Vitamin B12 (actual chemical form unverified) × Reduction of CIS subjective-fatigue score in adults with IBD-related fatigue

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Independent claimHas the question of CIS subjective fatigue in IBD been linked as a single unit?Required	The assessment concerns reduction of the CIS subjective-fatigue score for IBD-related fatigue. It was linked as a single question comparing oral B12 as the sole added therapy with placebo. The actual subclaims field is an empty list, and no new claim about another endpoint was created. S01 S05	The population, route, comparator and endpoint in the Korean manuscript and facets support this question boundary. This does not mean eligible IBD results have been acquired.	Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints. Materials needed: the current claim, facets and identity manuscript, and the complete preceding version if the scope changes.	When a new claim is requested, separate its population, route, comparator, endpoint and time point, and first review the relationship between the original ID and the question.
2	Partly verified	Full text not readStored summary read	N02 · Report familyHas the family relationship between the same reports and the provisional registration been confirmed?Required	S01 is the original Scholten2018 abstract, and S02·S16 record republications of the abstract. S03 is the corresponding full-text link, and S04 NL-OMON34980 is a provisional linkage. The S05 record of excluding Scholten2018 is not added as a new IBD trial. S01 S02 S03 S04 S05 S16	TF01 and the level of access to abstract reproductions are preserved, but the record states that family matching through the direct S04 record failed even at that time.	Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication. Materials needed: article DOI/PMID, original registry record, review table of excluded studies and report linkage table.	Compare authors, periods, populations and registration identities in the original reports to update the family table, retaining unconfirmed linkages as candidates.
3	Met	Full text not readStored summary read	N03 · Actual readingHas reading summaries in this run been distinguished from past access to abstracts and full texts?Required	The current 16 Korean fields, structured evidence and 17 citations were read as retained stored summaries. Access levels such as primary_abstract, PDF/HTML full text and registry search leads are historical records in the existing manuscript. Access to external abstracts, full texts, registrations and official documents was not attempted in this run; none were acquired or read. S01 S02 S03 S04 S05 S06 S07 S08 S09 S10 S11 S12 S13 S14 S15 S16 S17	The local stored summaries actually read were separated from the external materials not read, and the source SHA is not presented as the SHA of an original article/PDF.	Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level. Materials needed: current input bytes, row-level pointers and records of reading/accessing each original material.	For each subsequently permitted actual access event, separately record the material type, attempt result, sections read and date, and distinguish these from summary links.
4	Met	Full text not readStored summary read	N04 · Search and correction scopeHas the absence of verified direct results been limited to the historical search scope?Required	The original search/access cutoff date is 2026-09-16. evidence_status preserves both the existence of human research and the lack of verified directly eligible results, and records absence_proven=false. The record of finding nothing in a correction search by title/DOI is also not a complete integrity audit. No new search was conducted in this run. S01 S05 S17	Statements of absence were tied to the source cutoff date and search scope, and distinguished from the current review date on which no new lookup occurred.	State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run. Materials needed: original search/access records from that time, title/DOI-specific correction-check records and subsequent update events.	When a new search is authorized, record search strategies, dates, registry/unpublished/correction routes and failures, and compare the existing results as well.
5	Unverified	Full text not readStored summary read	N05 · Directness for the IBD stratumHave separate fatigue results and arm-specific analysis denominators for the IBD stratum been verified?Required	Scholten2018 analyzed IBS and IBD together. The manuscript records that no between-group estimate for the IBD stratum could be verified in the original abstract, and that the S05 review excluded the same trial because a separate analysis was unavailable. S01 S05	Mixed-cohort numerical values are available, but between-group results and analysis denominators for the selected IBD stratum are not linked.	Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results. Materials needed: IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table.	First compare the prespecified IBD analysis in the existing trial and the feasibility of separating the original data; in a separate study, prespecify the IBD diagnosis and causes of fatigue.
6	Partly verified	Full text not readStored summary read	N06 · Population selectionCan age and fatigue criteria and IBD diagnosis/activity be verified?Required	The related trial is recorded as enrolling IBS/IBD outpatients aged 18–65 years with fatigue interfering with daily activities. IBD diagnostic criteria, assessor, Crohn/UC, activity/remission, fatigue duration and Hb/anemia criteria are null. S01 S02 S03 S04	Age and the fatigue description are preserved, but details of clinical selection for the target IBD population are unverified.	Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration. Materials needed: inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information.	Compare the selection table defining IBD type, activity and causes of fatigue, and consider prespecified stratification and representativeness in future comparisons.
7	Partly verified	Full text not readStored summary read	N07 · Baseline B12 statusCan the serum B12 criterion and functional baseline status both be verified?Required	The trial's serum B12 eligibility criterion is ≥150 pmol/L. assay, MMA, homocysteine, holotranscobalamin, folate, the Hb/anemia definition and metformin/PPI/malabsorption information are unverified. This criterion alone does not establish functional sufficiency. S01 S13	The serum criterion is verified, but information needed to determine whether fatigue is related to deficiency and to establish functional status is unavailable.	Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status. Materials needed: serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information.	Compare baseline status separately by test, and prespecify hypotheses about effect modification by status when a new comparison is needed.
8	Unverified	Full text not readStored summary read	N08 · Molecule and formulationHave the actual B12 chemical form, product and single-ingredient composition been verified?Required	The manuscript names only B12 as the added active ingredient, but the actual chemical form among cyanocobalamin, methylcobalamin, hydroxocobalamin and adenosylcobalamin is unverified. Product, salt, batch, purity, tablet/capsule and release form are also null; the tablet mentioned in a registry search lead was not confirmed as the actual formulation. S01 S02 S03 S04	The selected question's single-ingredient boundary is fixed, but original materials needed to verify the identity of the product actually administered are unavailable.	Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered. Materials needed: trial product label/composition, batch, administration manual, protocol and original official registry record.	Compare the product actually administered with planning documents to separate active ingredients, chemical form and formulation, and design comparisons between preparations as a separate question.
9	Met	Full text not readStored summary read	N09 · Route of administrationHas oral administration been distinguished from results for other routes?Required	actual_trial_fields retains route=oral and cites S01 Objective as its source. The manuscript separates intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this oral IBD question. S01 S10 S11	The boundary between the reported oral route and excluded routes was verified. The corresponding original sources were not reread in this run.	Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures. Materials needed: the original abstract's Objective, administration procedures and actual methods in reports of other routes.	Link each report's route to the exposure table, and consider a separate design holding compound, population and endpoint constant only when a comparison between routes is requested.
10	Partly verified	Full text not readStored summary read	N10 · Dose and exposureHave the nominal daily dose and actual intake and frequency been verified?Required	1000 µg/day and daily are preserved, and the manuscript records this as 1 mg/day. Dose at 1 time, daily frequency, adherence, actual cumulative exposure and diet/fortified foods/additional B12 are unverified. The record that separate loading/maintenance phases were not described in the original abstract also does not prove that there were no such phases. S01 S03 S04	The nominal daily dose is verified, but actual exposure and the intake schedule are not linked.	Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases. Materials needed: administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information.	Compare the existing trial's nominal prescription with intake records, and separate a direct dose-response question into a distinct randomized comparison.
11	Partly verified	Full text not readStored summary read	N11 · Placebo comparisonCan placebo composition and matching be verified?Required	Placebo control and double blinding are reported. comparator.type is placebo, ingredients is null, and the record states that physical composition was not verified. S01 S02 S03	The comparator's name is verified, but original materials on exact placebo composition and matching are unavailable.	Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups. Materials needed: placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks.	Compare the composition, appearance and administration of the actual placebo and active preparation to examine what difference the named comparison introduced.
