{
  "title": "Oral pantothenic acid (vitamin B5) as the sole active ingredient × Reduction of FSS fatigue severity in adults with unexplained/nonspecific persistent fatigue",
  "criteria_version": "NGM-v3101-SOLE-B5-NONSPECIFIC-PERSISTENT-FATIGUE-FSS-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, and distinguish variations of the intervention.",
      "review_level": "Reuse of preserved methodological principles/version from 1585 and actual original-byte copies of 5 HTML files; not new reading of methodological full texts or application of official tools in this review"
    },
    {
      "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, and do not omit a study merely because an outcome is unreported.",
      "review_level": "Reuse of preserved methodological principles/version from 1585 and actual original-byte copies of 5 HTML files; not new reading of methodological full texts or application of official tools in this review"
    },
    {
      "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, and review randomization, deviations, missingness, measurement, and selective reporting.",
      "review_level": "Reuse of preserved methodological principles/version from 1585 and actual original-byte copies of 5 HTML files; not new reading of methodological full texts or application of official tools in this review"
    },
    {
      "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": "Reuse of preserved methodological principles/version from 1585 and actual original-byte copies of 5 HTML files; not new reading of methodological full texts or application of official tools in this review"
    },
    {
      "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": "A harm question may require designs, populations, and follow-up different from those for efficacy. Case reports do not establish incidence rates.",
      "review_level": "Reuse of preserved methodological principles/version from 1585 and actual original-byte copies of 5 HTML files; not new reading of methodological full texts or application of official tools in this review"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some related material/bibliographic/historical information exists, but gaps remain in direct comparisons, products/denominators/plans, and access/harms",
    "Unverified": "The selected direct result or necessary material could not be verified within the preserved scope; this does not mean no effect or 0 studies",
    "Review incomplete": "Original-material comparison/search was not performed within the permitted scope",
    "Not reported": "A scope-limited status meaning that the item was not stated in the specific material/section read",
    "Inaccessible": "Used only for material for which access was actually attempted and failed. Not assigned to clinical material in this review",
    "Insufficient evidence meeting the conditions": "Used only when evidence is insufficient to answer a condition after relevant studies within the defined scope have been reviewed. Not applied comprehensively in this review",
    "Not applicable": "Extensions to optimal dose, persistence, all populations/clinical events are not imposed as additional requirements for the original FSS question; this does not substitute for other unverified matters",
    "Conflicting information": "When materials that are difficult to reconcile for the same question, time point, and analysis have been compared. Not assigned merely because a review reports different numerical values",
    "Met": "Verification of the stated preservation, boundaries/attribution, and linkage conditions; not direct FSS efficacy, original full-text reading, or safety certification"
  },
  "schema_version": "chamgap-public-criteria-1.0",
  "condition_origin": "Chamgap’s own application conditions",
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Independent claim",
      "question": "Which fatigue, intervention, and FSS comparison?",
      "needed": "Adults with nonspecific persistent fatigue, oral B5 as the sole active ingredient, comparator on the same background treatment, and between-group FSS results",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid combining all vitality claims for the ingredient or fatigue in different diseases into a single question.",
      "application_exception": "ME/CFS, lupus, correction of confirmed deficiency, treatment-related fatigue, and multicomponent products are separate.",
      "criterion": "Link the current original effect wording and inclusion/exclusion questions to exact locations.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare differences in population, intervention, and endpoint between the existing question and candidate results for each material."
    },
    {
      "item_id": "N02",
      "question_type": "Population criteria",
      "question": "How was the population with unexplained persistent fatigue defined?",
      "needed": "Diagnosis, exclusion tests, age, underlying diseases, and selection criteria",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid transferring CFS or lupus data merely because the same word, fatigue, is used.",
      "application_exception": "Do not fill an unverified value with an assertion that there was no underlying disease.",
      "criterion": "Distinguish actual diagnostic/exclusion criteria in the directly eligible population from what remains unverified.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Obtain recruitment and diagnostic tables for the target population and compare applicability boundaries with groups with other causes."
