "role_reason": "This item distinguishes skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for skin sites, instruments, temperature and humidity, acclimatization and measurement conditions at each visit must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that specifies measurement conditions at each visit. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original endpoint is stratum-corneum moisture. The summary is not supplemented with an unsupported assertion that skin sites or measurement conditions remained identical.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the preserved summary. Measurement sites, left-right or repeated measurements, instruments, temperature and humidity, premeasurement conditions and assessors are unverified. Review of the existing content is incomplete.", "missingness": "Measurement sites, left-right or repeated measurements, instruments, temperature and humidity, premeasurement conditions and assessors are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement manuals and site- or environment-specific results" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Baseline, units and definition of change", "needed": "Units and calculation definitions for absolute moisture values and changes from baseline", "role": "Required", "role_reason": "This item distinguishes units and calculation definitions for absolute moisture values and changes from baseline to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for units and calculation definitions for absolute moisture values and changes from baseline must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that reports absolute values and change estimates separately. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Final week-12 values are preserved in a.u., while intermediate visits are described as changes from baseline. Absolute values and changes are not combined as the same outcome.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Group-specific baseline values, the exact change calculation, and intermediate absolute values and standard deviations are unverified. Review of the existing content is incomplete.", "missingness": "Group-specific baseline values, the exact change calculation, and intermediate absolute values and standard deviations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline and visit-specific absolute-value or change tables and analysis definitions" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Moisture change at week 4", "needed": "Week-4 changes by group, comparison and uncertainty", "role": "Required", "role_reason": "This item distinguishes week-4 changes by group, comparison and uncertainty to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for week-4 changes by group, comparison and uncertainty must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes week-4 changes from final effects. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records changes from baseline at week 4 of +4.28 versus −2.09, P<0.001. No new between-group difference, ratio or CI is calculated, and this is not recast as a sustained 12-week effect.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Week-4 absolute values, SDs or SEs, 95% CI, visit-specific analysis denominators and the exact model are unverified. Review of the existing content is incomplete.", "missingness": "Week-4 absolute values, SDs or SEs, 95% CI, visit-specific analysis denominators and the exact model are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Week-4 results, denominators, analysis and CI records" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Moisture change at week 8", "needed": "Week-8 changes by group, comparison and uncertainty", "role": "Required", "role_reason": "This item distinguishes week-8 changes by group, comparison and uncertainty to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for week-8 changes by group, comparison and uncertainty must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes replication of intermediate changes from persistence at the final visit. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records changes from baseline at week 8 of +8.47 versus +5.17, P=0.002. No new difference, CI or individual improvement rate is produced.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Week-8 absolute values, SDs or SEs, 95% CI, visit-specific denominators and the exact analysis specification are unverified. Review of the existing content is incomplete.", "missingness": "Week-8 absolute values, SDs or SEs, 95% CI, visit-specific denominators and the exact analysis specification are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Week-8 results, denominators, analysis and CI records" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Final week-12 absolute moisture values", "needed": "Absolute values, units and P for the prespecified final primary endpoint", "role": "Required", "role_reason": "This item distinguishes absolute values, units and P for the prespecified final primary endpoint to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for absolute values, units and P for the prespecified final primary endpoint must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.3 and M15 §15.3.1–15.3.3: status separation is in-house; M15 §15.3.1–15.3.3: in-house application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that adequately reports the final-visit effect and uncertainty. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Week-12 values were 29.7±7.67 versus 29.7±6.19 a.u., P=0.985. The final null finding is retained alongside the positive intermediate findings; P is not used as proof of an exactly zero effect or equivalence.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. The 95% CI and the range needed to exclude a clinically meaningful benefit are unverified. Review of the existing content is incomplete.", "missingness": "The 95% CI and the range needed to exclude a clinically meaningful benefit are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Final absolute-value estimates, CIs and analysis tables" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Final week-12 change values", "needed": "Distinction between final changes from baseline and absolute values", "role": "Required", "role_reason": "This item distinguishes distinction between final changes from baseline and absolute values to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for distinction between final changes from baseline and absolute values must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that reports changes and final absolute values separately. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Week-12 changes were +8.05±6.85 versus +7.92±5.97, P=0.877. These estimates are distinguished from final absolute values with P=0.985.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. The change estimate's 95% CI and the exact between-group effect and clinical importance are unverified. Review of the existing content is incomplete.", "missingness": "The change estimate's 95% CI and the exact between-group effect and clinical importance are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline adjustment, change estimates and CIs" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Whole-time mixed model", "needed": "Specification of the whole-trajectory test and individual-visit effects", "role": "Required", "role_reason": "This item distinguishes specification of the whole-trajectory test and individual-visit effects to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for specification of the whole-trajectory test and individual-visit effects must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes the whole trajectory from final and intermediate contrasts. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original explanation states that the whole-time mixed-model P<0.001 concerns differing patterns across visits. It is not recast as a positive week-12 effect or a sustained benefit at every visit.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Model terms, repeated-measure covariance, interaction or main effects, prespecified plans and individual contrasts are unverified. Review of the existing content is incomplete.", "missingness": "Model terms, repeated-measure covariance, interaction or main effects, prespecified plans and individual contrasts are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Mixed-model and repeated-measure plans and results, and visit-specific contrasts" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Primary-endpoint and intermediate-result hierarchy", "needed": "Hierarchy of the prespecified final week-12 primary endpoint and intermediate visits", "role": "Required", "role_reason": "This item distinguishes hierarchy of the prespecified final week-12 primary endpoint and intermediate visits to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for hierarchy of the prespecified final week-12 primary endpoint and intermediate visits must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that explicitly specifies the final and intermediate endpoint hierarchy. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The prespecified primary endpoint is stratum-corneum moisture at final week 12. Positive weeks 4 and 8 are recorded but are not promoted to the primary endpoint or used to replace the final conclusion.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Prespecification of week-4 and week-8 analyses, secondary hierarchy, testing order and analysis changes are unverified. Review of the existing content is incomplete.", "missingness": "Prespecification of week-4 and week-8 analyses, secondary hierarchy, testing order and analysis changes are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit and hierarchy records in the registration, protocol and SAP" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Unreported CIs and meaningful benefit", "needed": "Exact effects, CIs and importance thresholds", "role": "Required", "role_reason": "This item distinguishes exact effects, CIs and importance thresholds to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for exact effects, CIs and importance thresholds must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that specifies CIs and importance thresholds. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that the paper reported no 95% CI and that a meaningful benefit therefore cannot be excluded. No new CI, equivalence margin or response threshold is produced.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Visit-specific CIs, prespecified importance thresholds and effect precision are unverified. Review of the existing content is incomplete.", "missingness": "Visit-specific CIs, prespecified importance thresholds and effect precision are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables, CIs and prespecified importance thresholds" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "220 randomized and 213 in PPS", "needed": "Distinction between randomized and analyzed populations and group- or visit-specific denominators", "role": "Required", "role_reason": "This item distinguishes distinction between randomized and analyzed populations and group- or visit-specific denominators to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for distinction between randomized and analyzed populations and group- or visit-specific denominators must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M08 §8.1–8.2.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that reports the full randomized population and PPS results together. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original counts of 220 randomized and 213 protocol-compliant participants analyzed are retained. The counts are not added together or treated as confirmation of every visit denominator or a complete ITT analysis.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Group-specific PPS, valid visit-specific denominators, FAS or ITT results and exclusion criteria are unverified. Review of the existing content is incomplete.", "missingness": "Group-specific PPS, valid visit-specific denominators, FAS or ITT results and exclusion criteria are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, analysis-population and visit-specific denominator tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Withdrawal, missing data and analysis exclusions", "needed": "Reasons for withdrawal, missing data, group-specific effects and handling", "role": "Required", "role_reason": "This item distinguishes reasons for withdrawal, missing data, group-specific effects and handling to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for reasons for withdrawal, missing data, group-specific effects and handling must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes the effects of missingness and nonadherence. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that the primary analysis used 213 protocol-compliant participants rather than all 220 randomized. No new exclusion count is calculated or missing-data impact established.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the preserved summary. Reasons, timing and group patterns of missingness, withdrawal or exclusion, and adjustment or sensitivity results are unverified. Review of the existing content is incomplete.", "missingness": "Reasons, timing and group patterns of missingness, withdrawal or exclusion, and adjustment or sensitivity results are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant-flow diagrams, missing-data handling and sensitivity results" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Within-group change and between-group comparison", "needed": "Group correspondence and within- or between-group change estimands", "role": "Required", "role_reason": "This item distinguishes group correspondence and within- or between-group change estimands to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for group correspondence and within- or between-group change estimands must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that clearly reports within- and between-group estimands. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Group-specific changes at weeks 4, 8 and 12 and their P values are retained exactly as in the preserved summary. Within-group changes alone are not used to create a placebo-relative difference or a new numerical effect.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Exact between-group contrasts, baseline adjustment, model-specific estimates and whether within-group tests were used are unverified. Review of the existing content is incomplete.", "missingness": "Exact between-group contrasts, baseline adjustment, model-specific estimates and whether within-group tests were used are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result tables, group correspondence and contrast definitions" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "UMIN identifier and reading of prespecified plans", "needed": "Actual verification scope for registration, protocol, SAP and change history", "role": "Required", "role_reason": "This item distinguishes actual verification scope for registration, protocol, SAP and change history to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for actual verification scope for registration, protocol, SAP and change history must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that links prespecified plans with the analyses actually performed. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved registration identifier is UMIN000052867. The UMIN number is retained in its original form, and no claim is made that the external registration has been read.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Registration identity and date, prerecruitment plans, visit hierarchy, changes, and full protocol or SAP text have not been read. Review of the existing content is incomplete.", "missingness": "Registration identity and date, prerecruitment plans, visit hierarchy, changes, and full protocol or SAP text have not been read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "UMIN registry history, protocol and SAP" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Multiple visits, sites and tests", "needed": "Multiplicity specification for intermediate visits, skin sites and analyses", "role": "Required", "role_reason": "This item distinguishes multiplicity specification for intermediate visits, skin sites and analyses to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for multiplicity specification for intermediate visits, skin sites and analyses must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort and outcome linkage is an internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes multiple-visit findings from the final primary endpoint. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Positive weeks 4 and 8, the final week-12 null finding and the whole-time model are different analyses of the same trial. Multiple P values are not counted as independent replications or overall success.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. The total number of tests, site or visit selection, adjustments and prespecified analysis order are unverified. Review of the existing content is incomplete.", "missingness": "The total number of tests, site or visit selection, adjustments and prespecified analysis order are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Multiplicity plans and complete result tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Concurrent skin care, season and lifestyle", "needed": "Group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records", "role": "Required", "role_reason": "This item distinguishes group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for group-specific concurrent exposures, lifestyle, seasonal conditions and moisturizer or other care records must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that explicitly specifies concurrent conditions. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The source scope is an identical-beverage control and 12-week follow-up. It is not supplemented with a claim that other skin care, climate, diet or lifestyle conditions were completely identical.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the preserved summary. Concurrent moisturizing or care, lifestyle, season or environment, concomitant medication and analyses of differences are unverified. Review of the existing content is incomplete.", "missingness": "Concurrent moisturizing or care, lifestyle, season or environment, concomitant medication and analyses of differences are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent-exposure, environmental and lifestyle records and analyses" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Provision of study and placebo beverages", "needed": "Manufacturer product support and scope of provision", "role": "Required", "role_reason": "This item distinguishes manufacturer product support and scope of provision to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for manufacturer product support and scope of provision must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A proposed follow-up trial disclosing support roles; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original record states that Nissin York supplied the study and placebo beverages. Product provision is not recast as absence of monetary funding or verification of an independent trial.