{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3101-main", "verdict_number": "3101", "title": "Oral pantothenic acid (vitamin B5) as the sole active ingredient × Reduction of FSS fatigue severity in adults with unexplained/nonspecific persistent fatigue", "view_version": "1.0", "view_created_date": "2026-11-02", "criteria_version": "NGM-v3101-SOLE-B5-NONSPECIFIC-PERSISTENT-FATIGUE-FSS-1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-15", "review_scope": { "materials_read": "Archived Korean and English manuscripts and case-specific conditions and application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "No external clinical abstracts, full texts, registrations, or analysis plans were newly read. Historical access records are distinguished from the current reading of archived summaries. The original judgment, numerical values, and unverified matters were preserved, and no new search, calculation, or regrading was performed.", "date_meaning": "This is the date the archived material was checked, not the date of the latest clinical literature search." }, "claim_context": { "population": "Adults with unexplained/nonspecific persistent fatigue; separate from specific diseases and correction of deficiency", "intervention": "Pantothenic acid (vitamin B5) as the sole active ingredient; exact salt to be verified separately · Oral formulation with a single active ingredient; salt, tablet/capsule, and release type unverified", "dose": "Unverified — eligible monotherapy dose and frequency not verified", "comparator": "Placebo or usual care on the same background treatment; actual composition and concomitant treatment unverified", "endpoint": "Priority given to the between-group difference in change in FSS; endpoint difference separate; version, scoring method, and time points in an eligible trial unverified", "duration": "Unverified — eligible monotherapy treatment duration and assessment time points not verified", "excluded_extensions": "Specific diseases/correction of deficiency, B-complex products/pomegranate/multivitamins, other molecules/routes, CIS/Chalder/exercise/metabolomics, diarrhea harms/optimal dose/persistence/all populations, and clinical events are separate. /subclaims=[]" }, "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.", "current_reports": [ "S201", "S202", "S204", "S205", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The selected question is whether oral treatment with pantothenic acid as the sole active ingredient lowers FSS more than placebo or usual care on the same background treatment in adults with unexplained/nonspecific persistent fatigue. subclaims is an empty list.", "condition_status": "Met", "status_reason": "This verifies the identity of the question, not an effect or the absence of all human studies.", "missingness": "This verifies the identity of the question, not an effect or the absence of all human studies.", "uncertainty": "This verifies the identity of the question, not an effect or the absence of all human studies.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Adults with nonspecific persistent fatigue, oral B5 as the sole active ingredient, comparator on the same background treatment, and between-group FSS results" }, { "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.", "current_reports": [ "S201", "S205", "S207", "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The population was fixed to adults with unexplained/nonspecific persistent fatigue, but diagnosis, baseline nutrition/deficiency, and exclusion criteria in eligible monotherapy trials were not verified.", "condition_status": "Unverified", "status_reason": "The population specified in the question does not substitute for actual recruitment criteria in an eligible study.", "missingness": "The population specified in the question does not substitute for actual recruitment criteria in an eligible study.", "uncertainty": "The population specified in the question does not substitute for actual recruitment criteria in an eligible study.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Diagnosis, exclusion tests, age, underlying diseases, and selection criteria" }, { "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.", "current_reports": [ "S201", "S202" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The fatigue-duration criterion and baseline FSS in a directly relevant monotherapy trial are unverified within the preserved scope.", "condition_status": "Unverified", "status_reason": "Do not fill in the duration for the selected question solely from the prolonged fatigue label in a related product trial.", "missingness": "Do not fill in the duration for the selected question solely from the prolonged fatigue label in a related product trial.", "uncertainty": "Do not fill in the duration for the selected question solely from the prolonged fatigue label in a related product trial.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Fatigue-duration threshold, baseline FSS, and distribution by severity" }, { "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.", "current_reports": [ "S06", "S201", "S205", "S207", "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The question concerns oral B5 as the sole active ingredient. Pantethine, pantetheine, dexpanthenol/panthenol, B-complex products, multivitamins, and multicomponent energy products were distinguished from the direct intervention. The exact eligible salt is unverified.", "condition_status": "Met", "status_reason": "This verifies the distinction between boundaries; it does not mean that a specific single-active-ingredient product was acquired.", "missingness": "This verifies the distinction between boundaries; it does not mean that a specific single-active-ingredient product was acquired.", "uncertainty": "This verifies the distinction between boundaries; it does not mean that a specific single-active-ingredient product was acquired.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Documentation of pantothenic acid, the exact salt, other active ingredients, and route" }, { "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.", "current_reports": [ "S201", "S202", "S203", "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Origin, salt, brand, purity, batch, formulation, and release type are unverified in eligible monotherapy trials.", "condition_status": "Unverified", "status_reason": "Esserre or Swisse brand information belongs to the respective multicomponent product.", "missingness": "Esserre or Swisse brand information belongs to the respective multicomponent product.", "uncertainty": "Esserre or Swisse brand information belongs to the respective multicomponent product.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Exact salt, origin, purity, batch, brand, release type, and excipients" }, { "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.", "current_reports": [ "S06", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The eligible monotherapy dose and frequency are unverified. Calcium pantothenate 10 g/day in the lupus cases and NIH nutritional reference values do not fill in a directly relevant fatigue-treatment dose.", "condition_status": "Unverified", "status_reason": "Nominal or actual amounts and salt conversions were not arbitrarily generated.", "missingness": "Nominal or actual amounts and salt conversions were not arbitrarily generated.", "uncertainty": "Nominal or actual amounts and salt conversions were not arbitrarily generated.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Single-active-ingredient product dose, frequency, salt mass, dietary/concurrent supplementation, and actual intake" }, { "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.", "current_reports": [ "S201", "S202" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Eligible monotherapy treatment duration and assessment time points are unverified. Assessments at 28 days and 56 days and follow-up visits for Ullah's multicomponent product were preserved as distinct.", "condition_status": "Unverified", "status_reason": "A different formulation's schedule does not verify duration for the selected question.", "missingness": "A different formulation's schedule does not verify duration for the selected question.", "uncertainty": "A different formulation's schedule does not verify duration for the selected question.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Treatment duration, planned endpoint time points, follow-up, and discontinuation time points" }, { "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.", "current_reports": [ "S201", "S205", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Placebo or usual care on identical background treatment is the planned comparison. Placebo composition, common treatment, and rescue medication in eligible monotherapy trials are unverified.", "condition_status": "Unverified", "status_reason": "The presence of a control arm in a multicomponent trial alone does not meet the monotherapy comparison conditions.", "missingness": "The presence of a control arm in a multicomponent trial alone does not meet the monotherapy comparison conditions.", "uncertainty": "The presence of a control arm in a multicomponent trial alone does not meet the monotherapy comparison conditions.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Placebo composition, background treatment, rescue medication, and arm-specific changes" }, { "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.", "current_reports": [ "S211", "S06" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Baseline nutrition and deficiency status in eligible monotherapy trials are unverified. Deficiency case reports and the nonspecific-fatigue question are separate.", "condition_status": "Unverified", "status_reason": "Do not fill in baseline information with mechanisms or blood markers.", "missingness": "Do not fill in baseline information with mechanisms or blood markers.", "uncertainty": "Do not fill in baseline information with mechanisms or blood markers.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Baseline nutrition, B5-deficiency testing, diet, and concurrent active ingredients" }, { "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.", "current_reports": [ "S201", "S202", "S205", "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "FSS is the prioritized scale for this question. Its actual version, range, and scoring method in an eligible monotherapy trial are unverified.", "condition_status": "Unverified", "status_reason": "An FSS label does not mean that all measurement conditions have been verified.", "missingness": "An FSS label does not mean that all measurement conditions have been verified.", "uncertainty": "An FSS label does not mean that all measurement conditions have been verified.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Actual FSS version, items/range, aggregation, direction, and measurement procedures" }, { "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.", "current_reports": [ "S201", "S202", "S204", "S205", "S210", "S213", "S216" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "FSS for Ullah's multicomponent product, CIS for the CFS multicomponent product, the secondary Chalder endpoint in the healthy-women registration, and animal/metabolic and exercise markers were distinguished.", "condition_status": "Met", "status_reason": "Improvement in related symptoms or mechanistic observations does not substitute for the FSS effect of B5 alone.", "missingness": "Improvement in related symptoms or mechanistic observations does not substitute for the FSS effect of B5 alone.", "uncertainty": "Improvement in related symptoms or mechanistic observations does not substitute for the FSS effect of B5 alone.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Scale, primary/secondary endpoint, time point, population, and intervention for each material" }, { "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.", "current_reports": [ "S201", "S205", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The question was fixed to prioritize the between-group difference in change in FSS, with endpoint differences separate, but monotherapy baseline, change, and endpoint values and the actual analysis are unverified.", "condition_status": "Unverified", "status_reason": "Do not estimate a between-group monotherapy effect from improvement with a multicomponent product or subjective lupus narratives.", "missingness": "Do not estimate a between-group monotherapy effect from improvement with a multicomponent product or subjective lupus narratives.", "uncertainty": "Do not estimate a between-group monotherapy effect from improvement with a multicomponent product or subjective lupus narratives.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Baseline, change, and endpoint values, definition of between-group comparison, and adjustment/analysis methods" }, { "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.", "current_reports": [ "S201", "S205", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The primary_effect.mean_difference, confidence_interval, p_value, and analysis sample-size records are empty/not_verified.", "condition_status": "Unverified", "status_reason": "No graphs, correlations, variances, or effect estimates were newly calculated or reconstructed.", "missingness": "No graphs, correlations, variances, or effect estimates were newly calculated or reconstructed.", "uncertainty": "No graphs, correlations, variances, or effect estimates were newly calculated or reconstructed.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Eligible between-group effect, uncertainty interval, P value, and units" }, { "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.", "current_reports": [ "S201", "S202", "S204", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Arm-specific allocation, FSS analysis, and completion denominators in directly eligible monotherapy trials are unverified. Known denominators from related trials remain attributed only to each respective study.", "condition_status": "Unverified", "status_reason": "No effect or incidence rate was calculated without a denominator.", "missingness": "No effect or incidence rate was calculated without a denominator.", "uncertainty": "No effect or incidence rate was calculated without a denominator.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Arm-specific allocation, analysis, completion, and missing-data/dropout handling in an eligible monotherapy trial" }, { "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.", "current_reports": [ "S201", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The preserved materials include related multicomponent-product RCTs, but allocation, concealment, and blinding in a direct monotherapy FSS comparison are unverified.", "condition_status": "Unverified", "status_reason": "Do not label this as formal execution of RoB 2 or absence of bias.", "missingness": "Do not label this as formal execution of RoB 2 or absence of bias.", "uncertainty": "Do not label this as formal execution of RoB 2 or absence of bias.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Actual design, allocation/concealment, baseline balance, and assessor/participant blinding" }, { "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.", "current_reports": [ "S201", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Adherence, arm-specific analyses, and handling of missing data/rescue treatment in eligible monotherapy trials are unverified.", "condition_status": "Unverified", "status_reason": "The reporting of completers in a related multicomponent-product trial does not verify missing-data handling for monotherapy results.", "missingness": "The reporting of completers in a related multicomponent-product trial does not verify missing-data handling for monotherapy results.", "uncertainty": "The reporting of completers in a related multicomponent-product trial does not verify missing-data handling for monotherapy results.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Effect of interest, analysis population, adherence, arm-specific changes, and missing-data handling" }, { "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.", "current_reports": [ "S201", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The direct between-group FSS CI, variance, and MCID are unverified. The remaining precision axis is also an unscored empty value in the original material.", "condition_status": "Unverified", "status_reason": "Do not use an unverified interval as evidence excluding an important effect or establishing an effect of 0.", "missingness": "Do not use an unverified interval as evidence excluding an important effect or establishing an effect of 0.", "uncertainty": "Do not use an unverified interval as evidence excluding an important effect or establishing an effect of 0.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Direct effect/CI, endpoint-specific variance, and the basis for an MCID" }, { "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.", "current_reports": [ "S201", "S202" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Ullah 2023 allocated 58 participants, 29 per arm, to study a product containing pomegranate extract, B-complex vitamins, and vitamin C, and reported FSS improvement. Assessments at 28 days and 56 days were distinguished from follow-up. FSS analysis denominators, completion counts, and the contribution of B5 alone are unverified.", "condition_status": "Partly verified", "status_reason": "The positive combination-product results were neither deleted nor elevated to a direct single-ingredient effect.", "missingness": "The positive combination-product results were neither deleted nor elevated to a direct single-ingredient effect.", "uncertainty": "The positive combination-product results were neither deleted nor elevated to a direct single-ingredient effect.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Product composition, endpoints, time points, and arm-specific results in the 58-participant trial" }, { "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.", "current_reports": [ "S201", "S202", "S203" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S201 and S202 are the full text/abstract of the same Ullah RCT and have the same DOI and PMID. S203 is a citation concerning chemical characterization and preliminary evaluation, and the details of its original text are unverified.", "condition_status": "Partly verified", "status_reason": "S203 was not added as an independent single-ingredient FSS trial, and its exact cohort relationship was not established.", "missingness": "S203 was not added as an independent single-ingredient FSS trial, and its exact cohort relationship was not established.", "uncertainty": "S203 was not added as an independent single-ingredient FSS trial, and its exact cohort relationship was not established.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "S201/S202/S203 report identities, DOI/PMID, and cohort linkage" }, { "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.", "current_reports": [ "S204", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Brouwers 2002 is a trial of a polynutrient supplement in CFS patients and did not report a significant between-group difference in CIS fatigue or other outcomes. It is directly ineligible for the question of B5 alone and FSS.", "condition_status": "Partly verified", "status_reason": "The nonreporting wording in the original evidence.result and the explanation of nonsignificance in the main text are preserved at their respective locations, without converting them into an effect of 0 for the single ingredient.", "missingness": "The nonreporting wording in the original evidence.result and the explanation of nonsignificance in the main text are preserved at their respective locations, without converting them into an effect of 0 for the single ingredient.", "uncertainty": "The nonreporting wording in the original evidence.result and the explanation of nonsignificance in the main text are preserved at their respective locations, without converting them into an effect of 0 for the single ingredient.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "CIS, design, between-group results, and original tables for the CFS combination product" }, { "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.", "current_reports": [ "S204", "S205" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Brouwers allocated 53 participants (27/26), and 48 completed. These are denominators for the CFS combination product, not FSS analysis denominators for B5 alone.", "condition_status": "Partly verified", "status_reason": "No new arm-specific completion counts or direct FSS denominators were estimated beyond the preserved values.", "missingness": "No new arm-specific completion counts or direct FSS denominators were estimated beyond the preserved values.", "uncertainty": "No new arm-specific completion counts or direct FSS denominators were estimated beyond the preserved values.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Brouwers arm-specific allocation, completion, outcome-specific analyses, and handling of dropouts" }, { "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.", "current_reports": [ "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The 2007 lupus report is a case series in which 12 women received calcium pantothenate 10 g/day together with several vitamins and combination tablets. It describes subjective fatigue improvement; a concurrent comparator and validated between-group FSS results were not verified.", "condition_status": "Partly verified", "status_reason": "The disease, combined exposure, comparison, and scale all differ from the selected direct question.", "missingness": "The disease, combined exposure, comparison, and scale all differ from the selected direct question.", "uncertainty": "The disease, combined exposure, comparison, and scale all differ from the selected direct question.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Case populations, concomitant prescriptions, comparator, and validated fatigue scale" }, { "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.", "current_reports": [ "S206", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Whether the cases in the 2004 S206 and 2007 S207 lupus reports overlap is unclear. The preserved original text did not add the samples together.", "condition_status": "Partly verified", "status_reason": "Different journals, years, or URLs are not evidence of independent cases.", "missingness": "Different journals, years, or URLs are not evidence of independent cases.", "uncertainty": "Different journals, years, or URLs are not evidence of independent cases.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Populations, recruitment, case numbers, periods, and linkage in the two reports" }, { "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.", "current_reports": [ "S208", "S209", "S206", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S208 and S209 are bibliographic records for reviews concerning rheumatic diseases. Historical review locations identifying the Leung entry, study summaries, and references are preserved.", "condition_status": "Partly verified", "status_reason": "The two DOIs or review averages were not counted as independent replications of B5 alone for FSS.", "missingness": "The two DOIs or review averages were not counted as independent replications of B5 alone for FSS.", "uncertainty": "The two DOIs or review averages were not counted as independent replications of B5 alone for FSS.