    },
    {
      "item_id": "N03",
      "question_type": "Persistence criteria",
      "question": "Are fatigue duration and baseline severity known?",
      "needed": "Fatigue-duration threshold, baseline FSS, and distribution by severity",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid using the label persistent fatigue as verified duration or severity values.",
      "application_exception": "Do not transfer disease diagnostic criteria or baseline scores from another trial.",
      "criterion": "Indicate whether actual duration and the baseline scale were verified in an eligible monotherapy trial.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Link recruitment criteria and baseline tables to time points/scale versions to review eligibility."
    },
    {
      "item_id": "N04",
      "question_type": "Intervention identity",
      "question": "Were B5 monotherapy and other molecules or multicomponent products distinguished?",
      "needed": "Documentation of pantothenic acid, the exact salt, other active ingredients, and route",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid converting effects of pantethine or multiple ingredients into effects of B5 alone.",
      "application_exception": "Verify the salt identity of calcium pantothenate separately and do not import a conversion from another product.",
      "criterion": "Link differences in chemical form, combination, and route in the original text with limits on direct attribution.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare manufacturing-composition and chemical-form documents for each result to verify sole-active-ingredient status."
    },
    {
      "item_id": "N05",
      "question_type": "Product specifications",
      "question": "Are the origin, quality, and formulation of an eligible single-active-ingredient product known?",
      "needed": "Exact salt, origin, purity, batch, brand, release type, and excipients",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid substituting specifications of a multicomponent product with a different brand for monotherapy specifications.",
      "application_exception": "Specifying a single-active-ingredient oral product in the question differs from actual product specifications.",
      "criterion": "Preserve verified values for a directly eligible formulation and unresolved fields separately.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Verify formulation specifications, active-ingredient analyses, and batch records for the eligible comparison together with the results."
    },
    {
      "item_id": "N06",
      "question_type": "Dose and frequency",
      "question": "What are the directly eligible B5 dose and actual total exposure?",
      "needed": "Single-active-ingredient product dose, frequency, salt mass, dietary/concurrent supplementation, and actual intake",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid using the high dose in a lupus combination regimen as a fatigue-treatment dose.",
      "application_exception": "Perform no new conversion of calcium pantothenate mass, and do not turn nutritional reference values into treatment doses.",
      "criterion": "Distinguish unverified eligible dose/frequency from related-study and nutritional values.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; details of dose, duration, and effect modification are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Obtain administration, adherence, and dietary-exposure records from a comparative monotherapy trial to assess actual exposure."
    },
    {
      "item_id": "N07",
      "question_type": "Duration and time points",
      "question": "Have eligible treatment duration and FSS assessment time points been specified?",
      "needed": "Treatment duration, planned endpoint time points, follow-up, and discontinuation time points",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid transferring the 28-day, 56-day, and follow-up visits for a multicomponent product to a monotherapy duration.",
      "application_exception": "Do not arbitrarily specify a universal minimum duration.",
      "criterion": "Separate unverified eligible treatment duration/assessment time points from the time points in related reports.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.1–3.2.4; details of dose, duration, and effect modification are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Collect plans, actual administration duration, and each follow-up result separately and compare them with prespecified endpoints."
    },
    {
      "item_id": "N08",
      "question_type": "Comparator and background treatment",
      "question": "Are placebo or usual care and common treatment actually the same?",
      "needed": "Placebo composition, background treatment, rescue medication, and arm-specific changes",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid attributing effects of different background treatments to an additional B5 effect.",
      "application_exception": "Do not require all changes in both arms to be identical; record the actual effect of interest.",
      "criterion": "Distinguish the comparator specified in the question from actual common treatment/changes in an eligible trial.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests 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": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare arm-specific prescription, placebo, rescue-treatment, and change records for the eligible comparison against the analysis plan."
    },
    {
      "item_id": "N09",
      "question_type": "Baseline nutrition",
      "question": "Can diet, deficiency, and concurrent supplementation be distinguished?",
      "needed": "Baseline nutrition, B5-deficiency testing, diet, and concurrent active ingredients",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid mixing correction of deficiency with additional supplementation for nonspecific fatigue.",
      "application_exception": "Do not establish that participants are nondeficient if deficiency information is unavailable.",
      "criterion": "Link differences between the selected population's baseline status and disease/deficiency cases.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation to tests are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Obtain baseline nutrition, deficiency measurements, and concurrent-supplementation information by arm to review applicability."