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Provision agreements, support scope, product-quality or manufacturing records and influence on decisions are unverified. Review of the existing content is incomplete.", "missingness": "Provision agreements, support scope, product-quality or manufacturing records and influence on decisions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product-support and provision agreements or disclosures" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Employee authors and contract organization", "needed": "Author affiliations and roles of the company and contract organization", "role": "Required", "role_reason": "This item distinguishes author affiliations and roles of the company and contract organization to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for author affiliations and roles of the company and contract organization must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that separately discloses company and contract-organization roles. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript's affiliations are retained: T.S., M.T. and S.S. at the Nissin York Development Research Institute, and M.M. at M&I Science. Affiliations alone do not verify all research roles or conflicts of interest.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Specific roles and independence in design, analysis, data management, writing and publication decisions are unverified. Review of the existing content is incomplete.", "missingness": "Specific roles and independence in design, analysis, data management, writing and publication decisions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author contributions, affiliations, COI and contract records" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Public funding, writing and publication costs", "needed": "Item-specific reporting of funding, writing and publication support", "role": "Required", "role_reason": "This item distinguishes item-specific reporting of funding, writing and publication support to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for item-specific reporting of funding, writing and publication support must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that separately discloses each support category. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original summary states that separate public funding, medical-writing and publication costs were not reported. Nonreporting is not judged to establish an absence of support or all conflicts of interest.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Full original funding, medical-writing, publication-cost and other support or COI disclosures have not been read. Review of the existing content is incomplete.", "missingness": "Full original funding, medical-writing, publication-cost and other support or COI disclosures have not been read.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, support, medical-writing, publication-cost and COI disclosures" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Same trial and intermediate or final results", "needed": "Report-to-trial, visit, site and denominator relationships and independent replication", "role": "Required", "role_reason": "This item distinguishes report-to-trial, visit, site and denominator relationships and independent replication to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for report-to-trial, visit, site and denominator relationships and independent replication must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that independently compares the same final and intermediate outcome specifications. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Weeks 4, 8 and 12 in S01 Sato2025 concern one report and the same randomized-population and PPS context. Visits, skin sites, references and related sheets are not added as new independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Independent replication reports under the same conditions and totals of unique trials or participants are not established. Review of the existing content is incomplete.", "missingness": "Independent replication reports under the same conditions and totals of unique trials or participants are not established.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cohort or protocol relationships between reports and original independent-trial reports" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Persistence and other formulations or skin outcomes", "needed": "Distinction between intermediate changes, sustained effects and other skin or clinical outcomes", "role": "Required", "role_reason": "This item distinguishes distinction between intermediate changes, sustained effects and other skin or clinical outcomes to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for distinction between intermediate changes, sustained effects and other skin or clinical outcomes must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundaries; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes persistence from applicability across formulations and populations. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records that positive findings at weeks 4 and 8 were not maintained at the final visit. These are not extended to other skin functions or diseases, general products or sustained long-term efficacy.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Other skin endpoints, follow-up beyond 12 weeks and direct comparisons in other populations or formulations are unverified. Review of the existing content is incomplete.", "missingness": "Other skin endpoints, follow-up beyond 12 weeks and direct comparisons in other populations or formulations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up, other-endpoint and formulation-specific direct-trial records" }, { "item_id": "N28", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Original safety record and scope", "needed": "12-week safety collection, denominators and frequencies, and rare or long-term harms", "role": "Supplementary", "role_reason": "This item distinguishes 12-week safety collection, denominators and frequencies, and rare or long-term harms to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Complements safety-data gaps for the selected subclaim. Intermediate/final skin hydration, self-reported sleepiness or parent cautionary wording are not used to judge safety or create harm-incidence estimates/new use instructions.", "criterion": "Relevant source data and analysis details for 12-week safety collection, denominators and frequencies, and rare or long-term harms must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that specifies harm collection and the scope of longer-term or other-population evidence. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original parent safety label is Good, and the manuscript records no reported serious safety signal attributed to the study beverage over 12 weeks. This is not recast as absence of all harms or verification of safety for other products or durations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Adverse-event types, collection and adjudication, group-specific denominators and frequencies, discontinuation, and rare or long-term harms are unverified. Review of the existing content is incomplete.", "missingness": "Adverse-event types, collection and adjudication, group-specific denominators and frequencies, discontinuation, and rare or long-term harms are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, collection methods and discontinuation or follow-up records" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Parent/subclaim, bilingual text and history", "needed": "Separate preservation of original values, axes, reference date and correction or verification statements", "role": "Required", "role_reason": "This item distinguishes separate preservation of original values, axes, reference date and correction or verification statements to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for separate preservation of original values, axes, reference date and correction or verification statements must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes original values and history from application of new updates. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent D28, B/S/R1/I0/E0/B1/C0, three false flags and blank override reasons are retained alongside the selected subclaim's grade C and note. Korean and English texts, 2026-08-26, empty correction and deliberation records, and historical cross-checking are not a current review or a subclaim score.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. Subclaim score, status and axes are absent from the source. No new score, axes or completed review are created. Review of the existing content is incomplete.", "missingness": "Subclaim score, status and axes are absent from the source. No new score, axes or completed review are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original corrections, versions and user correction comments" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Summary reading, external materials and links", "needed": "Actual reading scope and access status of original articles, registration, plans and support records", "role": "Required", "role_reason": "This item distinguishes actual reading scope and access status of original articles, registration, plans and support records to connect the evidence needed for the selected question with the evidence currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source data and analysis details for actual reading scope and access status of original articles, registration, plans and support records must be provided, with unverified points identified. Preserved wording is linked here; review of the existing content is incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A preserved proposal for follow-up research that distinguishes the timing and scope of acquired material when updating. No new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete preserved summary and references were used for production, and source links are retained. Original articles, registration, protocol, SAP and support or COI materials have not been read or accessed. No separate external-link test was performed.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded. Detailed source material has not been read, and review of the existing content is incomplete. The content and actual accessibility of external original articles, plans and COI materials are unverified. Review of the existing content is incomplete.", "missingness": "The content and actual accessibility of external original articles, plans and COI materials are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External original articles, registration, protocol, SAP and support records, or user input" } ], "reports": [ { "report_id": "S01", "title": "Sato T et al. 2025", "url": "https://pubmed.ncbi.nlm.nih.gov/40151405/", "report_type": "Double-blind randomized identical-beverage placebo-controlled parallel trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2979-SATO-2025", "independent_replication": null, "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; 95% CI not reported. Changes from baseline were positive at week 4, +4.28 versus −2.09 (P<0.001), and week 8, +8.47 versus +5.17 (P=0.002). The difference disappeared by week 12, +8.05 versus +7.92 (P=0.877). A whole-time mixed-model P<0.001 describes different patterns across visits, not a positive week-12 effect.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Sato2025 is one parallel-trial report involving 220 healthy Japanese adults with dry skin randomized and 213 protocol-compliant participants analyzed. It compared a 65 mL beverage containing 2.2 mg DDMP with an otherwise identical beverage without DDMP for 12 weeks. Changes from baseline at week 4 (+4.28 versus −2.09, P<0.001) and week 8 (+8.47 versus +5.17, P=0.002) are distinguished from final week-12 absolute values (29.7±7.67 versus 29.7±6.19 a.u., P=0.985), changes (+8.05±6.85 versus +7.92±5.97, P=0.877), and the whole-time mixed-model P<0.001. Positive intermediate findings neither replace the prespecified final primary endpoint nor establish sustained benefit. The same groups, visits, skin sites, denominators, references and related sheets are not new independent trials or participants. Report entries are not totals of unique clinical trials, participants or independent replications; no new totals or independence certification are produced." }, "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 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }