{
  "title": "Single-ingredient ordinary thiamine (vitamin B1) × Pain relief in painful diabetic peripheral neuropathy",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-05",
  "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; distinguish intervention variants.",
      "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed."
    },
    {
      "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 and link studies and reports; do not omit studies solely because outcomes are unreported.",
      "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed."
    },
    {
      "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": "Fix the outcome and effect of interest, then review randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed."
    },
    {
      "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 effects, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed."
    },
    {
      "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 designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.",
      "review_level": "Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some stored-summary information is verified, but gaps remain in the eligible population, formulation, scale and results",
    "Unverified": "Specified required materials cannot be established within the current stored scope; not an effect of 0, 0 studies worldwide or safety",
    "Review incomplete": "Original-material comparison/search was not performed within the authorized scope",
    "Not reported": "A scope-limited status indicating that the item is not stated in the specific material/section read",
    "Inaccessible": "Used only for materials where access was actually attempted and failed; not assigned to clinical materials in this work",
    "Insufficient evidence meeting the conditions": "Used only after related studies within the defined scope were reviewed and found insufficient to answer the condition; not applied universally in this work",
    "Not applicable": "Does not add optimal-dose, long-term persistence or other clinical-outcome requirements to the selected pain-change question",
    "Conflicting information": "Used when materials for the same question, time and analysis are incompatible upon comparison; not assigned merely because review values differ",
    "Met": "The specified question, scope, attribution and preservation links were verified; establishing a pain effect and certifying full-text reading are checked separately"
  },
  "schema_version": "chamgap-public-criteria-1.0",
  "condition_origin": "Chamgap’s own application conditions",
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Independent claim",
      "question": "Which B1, population and pain question is being checked?",
      "needed": "Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "The exact comparison must be distinguished from related ingredients and deficiency neuropathy.",
      "application_exception": "Benfotiamine, B1+B6 and correction of confirmed deficiency are separate questions.",
      "criterion": "Fix one question by linking the original effect, population, outcome, comparator and empty subclaim list.",
      "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare each candidate's ingredient, population and outcome boundaries with the original question."
    },
    {
      "item_id": "N02",
      "question_type": "Molecule and single ingredient",
      "question": "Was the actual exposure to thiamine alone verified in an eligible result?",
      "needed": "Exact vitamer, salt, single-ingredient identity and actual administration documents",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Ordinary thiamine in the question must not be mistaken for the actual trial formulation.",
      "application_exception": "Do not transfer results for benfotiamine or comparisons that also change B6.",
      "criterion": "Verify the actual molecule and single ingredient in an eligible result from the original administration documents.",
      "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link formulation documents with arm-specific outcomes to examine actual exposure."
    },
    {
      "item_id": "N03",
      "question_type": "Formulation and origin",
      "question": "Were the salt, release form, manufacture and purity of an eligible formulation verified?",
      "needed": "Exact salt, formulation, manufacturing origin, purity, batch and excipients",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Results for different salts, derivatives or products must not be combined as if they concerned the same formulation.",
      "application_exception": "Plant-part classification is not applicable, but gaps in manufacture and formulation remain.",
      "criterion": "Verify the actual product specifications used in the eligible comparison.",
      "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare the formulation specifications and batch with the scope of the corresponding result."
    },
    {
      "item_id": "N04",
      "question_type": "Actual route",
      "question": "Were records of actual oral administration obtained for an eligible trial?",
      "needed": "Actual administration route, adherence and exposure records",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "The oral-route condition in the question must be distinguished from actual study records.",
      "application_exception": "The route specified in the question does not verify an unobtained registry result.",
      "criterion": "Link the eligible result and actual oral administration within the same documents.",
      "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link administration methods and medication records to the original result."
    },
    {
      "item_id": "N05",
      "question_type": "Dose and concurrent B6",
      "question": "Were both the eligible single-ingredient dose and the component amounts in the combination comparison verified?",
      "needed": "Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A comparison that also changes B6 must not be treated as a B1 dose effect.",
      "application_exception": "25 mg+B6 50 mg versus 1 mg+B6 1 mg is an excluded combination comparison.",
      "criterion": "Verify the single-ingredient dose and actual intake separately from each component amount in the combination comparison.",
      "basis": "M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Use arm-specific administration and ingredient tables to examine whether only B1 differs."
    },
    {
      "item_id": "N06",
      "question_type": "Duration",
      "question": "Were treatment and follow-up durations verified in an eligible monotherapy trial?",
      "needed": "Actual treatment, assessment and post-treatment follow-up schedules",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "An arbitrary minimum number of weeks must not replace an unconfirmed duration.",
      "application_exception": "Do not inherit another trial's duration for this question.",
      "criterion": "Verify treatment, assessment and follow-up times for the selected result.",
      "basis": "M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M08 Table 8.2.a, M04 §4.6.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link plans, outcome tables and assessment schedules."
    },
    {
      "item_id": "N07",
      "question_type": "Population selection",
      "question": "Were diagnostic and selection records obtained for adults with painful DPN in an eligible study?",
      "needed": "DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A registry title alone must not establish the actual analysis population.",
      "application_exception": "Confirmed B1-deficiency neuropathy is separate.",
      "criterion": "Link the diagnostic and selection criteria for the actual eligible population with the outcome population.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare selection and baseline tables with the analysis population."
    },
    {
      "item_id": "N08",
      "question_type": "Baseline nutritional status",
      "question": "Were B1 deficiency and baseline status verified in the eligible population?",
      "needed": "Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Deficiency correction must be distinguished from the question of DPN pain without deficiency.",
      "application_exception": "Do not infer deficiency from symptoms alone.",
      "criterion": "Verify actual baseline status and assessment methods in the eligible population.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare tests, diagnosis and arm-specific baseline tables with the outcomes."
    },
    {
      "item_id": "N09",
      "question_type": "Diet and concurrent exposures",
      "question": "Were total intake, concurrent vitamins and usual care verified?",
      "needed": "Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Confounding in comparisons that change vitamins and treatment together must be distinguished.",
      "application_exception": "The B6 change in S22 is not interpreted as a single-ingredient effect.",
      "criterion": "Verify arm-specific concurrent exposures and shared treatment in an eligible comparison.",
      "basis": "M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare intake, medication and concurrent-treatment records with arm-specific results."
    },
    {
      "item_id": "N10",
      "question_type": "Actual comparator",
      "question": "Were matched placebo/no addition and usual care verified for an eligible result?",
      "needed": "Actual comparator composition, schedule, usual care and arm-specific changes",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "The planned comparison in the question must be distinguished from the comparison actually observed.",
      "application_exception": "Do not recast a comparison that changes both B1 and B6 amounts as a matched single-ingredient comparison.",
      "criterion": "Verify the actual comparator and shared care for an eligible result.",
      "basis": "M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link assignment, administration and care records to the original result."
    },
    {
      "item_id": "N11",
      "question_type": "Pain measure",
      "question": "Were the actual pain scale and assessment times verified for an eligible result?",
      "needed": "Patient-reported pain scale, direction, units and baseline/follow-up times",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A registry title or general symptoms must not be converted into a specific pain result.",
      "application_exception": "Do not import the NRS scale from another case.",
      "criterion": "Verify the actual measure and assessment times for the selected patient-reported pain outcome.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link the scale, assessment plan and outcome table to the same population."
    },
    {
      "item_id": "N12",
      "question_type": "Primary outcome and selective reporting",
      "question": "Were the registered/planned primary outcome and actual pain results compared?",
      "needed": "Dated registration, protocol, SAP and locations of the actual results",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A title mentioning pain must not establish it as the prespecified primary outcome.",
      "application_exception": "Failure to obtain the registry body is not conclusive evidence of selective reporting.",
      "criterion": "Verify agreement between the prespecified plan and reported outcomes, times and analyses.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M08 §8.2.2, M15 §15.3.1: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Directly compare the timing of registry/protocol changes with published results."
    },
    {
      "item_id": "N13",
      "question_type": "Design and bias",
      "question": "Were assignment, blinding and analysis methods verified for an eligible comparison?",
      "needed": "Randomization, concealment, blinding, planned analyses and change records",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Unobtained methods must not be scored as invented defects.",
      "application_exception": "Do not replace the original blank bias value with a new B grade.",
      "criterion": "Verify methods and material limitations for the actual eligible comparison.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M08 §8.1–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare plans, methods and results, distinguishing unconfirmed information from verified defects."
    },
    {
      "item_id": "N14",
      "question_type": "Denominators and missing data",
      "question": "Were the actual analysis denominator and missing-data handling verified for the pain result?",
      "needed": "Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "The assigned population must not replace the analysis denominator.",
      "application_exception": "A path to a numerical-data file does not mean that file was actually read for this work.",
      "criterion": "Verify denominators and missing-data handling for the specific outcome, time and analysis.",
      "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; M08 Table 8.2.a, M04 §4.6.3: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link participant flow, arm-specific results and analysis plans."
    },
    {
      "item_id": "N15",
      "question_type": "Effect and interval",
      "question": "Were the between-group pain effect and uncertainty interval verified for B1 alone?",
      "needed": "Eligible between-group effect, units, analysis model, denominator and CI",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "An unverified effect must not become an effect of 0 or the effect of another combination.",
      "application_exception": "Do not calculate a new effect size from P values, within-group changes or combination results.",
      "criterion": "Verify the estimate and interval for the selected single-ingredient comparison from actual results.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M15 §15.3.1–15.3.3: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare between-group results with the model, denominator and time, and record interpretive limits."
    },
    {
      "item_id": "N16",
      "question_type": "Clinical magnitude",
      "question": "Were meaningful differences and responder data obtained for the pain measure?",
      "needed": "Scale-specific clinical meaning, responder definition, person denominator and period",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Do not invent a common MCID or NNT while the specific scale is unconfirmed.",
      "application_exception": "Do not invent an event table for a continuous outcome.",
      "criterion": "Verify clinical-magnitude information corresponding to the actual scale and result.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4: internal application; M15 §15.3.1–15.3.3: internal application; M03 §3.2.4: internal boundary for expanded claims",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link measurement validity and responder definitions with the actual comparative results."
    },
    {
      "item_id": "N17",
      "question_type": "Registry candidate",
      "question": "Was the actual result body obtained for NCT00279266?",
      "needed": "Original registry body, change history, results and linked papers",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A candidate registry entry must be distinguished from actual result acquisition.",
      "application_exception": "Do not turn historical access failure into a current connection failure or proof of no results.",
      "criterion": "Separately verify existence, acquisition and content of the actual registry body and results.",
      "basis": "M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M04 §4.5–4.6: material collection/selection principles; separating access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "If a later update is authorized, compare original locations, times and changes for the registration and linked results."
    },
    {
      "item_id": "N18",
      "question_type": "Combination exclusion",
      "question": "Was the Abbas–Swai comparison excluded from the effect of B1 alone?",
      "needed": "Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A comparison that also changes other ingredients must not be mistaken for a single-ingredient causal effect.",
      "application_exception": "Do not erase related human research as nonexistent.",
      "criterion": "Link actual combination amounts and the original exclusion reason to the same material.",
      "basis": "M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare arm-specific administration tables with the scope of the results."
    },
    {
      "item_id": "N19",
      "question_type": "Reports and study families",
      "question": "Were the actual study and participant-family relationships between the two reports verified?",
      "needed": "Link reports to registration/study families, then outcomes, times and analyses",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Bibliographic counts must not become counts of eligible studies or unique participants.",
      "application_exception": "Do not count unconfirmed links or duplicates as verified replication.",
      "criterion": "Verify actual registration, study and participant relationships from original materials, distinguishing unconfirmed links.",
      "basis": "M04 §4.6.1–4.6.2 on distinguishing studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Link registration, paper, participant and time identities to examine duplication."
    },
    {
      "item_id": "N20",
      "question_type": "Current reading scope",
      "question": "Were stored summaries, unread external materials and historical access distinguished?",
      "needed": "Actual acquisition, reading, historical access level, locations and dates for each material",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Providing a URL must not be promoted to reading the original full text.",
      "application_exception": "Registry opening-page access and indexed author-abstract records remain historical.",
      "criterion": "Distinguish and link actual reading of the stored local summary from current external non-attempt/non-reading.",
      "basis": "M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "If later authorized, record actual source bytes, access date and exact location for each material."
    },
    {
      "item_id": "N21",
      "question_type": "Cutoff date and search scope",
      "question": "Were the original cutoff, search limitations and scope of this conversion distinguished?",
      "needed": "Search cutoff, original review date, current summary-review date and actual work scope",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "A conversion of stored materials must not be exaggerated into a new exhaustive literature search.",
      "application_exception": "A search-log path alone does not establish that the log was read for this work.",
      "criterion": "Separate the original cutoff and search scope from the lack of current external work.",
      "basis": "M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "In an authorized update, compare actual search logs with subsequent materials and corrections."
    },
    {
      "item_id": "N22",
      "question_type": "Replication and independence",
      "question": "Was evidence of independent replication verified for the exact single-ingredient pain comparison?",
      "needed": "Eligible replication results, teams, funding and participant/data overlap",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Related research must be distinguished from replication of the single-ingredient claim.",
      "application_exception": "The individual manuscripts for benfotiamine 544 and general nerve function 162 were not read for this work.",
      "criterion": "Verify eligible replication and independent identities for the same ingredient, population and outcome.",
      "basis": "M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare outcomes, study families, authors/funding and data overlap."
    },
    {
      "item_id": "N23",
      "question_type": "Funding and conflicts of interest",
      "question": "Were funding, author roles and conflicts of interest obtained for the eligible result?",
      "needed": "Original funding, affiliations, roles, COI and data independence",
      "role": "Supplementary; required for independence claims",
      "role_reason": "Unconfirmed information must not become proof of non-involvement or verified bias.",
      "application_exception": "Do not transfer funding information from another study.",
      "criterion": "Directly verify declarations and roles for the eligible result.",
      "basis": "Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare original funding/COI declarations with the actual study and data relationships."
    },
    {
      "item_id": "N24",
      "question_type": "Preserving the original judgment",
      "question": "Were the original ?, blank values and bounded eligible-human-result-unverified flag preserved?",
      "needed": "Original grade, score, axes, judgment scope and revision policy",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Checklist status must not be confused with the existing clinical grade or a new certification.",
      "application_exception": "Document-quality A and grade ? are separate; they do not mean no effect or 0 studies worldwide.",
      "criterion": "Preserve original values, blanks, false values, empty arrays and judgment scope without conversion.",
      "basis": "M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare the original stored-manuscript bytes with each linked location to verify display scope."
    },
    {
      "item_id": "N25",
      "question_type": "Clinical and biochemical boundaries",
      "question": "Was the pain question distinguished from circulating vitamers?",
      "needed": "Question boundaries between patient symptoms/function and biochemical measures",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Biochemical changes must not replace a pain effect.",
      "application_exception": "Preserve the blank biochemical value and the confirmed information status.",
      "criterion": "Verify the distinction between the original patient symptom/function question and biochemistry.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M03 §3.2.4: internal boundary for expanded claims",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Examine candidate measures separately from actual patient outcomes."
    },
    {
      "item_id": "N26",
      "question_type": "Safety",
      "question": "Were harms and discontinuation data obtained for the same single-ingredient product, population and period?",
      "needed": "AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations",
      "role": "Supplementary; required for safety claims",
      "role_reason": "Tolerability of other B-vitamin combinations must not be transferred to B1 alone.",
      "application_exception": "Do not change the original unknown safety status into a new safety grade.",
      "criterion": "Verify actual harms, collection scope and denominators for that single-ingredient exposure.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M19 §19.1.2–19.2.4: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare exposure, harm collection, discontinuation and follow-up records."
    },
    {
      "item_id": "N27",
      "question_type": "Assay interference and drug interactions",
      "question": "Is there a separate verification scope for assay interference and concurrent drugs?",
      "needed": "Actual assay/drug exposure, interference and interaction information, and work scope",
      "role": "Supplementary; required for interpreting interference or interactions",
      "role_reason": "Not conducting a separate search must not be interpreted as no impact.",
      "application_exception": "Do not turn an unperformed search into current access failure or clinical safety.",
      "criterion": "Verify materials and review scope supporting the particular interference or interaction claim.",
      "basis": "M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M19 §19.1.2–19.2.4: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "In an authorized extension, separately review actual assay and concurrent-exposure materials."
    },
    {
      "item_id": "N28",
      "question_type": "Long-term and optimal-dose extensions",
      "question": "Does the current pain question also include optimal-dose and post-treatment persistence claims?",
      "needed": "Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions",
      "role": "Supplementary; required for optimal-dose or long-term extensions",
      "role_reason": "A narrow question must not require every study of expanded claims.",
      "application_exception": "Do not turn unconfirmed duration into a verified long-term effect.",
      "criterion": "Distinguish the fixed question from additional optimal-dose or long-term persistence claims.",
      "basis": "M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "When an extension is requested, review direct dose comparisons and post-treatment/long-term follow-up as separate questions."
    },
    {
      "item_id": "N29",
      "question_type": "Deficiency and other-outcome extensions",
      "question": "Does this table include correction of deficiency neuropathy or other nerve outcomes?",
      "needed": "Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison",
      "role": "Supplementary; required for deficiency or other-outcome extensions",
      "role_reason": "Questions with different populations or outcomes must not be merged into one completed claim.",
      "application_exception": "Do not erase related research or create a new judgment that research does not exist.",
      "criterion": "Distinguish the selected population/outcome from separate expanded questions.",
      "basis": "M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed; M03 §3.2.4: internal boundary for expanded claims",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "For an extension, directly review the corresponding diagnosis/outcome materials as a separate independent question."
    },
    {
      "item_id": "N30",
      "question_type": "Updates and corrections",
      "question": "Were updates for new evidence, access or corrections linked with preservation of previous originals?",
      "needed": "Triggers, verified materials, reasons for changes, dates and previous originals/judgments",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Future update triggers must not become a waiting condition for initial publication.",
      "application_exception": "Condition changes are applied only after a separate new version is frozen.",
      "criterion": "Link the original revision policy with uncertainty disclosure, original preservation and row-level updates.",
      "basis": "M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare the identity, location and hashes of new materials/corrections separately from change decisions."
    },
    {
      "item_id": "N31",
      "question_type": "Contrary and conflicting results",
      "question": "Were all verified related materials and the original limits on refutation preserved?",
      "needed": "Roles, results and exclusion reasons for both reports, and the original scope of refutation",
      "role": "Required for the selected B1-only pain comparison",
      "role_reason": "Related human research must not be erased, nor results for other ingredients converted into refutation of the same question.",
      "application_exception": "Unverified eligible monotherapy results do not mean no effect or repeated refutation.",
      "criterion": "Preserve both current materials and all verified findings and limitations with their locations, regardless of direction.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3: status distinctions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application",
      "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified",
      "proposed_research": "Compare original roles, results and exclusion reasons against the same single-ingredient question."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-31"
}