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Original reports included in S208/S209, linkage to Leung, and overlap" }, { "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.", "current_reports": [ "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "ACTRN12613001087741 is a registered trial of a Swisse multicomponent multivitamin in healthy women aged 50~75. Chalder is a different secondary endpoint, and actual randomized counts and results are unverified.", "condition_status": "Partly verified", "status_reason": "Historical access to the full registration does not mean that the registration was read or direct B5 results were verified in this review.", "missingness": "Historical access to the full registration does not mean that the registration was read or direct B5 results were verified in this review.", "uncertainty": "Historical access to the full registration does not mean that the registration was read or direct B5 results were verified in this review.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "ACTRN registration, healthy women aged 50~75, multicomponent composition, and endpoint hierarchy/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.", "current_reports": [ "S214", "S215" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S214 is a mitochondrial cocktail/Gulf War illness lead, and S215 is an Alii combination-product lead; the direct pages at that time were JavaScript shells.", "condition_status": "Partly verified", "status_reason": "They were not labeled as verified full texts/results or counted as negative studies.", "missingness": "They were not labeled as verified full texts/results or counted as negative studies.", "uncertainty": "They were not labeled as verified full texts/results or counted as negative studies.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Actual text, interventions/endpoints, and results of NCT02804828 and NCT07271316" }, { "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.", "current_reports": [ "S210", "S06" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S210 is a bibliographic record of original-paper metadata/abstract concerning physical fatigue/cognitive dysfunction in mice. CoA/metabolic functions are not direct FSS effects in adults.", "condition_status": "Partly verified", "status_reason": "Only the preserved metadata/abstract was read; external original experimental tables or effects translated to humans were not verified.", "missingness": "Only the preserved metadata/abstract was read; external original experimental tables or effects translated to humans were not verified.", "uncertainty": "Only the preserved metadata/abstract was read; external original experimental tables or effects translated to humans were not verified.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Species, experimental intervention, physiological/behavioral endpoints, and limits of human applicability" }, { "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.", "current_reports": [ "S211" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S211 is a J-STAGE abstract/search-index bibliographic record of pantothenic-acid deficiency cases. It is not a comparative FSS result for a single active ingredient in nonspecific persistent fatigue.", "condition_status": "Partly verified", "status_reason": "The existence of human deficiency studies is preserved, but comparisons or effect estimates beyond that abstract are not inferred.", "missingness": "The existence of human deficiency studies is preserved, but comparisons or effect estimates beyond that abstract are not inferred.", "uncertainty": "The existence of human deficiency studies is preserved, but comparisons or effect estimates beyond that abstract are not inferred.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Deficiency diagnosis, correction, population, and assessment endpoints" }, { "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.", "current_reports": [ "S212" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S212 is at the bibliographic/search-abstract level for the early sports-vitamin study with PMID4238715 and DOI10.1007/BF00695017.", "condition_status": "Partly verified", "status_reason": "It was not used as a direct FSS result for B5 alone in nonspecific persistent fatigue.", "missingness": "It was not used as a direct FSS result for B5 alone in nonspecific persistent fatigue.", "uncertainty": "It was not used as a direct FSS result for B5 alone in nonspecific persistent fatigue.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Product composition, populations, exercise/fatigue endpoints, and actual analyses" }, { "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.", "current_reports": [ "S216" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S216 is a search-index description of ME/CFS metabolomics material, and a CAPTCHA was reported during direct access at that time.", "condition_status": "Partly verified", "status_reason": "The metabolomic bibliography/association was not used as an FSS treatment effect from administering B5 alone.", "missingness": "The metabolomic bibliography/association was not used as an FSS treatment effect from administering B5 alone.", "uncertainty": "The metabolomic bibliography/association was not used as an FSS treatment effect from administering B5 alone.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Direction of exposure, disease, metabolomic findings, and whether a direct intervention exists" }, { "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.", "current_reports": [ "S217" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "S217 is a search-index bibliographic record of examples in patent US5304574A.", "condition_status": "Partly verified", "status_reason": "Directly eligible between-group FSS results, samples, and independence were not verified from this bibliographic record.", "missingness": "Directly eligible between-group FSS results, samples, and independence were not verified from this bibliographic record.", "uncertainty": "Directly eligible between-group FSS results, samples, and independence were not verified from this bibliographic record.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Populations, experiments, and independent clinical results in the US5304574A examples" }, { "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.", "current_reports": [ "S06", "S201", "S202", "S203", "S204", "S205", "S206", "S207", "S208", "S209", "S210", "S211", "S212", "S213", "S214", "S215", "S216", "S217" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The complete preserved archived summary for 3101 was actually read in this review. NIH inherited extraction, partial PMC access followed by a CAPTCHA, author uploads, visual PDF inspection, full-text access to reviews/registrations, and search indexes are reports from the manuscript at that time. No external materials were attempted or read in this review.", "condition_status": "Met", "status_reason": "No report-specific access-date field exists, so it was left empty and distinguished from the original review date of 2026-09-15.", "missingness": "No report-specific access-date field exists, so it was left empty and distinguished from the original review date of 2026-09-15.", "uncertainty": "No report-specific access-date field exists, so it was left empty and distinguished from the original review date of 2026-09-15.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Identity, current locations/values/SHA read, and historical access/dates for each material" }, { "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.", "current_reports": [ "S201", "S202", "S204", "S205", "S207" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "axes.no_human_study=true and human_study_exists=false apply to the fixed direct single-ingredient FSS comparison. related_human_studies_exist=true and search_exhaustive=false are also explicitly stated in the original text.", "condition_status": "Met", "status_reason": "Do not delete related human studies of combination products/specific diseases or interpret the record as a worldwide absence of human evidence.", "missingness": "Do not delete related human studies of combination products/specific diseases or interpret the record as a worldwide absence of human evidence.", "uncertainty": "Do not delete related human studies of combination products/specific diseases or interpret the record as a worldwide absence of human evidence.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Original flags, scope, directly eligible/related human-study existence, and search limitations" }, { "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.", "current_reports": [], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The original efficacy grade is ?, the score is empty, and the 7 axes are B/P/empty/empty/empty/empty/empty. The subsequent 5 axes and strength count are unscored, not 0. The document_quality B in the original self-review is also separate.", "condition_status": "Met", "status_reason": "Condition statuses, report counts, and original document assessments were not turned into new scores or official certification.", "missingness": "Condition statuses, report counts, and original document assessments were not turned into new scores or official certification.", "uncertainty": "Condition statuses, report counts, and original document assessments were not turned into new scores or official certification.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Original grade/score, application of each axis, gate rationale, and historical calculation references" }, { "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.", "current_reports": [ "S201", "S202", "S204", "S205", "S207", "S213" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "For Ullah, the Esserre product and company-employee authorship are reported; for Brouwers, Numico supply/manufacture and author affiliation are reported. Full funding and patent information are unverified. Lupus-study funding is also unverified, and the full Swisse COI information was not reviewed for an efficacy conclusion.", "condition_status": "Partly verified", "status_reason": "Do not transfer related-product sponsorship information to the independence axis of a single-active-ingredient trial.", "missingness": "Do not transfer related-product sponsorship information to the independence axis of a single-active-ingredient trial.", "uncertainty": "Do not transfer related-product sponsorship information to the independence axis of a single-active-ingredient trial.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Product provision, manufacture, company affiliations, research funding, patents, and disclosed COI" }, { "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.", "current_reports": [ "S213", "S214", "S215" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Preregistration and analysis plans for a direct single-active-ingredient FSS comparison are unverified within the preserved scope. The full related registration and CTG shell are distinct levels of material.", "condition_status": "Unverified", "status_reason": "Do not establish that selective reporting occurred or that registration was absent from gaps in direct plans.", "missingness": "Do not establish that selective reporting occurred or that registration was absent from gaps in direct plans.", "uncertainty": "Do not establish that selective reporting occurred or that registration was absent from gaps in direct plans.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Eligible single-active-ingredient trial registration, protocol, SAP, reasons for changes, and all results" }, { "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.", "current_reports": [], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The selected question in this review is the between-group FSS effect in the fixed population. Optimal dose, persistence after discontinuation, and efficacy in all special populations are separate extension questions and were not adopted as additional requirements.", "condition_status": "Not applicable", "status_reason": "Gaps in verification of the duration and population needed for the claim remain unverified under the earlier items.", "missingness": "Gaps in verification of the duration and population needed for the claim remain unverified under the earlier items.", "uncertainty": "Gaps in verification of the duration and population needed for the claim remain unverified under the earlier items.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Separate direct dose comparisons, follow-up after discontinuation, and prespecified subgroups/interactions" }, { "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.", "current_reports": [ "S06" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The original preserved NIH description mentions the possibility of diarrhea and gastrointestinal discomfort with high-dose B5. The 10 g/day example is not a toxicity threshold/dosing recommendation, and the adequate intake of 5 mg/day is a nutritional reference value. Harm collection, arm-specific denominators/discontinuations, and causality for a single active ingredient used for this fatigue purpose are unverified.", "condition_status": "Partly verified", "status_reason": "The absence of an established upper limit does not mean unlimited safety. Do not transfer combination-product adverse effects or pantethine bleeding cautions to B5 alone.", "missingness": "The absence of an established upper limit does not mean unlimited safety. Do not transfer combination-product adverse effects or pantethine bleeding cautions to B5 alone.", "uncertainty": "The absence of an established upper limit does not mean unlimited safety. Do not transfer combination-product adverse effects or pantethine bleeding cautions to B5 alone.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Event definitions, collection, exposure, time, denominators, arm-specific discontinuations, and concomitant use/causes" }, { "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.", "current_reports": [ "S06" ], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "Safety for long-term high-dose use for this fatigue purpose, pregnancy, lactation, children, and liver/kidney disease is unverified. The statement that no important interactions are known is also not proof of safety for all combinations.", "condition_status": "Unverified", "status_reason": "Do not turn study doses into personal dosing instructions or calculate incidence rates from general warnings.", "missingness": "Do not turn study doses into personal dosing instructions or calculate incidence rates from general warnings.", "uncertainty": "Do not turn study doses into personal dosing instructions or calculate incidence rates from general warnings.