    },
    {
      "item_id": "N10",
      "question_type": "FSS version",
      "question": "Have the actual FSS version, range, and scoring method been verified?",
      "needed": "Actual FSS version, items/range, aggregation, direction, and measurement procedures",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid mistaking the selection of FSS as the prioritized scale for verification of its actual use.",
      "application_exception": "Do not convert CIS, Chalder, vitality, or mood into FSS.",
      "criterion": "Distinguish the scale prioritized in the question from the actual scale in an eligible monotherapy trial.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare the actual scale version and scoring/collection procedures against results tables and blinding information."
    },
    {
      "item_id": "N11",
      "question_type": "Endpoint attribution",
      "question": "Are FSS, CIS, Chalder, and mechanisms the same outcome?",
      "needed": "Scale, primary/secondary endpoint, time point, population, and intervention for each material",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid using different symptom scales or physiological markers as the same direct effect.",
      "application_exception": "Do not delete results on other scales; retain them under their respective questions.",
      "criterion": "Attribute each result's population, scale, and time point to its original location.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.4; internally specified boundary on extensions",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare the original definitions of different scales and planned endpoints, and do not merge them into a common effect."
    },
    {
      "item_id": "N12",
      "question_type": "Effect of interest",
      "question": "Were between-group differences in change distinguished from endpoint differences and within-group differences?",
      "needed": "Baseline, change, and endpoint values, definition of between-group comparison, and adjustment/analysis methods",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning within-group improvement into an effect superior to placebo.",
      "application_exception": "Do not fill in an analysis not specified in the original text as ITT or an adjusted effect.",
      "criterion": "Indicate the between-group/within-group and change/endpoint definitions of the actual selected results and the gaps.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare eligible results tables against the analysis plan to verify estimates and denominators for the effect of interest."
    },
    {
      "item_id": "N13",
      "question_type": "Effect estimate and interval",
      "question": "Are the directly relevant FSS effect, CI, and P value known?",
      "needed": "Eligible between-group effect, uncertainty interval, P value, and units",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid filling in an effect based on significance or the number of related studies.",
      "application_exception": "Do not turn an unverified result into an effect of 0, nonsignificance, or equivalence.",
      "criterion": "Distinguish empty values in primary_effect from the direction of related reports.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Obtain estimates, intervals, variances, and denominators from the original results tables and attribute them to the reported effect definition."
    },
    {
      "item_id": "N14",
      "question_type": "Directly relevant analysis denominators",
      "question": "How many participants were allocated, analyzed, and completed, respectively?",
      "needed": "Arm-specific allocation, analysis, completion, and missing-data/dropout handling in an eligible monotherapy trial",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid using another trial's total sample size as the directly relevant FSS analysis denominator.",
      "application_exception": "Do not transfer Ullah 58 or Brouwers 53/48 as monotherapy denominators.",
      "criterion": "Distinguish eligible outcome-specific denominators from what remains unverified.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare participant flow, reasons for missing data, and outcome-specific analysis tables to verify denominators."
    },
    {
      "item_id": "N15",
      "question_type": "Allocation and blinding",
      "question": "Are allocation, concealment, and assessment procedures in the direct comparison known?",
      "needed": "Actual design, allocation/concealment, baseline balance, and assessor/participant blinding",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid using a related RCT label as a bias assessment of an eligible monotherapy trial.",
      "application_exception": "Do not arbitrarily mark crossover or cluster designs as not applicable when the design is unverified.",
      "criterion": "Link actual design/measurement information for the direct results with the missing material.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.1; detailed population conditions are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Review the scope of verification of allocation and outcome measurement using eligible methods, registrations, and baseline/assessment materials."
    },
    {
      "item_id": "N16",
      "question_type": "Analysis and withdrawals",
      "question": "Were the effects of ITT/PP, adherence, rescue treatment, and missing data verified?",
      "needed": "Effect of interest, analysis population, adherence, arm-specific changes, and missing-data handling",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid mixing the effect of assignment with effects among adherent participants or before-and-after results among completers.",
      "application_exception": "Do not arbitrarily assume ITT if the analysis method is unavailable.",
      "criterion": "Indicate the directly eligible analysis and why verification is not possible.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Match the analysis plan, adherence, and participant flow with results tables to distinguish the actual effect of interest."
    },
    {
      "item_id": "N17",
      "question_type": "Importance and precision",
      "question": "What magnitude of fatigue difference does the interval allow?",
      "needed": "Direct effect/CI, endpoint-specific variance, and the basis for an MCID",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid declaring sufficiency based only on sample size, statistical significance, or the number of reports.",
      "application_exception": "Do not arbitrarily adopt an MCID, minimum sample size, or common duration.",
      "criterion": "Explain the reported interval and importance criterion, or why interpretation is not possible.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are this project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Obtain the basis for an important difference appropriate to the endpoint version and the actual result interval separately, and compare them."
    },
    {
      "item_id": "N18",
      "question_type": "Positive combination-product results",
      "question": "What produced the FSS improvement in Ullah?",
      "needed": "Product composition, endpoints, time points, and arm-specific results in the 58-participant trial",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to limit attribution to a single ingredient while preserving favorable related results.",
      "application_exception": "Do not isolate a contribution from B5 solely because it was included.",
      "criterion": "Link the positive results with the actual combination product and denominator limitations.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for tests are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are this project's own design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is this project's own design; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Review the combination trial's original tables, composition, and whether individual factors were compared to verify whether an independent B5 contribution can be estimated."
    },
    {
      "item_id": "N19",
      "question_type": "Reports of the same trial",
      "question": "Are the Ullah full text, abstract, and preliminary evaluation independent replications?",
      "needed": "S201/S202/S203 report identities, DOI/PMID, and cohort linkage",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid counting reports as unique trials.",
      "application_exception": "Do not establish cohort linkage for the preliminary evaluation solely from similar names.",
      "criterion": "Distinguish the explicit identity of reports of the same trial from the unresolved relationship with the preliminary evaluation.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Trace the registration, recruitment, product, and participant relationships for each report to check for overlap."
    },
    {
      "item_id": "N20",
      "question_type": "Combination-product results with no detected difference",
      "question": "Does nonsignificance in Brouwers mean that B5 alone is ineffective?",
      "needed": "CIS, design, between-group results, and original tables for the CFS combination product",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to preserve unfavorable related findings as well and avoid converting them into an effect of 0 for a different question.",
      "application_exception": "Do not turn nonsignificance into equivalence or ineffectiveness for all fatigue.",
      "criterion": "Link the differences in population, combination product, and CIS with the scope of the nonsignificant findings.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is this project's own design; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Check the original CIS results and analysis, composition, and population materials to limit direct attribution to FSS."
    },
    {
      "item_id": "N21",
      "question_type": "CFS denominators",
      "question": "What denominators do 53 allocated and 48 completed represent?",
      "needed": "Brouwers arm-specific allocation, completion, outcome-specific analyses, and handling of dropouts",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid merging allocation/completion counts from a related trial into the same analysis denominator.",
      "application_exception": "Do not calculate new dropout counts or arm-specific rates from the difference.",
      "criterion": "Attribute the original 53 (27/26) allocated and 48 completed to the corresponding combination-product trial.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are this project's own design; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare participant flow with the CIS analysis population to verify arm-specific missingness and outcome denominators."
    },
    {
      "item_id": "N22",
      "question_type": "Lupus narrative",
      "question": "Is the improvement in 12 people with lupus a single-ingredient comparison?",
      "needed": "Case populations, concomitant prescriptions, comparator, and validated fatigue scale",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning an uncontrolled multiple-vitamin narrative into a between-group result for a single ingredient.",
      "application_exception": "Do not convert calcium-salt mass or transfer a disease-specific sample to the target population.",
      "criterion": "Link the original 12 participants, 10 g/day, and concomitant vitamins with the reasons for direct exclusion.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for tests are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are this project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Check prescriptions, populations, fatigue collection, and the presence of a comparator for each case to examine the limits of causality/direct applicability."
    },
    {
      "item_id": "N23",
      "question_type": "Case overlap",
      "question": "Do the cases in the 2004 and 2007 lupus reports overlap?",
      "needed": "Populations, recruitment, case numbers, periods, and linkage in the two reports",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid counting repeat reports of the same cases as independent replications and additional participants.",
      "application_exception": "Do not establish that cases differ solely from publication years.",
      "criterion": "Preserve the original uncertainty about overlap and the principle of not summing the samples.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M04 §4.6.1–4.6.2; adaptation for harm data is this project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare case tables and periods in the two original reports and record whether they are the same, different, or unresolved."
    },
    {
      "item_id": "N24",
      "question_type": "Repeated citation in reviews",
      "question": "Are the rheumatology reviews separate direct trials?",
      "needed": "Original reports included in S208/S209, linkage to Leung, and overlap",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid double-counting reviews and their included cases as unique trials.",
      "application_exception": "An indication of historical full-text access to a review is not direct reading in this review.",
      "criterion": "Distinguish the bibliographic records and historical locations of the two reviews from direct material from original trials.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare family relationships among included-study tables, original reports, and related reviews to link endpoints and repeated citations."
    },
    {
      "item_id": "N25",
      "question_type": "A different registered endpoint",
      "question": "Is Chalder in BEMS a direct FSS result?",
      "needed": "ACTRN registration, healthy women aged 50~75, multicomponent composition, and endpoint hierarchy/results",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid elevating the existence of a registration to a target single-ingredient FSS result.",
      "application_exception": "Distinguish the planned registered sample from actual allocated/analyzed counts.",
      "criterion": "Link the population, combination intervention, secondary endpoint, and unverified actual results.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for tests are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are this project's own design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Link the registration and results report by exact identity to compare the planned Chalder endpoint with the actual results."
    },
    {
      "item_id": "N26",
      "question_type": "Registry-access limitations",
      "question": "Does a CTG shell mean that results are absent?",
      "needed": "Actual text, interventions/endpoints, and results of NCT02804828 and NCT07271316",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning access failures or shell pages into negative trials or 0 studies worldwide.",
      "application_exception": "No current access was attempted, and historical shells are not treated as failures in this review.",
      "criterion": "Distinguish historical search leads and shells from unverified plans/results.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user's scope and this project's own design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "In an authorized subsequent update, read the registration text and results and compare the exact products and endpoints indicated by the leads."
    },
    {
      "item_id": "N27",
      "question_type": "Nonhuman mechanisms",
      "question": "Do mouse fatigue and CoA functions constitute an FSS effect in adults?",
      "needed": "Species, experimental intervention, physiological/behavioral endpoints, and limits of human applicability",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid substituting mechanisms or animal responses for direct human treatment effects.",
      "application_exception": "Traditional uses or metabolic functions are not eligible between-group effect estimates.",
      "criterion": "Identify nonhuman/mechanistic materials at a separate level, with their original bibliographic locations.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M03 §3.2.4; this project's own boundary on extensions",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "State the differences between animal/mechanistic observations and the human clinical question, and do not combine them with direct results."
    },
    {
      "item_id": "N28",
      "question_type": "Deficiency case reports",
      "question": "Can B5 deficiency case reports be used for the same fatigue treatment?",
      "needed": "Deficiency diagnosis, correction, population, and assessment endpoints",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to distinguish correction of a specific deficiency from additional supplementation for nonspecific persistent fatigue.",
      "application_exception": "Do not reclassify the material as a comparative FSS trial in adults when original details are absent.",
      "criterion": "Indicate the bibliographic/access level of deficiency cases and the boundaries for direct exclusion.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user's scope and this project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Check the actual populations, endpoints, and exposures in deficiency/correction cases to examine how they differ from the selected question."
    },
    {
      "item_id": "N29",
      "question_type": "Exercise endpoints",
      "question": "Does the older sports-vitamin material answer the FSS question?",
      "needed": "Product composition, populations, exercise/fatigue endpoints, and actual analyses",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid substituting exercise performance or vitality wording for FSS in persistent fatigue.",
      "application_exception": "Do not establish single-ingredient intervention/scale eligibility from bibliographic records or search abstracts.",
      "criterion": "Link the verified level of material with the reasons for not attributing it directly.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for tests are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; M03 §3.2.4; this project's own boundary on extensions",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare the composition, population, and endpoint tables of the original sports trial to record its differences from the direct question."
    },
    {
      "item_id": "N30",
      "question_type": "Association and metabolomics",
      "question": "Do ME/CFS metabolomic data represent a single-ingredient treatment effect?",
      "needed": "Direction of exposure, disease, metabolomic findings, and whether a direct intervention exists",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid reversing associations or surrogate markers into an effect of administering the ingredient.",
      "application_exception": "Do not extrapolate metabolomic differences to doses or individual treatment responses.",
      "criterion": "Indicate the disease/endpoint level of the search leads and the lack of direct attribution.",
      "basis": "M03 §3.2.1; detailed population conditions are this project's own design; M03 §3.2.2–3.2.3; reverse-direction labeling and adaptations for tests are this project's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are this project's own design; data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; M03 §3.2.4; this project's own boundary on extensions",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Check the direction and comparative design of observational metabolomic data and separate them from the direct FSS intervention question."
    },
    {
      "item_id": "N31",
      "question_type": "Patent lead",
      "question": "Do patent examples constitute clinical comparative evidence?",
      "needed": "Populations, experiments, and independent clinical results in the US5304574A examples",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid confusing the existence of a patent with eligible trials or demonstrated efficacy.",
      "application_exception": "Do not label patent rights/cases as independent replications of efficacy.",
      "criterion": "Link the verified patent search-index level to its original location.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; Chamgap's own conditions for independence and attribution. The official methods sections used in this pilot do not guarantee all of these detailed items; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare the relationship between the patent lead and actual clinical reports, including whether they concern the same cases, and verify direct evidence separately."
    },
    {
      "item_id": "N32",
      "question_type": "Actual reading",
      "question": "Were preserved archived summaries distinguished from historical full-text access?",
      "needed": "Identity, current locations/values/SHA read, and historical access/dates for each material",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning a URL or historical access into original-paper reading in this review.",
      "application_exception": "Historical CAPTCHAs, shells, and unacquired material are not current access failures, and access dates are not inferred.",
      "criterion": "Indicate the summaries actually read in the current review separately from external materials not attempted/not read, and connect the links.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; separation of access and reading and the hyperlink contract are this project's own design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user's scope and this project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "When material acquisition is separately authorized, record access levels, dates, original bytes, and locations read for each report."
    },
    {
      "item_id": "N33",
      "question_type": "Absence gate",
      "question": "Does no_human_study mean that all human studies are absent?",
      "needed": "Original flags, scope, directly eligible/related human-study existence, and search limitations",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid reading a code flag as 0 studies worldwide or no effect.",
      "application_exception": "Do not alter the original true/false/empty values to make them identical.",
      "criterion": "Preserve the original flags together with their semantic limitations and the existence of related human studies.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is this project's own design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user's scope and this project's own design; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "When updating, review the link between direct eligibility, search scope, and code meaning, and distinguish raw values from the current explanation."
    },
    {
      "item_id": "N34",
      "question_type": "Preservation of the original judgment",
      "question": "What do ?, empty values, and the subsequent 5 axes mean?",
      "needed": "Original grade/score, application of each axis, gate rationale, and historical calculation references",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid elevating new verification statuses into efficacy grades or scores.",
      "application_exception": "Do not merge document quality B with efficacy ?, or rerun the original calculator.",
      "criterion": "Preserve the applied/unscored meaning of the original B/P/5 null axes, ?, and empty score.",
      "basis": "M04 §4.5, §4.6.3; limitations of the current material conversion follow the user's scope and this project's own design; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "In a future, separately authorized update of the criteria, compare and distinguish the original inputs, rules, actual calculations, and valid judgments."
    },
    {
      "item_id": "N35",
      "question_type": "Conflicts of interest",
      "question": "What is known about products, company-affiliated authors, and funding?",
      "needed": "Product provision, manufacture, company affiliations, research funding, patents, and disclosed COI",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning partial company information or unverified information into independent funding/independent replication.",
      "application_exception": "Do not delete results because conflicts of interest exist or treat their absence as absence of bias.",
      "criterion": "Distinguish the reported Esserre, Numico, and Swisse information from what remains unverified.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methods sections used in this pilot do not guarantee all of these detailed items; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare original disclosures, product supply, and funding/employment information by study family, and limit the interpretation of independence."