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Data on long-term exposure, rare events, pregnancy/lactation/children, liver/kidney disease, and concomitant use" }, { "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.", "current_reports": [], "existence": "Currently archived bibliography and structural/historical records exist; this is not current external verification of existence or corrections", "acquired_read": "The complete, exactly retained archived summary was actually read; external material and separate earlier original texts were not read in this review", "observation": "The evidence/original review date is 2026-09-15. This conversion of preserved material into a table is not a new search, external full-text reading, calculation, judgment, or deployment. If new single-active-ingredient trials, composition, fatigue tables, registration/SAP, corrections/retractions, or classification/numerical errors are verified, preserve the prior original text and history at the same ID/URL.", "condition_status": "Met", "status_reason": "The original document_quality B, grade_revalidated, and single-assistant self-review are original reports, not independent clinical certification in this review.", "missingness": "The original document_quality B, grade_revalidated, and single-assistant self-review are original reports, not independent clinical certification in this review.", "uncertainty": "The original document_quality B, grade_revalidated, and single-assistant self-review are original reports, not independent clinical certification in this review.", "review_date": "2026-10-05", "reading_status": "Original material not read · Archived summary read", "additional_material": "Original review date, scope actually read in the current review, new evidence/corrections, and preservation of versions/original text" } ], "reports": [ { "report_id": "S06", "title": "NIH Office of Dietary Supplements. Pantothenic Acid — Health Professional Fact Sheet", "url": "https://ods.od.nih.gov/factsheets/PantothenicAcid-HealthProfessional/", "report_type": "NIH nutrition/safety description", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Official_nutrition_safety", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Description of nutritional reference values, high-dose GI effects, absence of an established upper limit, and interactions; not a direct FSS trial", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S06-M1", "url": null, "parent_url": null }, { "material_type": "NIH ODS official web document", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: inherited_full_text_extraction. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Table 1; Health Risks from Excessive Pantothenic Acid; Interactions with Medications", "material_id": "S06-M2", "url": "https://ods.od.nih.gov/factsheets/PantothenicAcid-HealthProfessional/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://ods.od.nih.gov/factsheets/PantothenicAcid-HealthProfessional/" } ] }, { "report_id": "S201", "title": "Ullah et al. Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10343643/", "report_type": "Bibliography for the original combination-product RCT", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F01", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "58 participants, 29 per arm; FSS improvement reported; contribution of B5 alone and FSS analysis denominator unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S201-M1", "url": null, "parent_url": null }, { "material_type": "PMC full-text page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: full_text_partial_retrieval_then_captcha. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Methods, Sections 2.1 and 2.2; abstract; full text initially read, later detailed retrieval blocked", "material_id": "S201-M2", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10343643/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10343643/" } ] }, { "report_id": "S202", "title": "Ullah et al. PubMed record and abstract for the same randomized trial", "url": "https://pubmed.ncbi.nlm.nih.gov/37447210/", "report_type": "PubMed bibliography/abstract for the same RCT", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F01", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Same DOI/PMID as S201; product/company-affiliated authors; not an independent trial", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S202-M1", "url": null, "parent_url": null }, { "material_type": "PubMed bibliography/abstract", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: abstract. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Abstract; conflict-of-interest statement; metadata; reference 5", "material_id": "S202-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/37447210/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/37447210/" } ] }, { "report_id": "S203", "title": "Esposito et al. Chemical Characterization and Preliminary Evaluation of a Pomegranate Extract, B Vitamins and Vitamin C Supplement", "url": "https://www.mdpi.com/2227-9717/10/2/208", "report_type": "Product-characterization/preliminary-evaluation bibliography", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F02_Related_product_cohort_unknown", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "S202 reference 5; original-text details/cohort linkage unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S203-M1", "url": null, "parent_url": null }, { "material_type": "Publisher article page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: metadata_and_citing_reference_full_text_failed. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Search-index metadata; cited reference 5 of S202", "material_id": "S203-M2", "url": "https://www.mdpi.com/2227-9717/10/2/208", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.mdpi.com/2227-9717/10/2/208" } ] }, { "report_id": "S204", "title": "Brouwers et al. The effect of a polynutrient supplement on fatigue and physical activity of patients with chronic fatigue syndrome", "url": "https://pubmed.ncbi.nlm.nih.gov/12324640/", "report_type": "PubMed bibliography/abstract for the CFS combination product", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F03", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Related report of nonsignificant CIS findings; not a direct single-active-ingredient FSS trial", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S204-M1", "url": null, "parent_url": null }, { "material_type": "PubMed bibliography/abstract", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: abstract. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Abstract and bibliographic metadata", "material_id": "S204-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/12324640/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/12324640/" } ] }, { "report_id": "S205", "title": "Brouwers et al. Author-uploaded primary paper, QJM 95:677–683", "url": "https://www.researchgate.net/publication/11115445_The_effect_of_a_polynutrient_supplement_on_fatigue_and_physical_activity_of_patients_with_chronic_fatigue_syndrome_a_double-blind_randomized_controlled_trial", "report_type": "Bibliography for the author upload of the same CFS combination-product study", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F03", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "53 participants, 27/26; 48 completed; no detected CIS difference; not an additional independent trial", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S205-M1", "url": null, "parent_url": null }, { "material_type": "Author-shared full-text page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: full_text_author_upload. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Methods pp.678–679; Results pp.680–681; Tables 1–4", "material_id": "S205-M2", "url": "https://www.researchgate.net/publication/11115445_The_effect_of_a_polynutrient_supplement_on_fatigue_and_physical_activity_of_patients_with_chronic_fatigue_syndrome_a_double-blind_randomized_controlled_trial", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.researchgate.net/publication/11115445_The_effect_of_a_polynutrient_supplement_on_fatigue_and_physical_activity_of_patients_with_chronic_fatigue_syndrome_a_double-blind_randomized_controlled_trial" } ] }, { "report_id": "S206", "title": "Leung. Systemic lupus erythematosus: a combined deficiency disease. Medical Hypotheses 62:922–924", "url": "https://pubmed.ncbi.nlm.nih.gov/15142649/", "report_type": "Bibliography for the 2004 lupus case report", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F04_Possible_overlap", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Overlap with the 2007 cases unknown; historical metadata and failed full-text access", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S206-M1", "url": null, "parent_url": null }, { "material_type": "PubMed bibliographic page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: metadata_search_index_full_text_failed. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Indexed metadata and DOI; PubMed page CAPTCHA; publisher access failed", "material_id": "S206-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/15142649/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/15142649/" } ] }, { "report_id": "S207", "title": "Leung. Systemic Lupus Erythematosus: A Combined Deficiency Disease. Journal of Orthomolecular Medicine 22(4)", "url": "https://isom.ca/wp-content/uploads/2020/02/JOM_2007_22_4_06_Systemic_Lupus_Erythematosus_A_Combined_Deficiency-.pdf", "report_type": "Bibliography for the 2007 lupus multiple-vitamin cases", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F04_Possible_overlap", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "12 women; calcium pantothenate 10 g/day/concomitant vitamins; control/FSS absent or unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S207-M1", "url": null, "parent_url": null }, { "material_type": "Publisher PDF link", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: full_text_pdf_and_visual_page. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Clinical observations, printed p.213, PDF page index 11; observed visually", "material_id": "S207-M2", "url": "https://isom.ca/wp-content/uploads/2020/02/JOM_2007_22_4_06_Systemic_Lupus_Erythematosus_A_Combined_Deficiency-.pdf", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://isom.ca/wp-content/uploads/2020/02/JOM_2007_22_4_06_Systemic_Lupus_Erythematosus_A_Combined_Deficiency-.pdf" } ] }, { "report_id": "S208", "title": "De Carvalho and Martinez. Pantothenic acid (vitamin B5) supplementation in rheumatological diseases: A systematic reviews", "url": "https://www.spandidos-publications.com/10.3892/ijfn.2025.53", "report_type": "Bibliography for the 2025 rheumatology-related review", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Review_rheumatology", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Leung entry/included studies; no duplicate counting alongside original studies", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S208-M1", "url": null, "parent_url": null }, { "material_type": "Publisher review full-text page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: review_full_text. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Eligibility criteria; Table I; Leung entry; references", "material_id": "S208-M2", "url": "https://www.spandidos-publications.com/10.3892/ijfn.2025.53", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.spandidos-publications.com/10.3892/ijfn.2025.53" } ] }, { "report_id": "S209", "title": "De Carvalho and Martinez. Pantothenic acid and rheumatological disease review", "url": "https://www.sciltp.com/journals/jmai/articles/2512002425", "report_type": "Bibliography for a rheumatology review with a different DOI", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Review_rheumatology", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Study summary/references; not an independent single-active-ingredient FSS trial", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S209-M1", "url": null, "parent_url": null }, { "material_type": "Publisher review full-text page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: review_full_text. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Study summary and references", "material_id": "S209-M2", "url": "https://www.sciltp.com/journals/jmai/articles/2512002425", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.sciltp.com/journals/jmai/articles/2512002425" } ] }, { "report_id": "S210", "title": "Nakagawasai et al. Effect of Calcium Pantothenate on Physical Fatigue and Cognitive Dysfunction in Mice", "url": "https://cir.nii.ac.jp/crid/1390282681269860864", "report_type": "Metadata/abstract for the original mouse report", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Nonhuman_mice", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "physical fatigue/cognitive dysfunction; not attributed to human FSS", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S210-M1", "url": null, "parent_url": null }, { "material_type": "Official scholarly-index page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: primary_metadata_and_abstract. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: CiNii abstract linked to J-STAGE original", "material_id": "S210-M2", "url": "https://cir.nii.ac.jp/crid/1390282681269860864", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://cir.nii.ac.jp/crid/1390282681269860864" } ] }, { "report_id": "S211", "title": "Yoshitoshi et al. Pantothenic-acid-deficiency case report", "url": "https://www.jstage.jst.go.jp/article/jsnfs1949/16/6/16_6_564/_article/-char/ja", "report_type": "Bibliography for the B5-deficiency case-report abstract", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Deficiency_cases", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Correction of a specific deficiency; separate from nonspecific persistent fatigue", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S211-M1", "url": null, "parent_url": null }, { "material_type": "Journal abstract page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: primary_abstract_search_index. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: J-STAGE abstract, 16(6):564–571", "material_id": "S211-M2", "url": "https://www.jstage.jst.go.jp/article/jsnfs1949/16/6/16_6_564/_article/-char/ja", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.jstage.jst.go.jp/article/jsnfs1949/16/6/16_6_564/_article/-char/ja" } ] }, { "report_id": "S212", "title": "Early sports-vitamin supplementation study", "url": "https://pubmed.ncbi.nlm.nih.gov/4238715/", "report_type": "Older sports-vitamin bibliography", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Exercise_lead", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Exercise material; single-active-ingredient FSS details/eligibility unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S212-M1", "url": null, "parent_url": null }, { "material_type": "PubMed bibliographic page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: metadata_and_abstract_search_index. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Indexed abstract; associated publisher abstract", "material_id": "S212-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/4238715/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/4238715/" } ] }, { "report_id": "S213", "title": "ANZCTR. Understanding the behavioural effects of multivitamin supplements: The BEMS study in women", "url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365064", "report_type": "Bibliography for the multicomponent BEMS registration", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "F05", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Healthy women aged 50~75/secondary Chalder outcome; actual allocation/results unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S213-M1", "url": null, "parent_url": null }, { "material_type": "ANZCTR registration page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: registry_full_text. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Registration number; intervention; eligibility; outcome hierarchy; allocation methods", "material_id": "S213-M2", "url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365064", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365064" } ] }, { "report_id": "S214", "title": "ClinicalTrials.gov. NCT02804828, mitochondrial cocktail/Gulf War illness lead", "url": "https://clinicaltrials.gov/study/NCT02804828", "report_type": "Gulf War illness cocktail registration lead", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Registry_lead02804828", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Search lead/JS shell at the time; not verification of a single-active-ingredient FSS plan", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S214-M1", "url": null, "parent_url": null }, { "material_type": "ClinicalTrials.gov registration page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: search_index_then_registry_shell. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Search-index intervention lead; direct page JavaScript shell", "material_id": "S214-M2", "url": "https://clinicaltrials.gov/study/NCT02804828", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT02804828" } ] }, { "report_id": "S215", "title": "ClinicalTrials.gov. NCT07271316, Alii supplement study lead", "url": "https://clinicaltrials.gov/study/NCT07271316", "report_type": "Alii mixed-product registration lead", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Registry_lead07271316", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Search lead/JS shell at the time; actual results unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S215-M1", "url": null, "parent_url": null }, { "material_type": "ClinicalTrials.gov registration page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: search_index_then_registry_shell. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Search-index mixed-product lead; direct page JavaScript shell", "material_id": "S215-M2", "url": "https://clinicaltrials.gov/study/NCT07271316", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT07271316" } ] }, { "report_id": "S216", "title": "ME/CFS metabolomics report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6030047/", "report_type": "ME/CFS metabolomics search lead", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Association_metabolomics", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Historical search index/CAPTCHA; must not be reversed into an FSS intervention effect", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S216-M1", "url": null, "parent_url": null }, { "material_type": "PMC full-text page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: search_index_then_captcha. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Search-index metabolomics description only", "material_id": "S216-M2", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6030047/", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6030047/" } ] }, { "report_id": "S217", "title": "US5304574A patent", "url": "https://patents.google.com/patent/US5304574A/en", "report_type": "US5304574A patent search bibliography", "existence": "A reference in the archived bibliography/historical records; the current external response was not verified.", "acquired_read": "The corresponding Korean/English summaries and bibliographic records in the archived manuscript were read. The linked external original materials were not read in this review.", "study_family": "Patent_lead", "independent_replication": "18 bibliographic records ≠ 18 independent trials. The same full text/abstract, potentially overlapping cases/preliminary products, reviews, registration/search/patent/official documents/animal data are distinguished; new participant summations performed: 0", "observed_result": "Patent examples; independent clinical results/sample unverified", "result_level": "This is content recorded in the archived manuscript. It is not the result of a fresh comparison against current external original material.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Preserved archived-summary bibliography, linked summary/historical access", "public_status": "Locally preserved", "access_status": "Acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The corresponding bibliography and linked summary in the archived manuscript were read. This does not mean that the full text of the original clinical article, protocol, or official document itself was acquired or read.", "material_id": "S217-M1", "url": null, "parent_url": null }, { "material_type": "Patent web page", "public_status": "Unverified (external lookups in this review 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "No attempt was made to access this external original material or read its original text in this review. The address recorded in the bibliography is a route to the source; cases with no address or only a domain landing page were also left unchanged. Historical access level in the bibliography: patent_search_index. The actual historical access date for each material is unverified. The archived manuscript's review date of 2026-09-15 is not the access date of the original material. Historical location: Patent examples", "material_id": "S217-M2", "url": "https://patents.google.com/patent/US5304574A/en", "parent_url": null } ], "links": [ { "label": "Source", "url": "https://patents.google.com/patent/US5304574A/en" } ] } ], "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" }, "study_overlap": { "state": "This list links materials that may overlap. The seven groups do not mean seven independent clinical trials. S201, S202: F01: excluded from direct scoring; directly eligible=False / S204, S205: F03: excluded from direct scoring; directly eligible=False / S206, S207: F04: excluded from direct scoring; directly eligible=False / S213: F05: excluded from direct scoring; directly eligible=False / S203: related-product preliminary evaluation; exact cohort linkage with S201/202 unverified/independent summations performed: 0 / S208, S209, S206, S207: rheumatology reviews/repeat citations of original lupus cases/overlap between 2004 and 2007 unknown/independent summations performed: 0 / S06, S210, S211, S212, S214, S215, S216, S217: official nutrition, nonhuman/deficiency/exercise/registry-shell/metabolomics/patent leads; not counted as direct single-active-ingredient FSS replications. S201 and S202 are the same Ullah combination-product trial, and S204 and S205 are the same Brouwers CFS combination-product trial. The cohort linkage of the S203 preliminary evaluation and overlap between the S206/S207 lupus cases are unverified. Report counts are not summed as independent trial counts or total participant counts.", "unique_trial_count": null, "unique_participant_count": null, "reason": "This list links materials that may overlap. The seven groups do not mean seven independent clinical trials. S201, S202: F01: excluded from direct scoring; directly eligible=False / S204, S205: F03: excluded from direct scoring; directly eligible=False / S206, S207: F04: excluded from direct scoring; directly eligible=False / S213: F05: excluded from direct scoring; directly eligible=False / S203: related-product preliminary evaluation; exact cohort linkage with S201/202 unverified/independent summations performed: 0 / S208, S209, S206, S207: rheumatology reviews/repeat citations of original lupus cases/overlap between 2004 and 2007 unknown/independent summations performed: 0 / S06, S210, S211, S212, S214, S215, S216, S217: official nutrition, nonhuman/deficiency/exercise/registry-shell/metabolomics/patent leads; not counted as direct single-active-ingredient FSS replications. S201 and S202 are the same Ullah combination-product trial, and S204 and S205 are the same Brouwers CFS combination-product trial. The cohort linkage of the S203 preliminary evaluation and overlap between the S206/S207 lupus cases are unverified. Report counts are not summed as independent trial counts or total participant counts." }, "history": [ { "date": "2026-11-02", "kind": "Separation of the public view and data", "view_version": "1.0", "change": "A public view and data were prepared from the existing 40 items. No new clinical search, change in verification status, or scoring was performed." } ], "language": "en", "translation_date": "2026-11-02" }