    },
    {
      "item_id": "N36",
      "question_type": "Registration and selective reporting",
      "question": "Was the target FSS outcome prespecified?",
      "needed": "Eligible single-active-ingredient trial registration, protocol, SAP, reasons for changes, and all results",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid turning the failure to acquire direct plans into confirmation of nonregistration or selective reporting.",
      "application_exception": "The related BEMS registration is a plan for a different population, product, and scale.",
      "criterion": "Link the plans compared and the scope of direct material not compared to their locations.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of the current material conversion follow the user's scope and the project's own design",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Compare registration/SAP with the actual FSS version, time points, and analyses, and record the scope of changes and nonreporting."
    },
    {
      "item_id": "N37",
      "question_type": "Extension questions",
      "question": "Are optimal dose, persistence, and efficacy in special populations also required?",
      "needed": "Separate direct dose comparisons, follow-up after discontinuation, and prespecified subgroups/interactions",
      "role": "Supplementary (required for separate extension questions)",
      "role_reason": "Needed to avoid extending the narrow FSS question to all long-term and optimal-dose claims.",
      "application_exception": "The actual duration relevant to the assessed claim must be verified, but optimal-dose/all-subgroup trials are not imposed as additional requirements.",
      "criterion": "Record separately the nonapplicability boundary for extensions of efficacy beyond the direct question and what remains unverified.",
      "basis": "M03 §3.2.1–3.2.4; details of dose, persistence, and effect modification are internally designed; M03 §3.2.4; internally specified boundary on extensions; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "If an extension question is separately requested, review direct dose/follow-up/interaction designs against their plans and results."
    },
    {
      "item_id": "N38",
      "question_type": "Level of harm evidence",
      "question": "How much is known about diarrhea and discontinuations with the same single-active-ingredient exposure?",
      "needed": "Event definitions, collection, exposure, time, denominators, arm-specific discontinuations, and concomitant use/causes",
      "role": "Supplementary (harm and safety boundaries for the same exposure)",
      "role_reason": "Needed to avoid converting general safety commentary into incidence rates in the target single-active-ingredient trial or overall safety.",
      "application_exception": "Do not turn unverified efficacy into safety or copy cautions for combination products/pantethine.",
      "criterion": "Distinguish the NIH high-dose GI warning from gaps in denominators/methods for direct target harms.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed; M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; Chamgap's own interpretive boundary. The principles of M19 are referenced; this is not an application of a formal causality tool",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Separately review systematic harm/discontinuation, concomitant-use, and follow-up data for the same single-active-ingredient product and population."
    },
    {
      "item_id": "N39",
      "question_type": "Long-term use and vulnerable populations",
      "question": "Has safety been verified for long-term high-dose use, special populations, and concomitant use?",
      "needed": "Data on long-term exposure, rare events, pregnancy/lactation/children, liver/kidney disease, and concomitant use",
      "role": "Supplementary (extension to long-term/vulnerable-population safety)",
      "role_reason": "Needed to avoid using limited general descriptions as proof of safety for all populations/combinations.",
      "application_exception": "Do not establish that unverified interactions are absent.",
      "criterion": "Preserve the safety limitations for the selected fatigue purpose and the original Caution label.",
      "basis": "M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretive boundary. The principles of M19 are referenced; this is not an application of a formal causality tool",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "Review long-term/vulnerable-population and concomitant-use studies with matching exposure and baseline risk in relation to their separate designs and actual collection methods."
    },
    {
      "item_id": "N40",
      "question_type": "Review and updates",
      "question": "What can change, as of which date and within which material scope?",
      "needed": "Original review date, scope actually read in the current review, new evidence/corrections, and preservation of versions/original text",
      "role": "Required (selected B5 monotherapy comparison for FSS in nonspecific persistent fatigue)",
      "role_reason": "Needed to avoid overstating the current table conversion as a current comprehensive search, publication, or official certification.",
      "application_exception": "The original first_published_at is an editorial reference date, not proof of actual server deployment.",
      "criterion": "Distinguish the original date and self-review, what has not been newly performed, and the conditions for updates/the same ID.",
      "basis": "M04 §4.5, §4.6.3; the limits of the current material conversion follow the user's scope and the project's own design; data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are internally designed",
      "condition_origin": "Known development conditions designed after reading all currently retained 3101 material; not blinded, clinically preregistered, or independently certified",
      "proposed_research": "In a separately authorized update event, preserve the identity of new material, the full original text, and before/after values, and review linked conditions again."
    }
  ],
  "language": "en",
  "translation_date": "2026-11-02"
}