12	Unverified	Full text not readStored summary read	N12 · Background treatmentHave arm-specific IBD management, concomitant treatments and rescue treatment been verified?Required	The target comparison uses placebo with identical background management. However, names/doses of common treatments in the original abstract, background_balance, rescue and adherence are unverified. S01 S03 S04	Materials needed to verify treatment differences other than the selected intervention and their analytical handling are unavailable.	Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest. Materials needed: arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records.	Compare the existing arm-specific management table and analytical handling, and prespecify principles for common management and rescue treatment in subsequent comparisons.
13	Partly verified	Full text not readStored summary read	N13 · Observation time pointCan the 8-week observation, prespecified primary time point and follow-up scope be verified?Required	Trial duration and measurement horizon are reported as 8 weeks. prospectively_verified_primary_time=false, and the manuscript also states that 8 weeks has not been verified through registration as the sole primary time point. S01 S03 S04	The reported 8 weeks are verified, but the prespecified primary time-point hierarchy and follow-up scope are unverified.	Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects. Materials needed: visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data.	Compare planned visits with reported results, and design separate follow-up after discontinuation only when sustained effects are requested.
14	Met	Full text not readStored summary read	N14 · CIS definitionHave the number of subjective-fatigue items, range and direction been preserved?Required	The manuscript describes CIS subjective fatigue as a total of 8 items ranging from 8–56 points, with higher scores indicating greater severity. actual_trial_fields also preserves item_count=8, range=[8,56], direction=higher_worse. S01 S06 S07	The selected measure's definition and score direction are explicit, and historical verification locations in S06/S07 were linked.	Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity. Materials needed: CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point.	Compare the scale definition with the actual trial questionnaire/results columns to verify that they use the same score unit.
15	Partly verified	Full text not readStored summary read	N15 · Recall and importanceHave the 2-week recall period, trial language and important difference in IBD been distinguished?Required	recall_weeks=2 and recall_is_symptom_duration=false are recorded. trial_language, version and MCID_applicable_to_target_estimator are null. No MCID was imported from another disease or scale. S01 S06 S07	The distinction between recall and the duration requirement for entry is verified, but the actual trial version and target MCID cannot be established.	Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate. Materials needed: trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD.	Compare the original questionnaire instructions, and separately review anchor-based evidence of importance appropriate to the population and estimate.
16	Partly verified	Full text not readStored summary read	N16 · Endpoint hierarchyHas the prespecified hierarchy of CIS fatigue, motivation and other subscales been verified?Required	The original abstract names fatigue(CIS) as primary, but the exact prespecified subscale hierarchy is unverified. The manuscript preserves a favorable result for the separate motivation subscale without repurposing it as a subjective-fatigue effect. Depression, quality of life, vitality, serum B12 and Hb are also excluded endpoints. S01 S03 S04	Boundaries between endpoints are verified, but the prespecified hierarchy, multiplicity and numerical values/denominators for the separate motivation outcome cannot be verified in this retained content.	Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results. Materials needed: protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents.	Compare the prespecified hierarchy with all reported subscales, and separate analyses and interpretations by outcome.
17	Partly verified	Full text not readStored summary read	N17 · Allocation and designHave the actual randomized design, sequence and allocation concealment been verified?Required	evidence records the original abstract of a randomized placebo-controlled trial. The KO assessment retains both the reports of randomization and double blinding and the unverified sequence and allocation concealment. S01 S02 S03	The design designation is preserved, but materials on the actual sequence, concealment and baseline balance are unavailable.	Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance. Materials needed: original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table.	Compare existing allocation documents and the baseline table, and apply only assessment questions appropriate to the design.
18	Partly verified	Full text not readStored summary read	N18 · Subjective measurementHave blinding, the scale and collection conditions for fatigue measurement been verified?Required	Randomization, double blinding and use of the CIS fatigue subscale are reported. Physical placebo composition, trial language/version and actual assessment procedures are unverified. S01 S03 S06 S07	A design and measure are named, but verification of identical measurement across arms and maintained blinding remains outstanding.	Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint. Materials needed: questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks.	Compare questionnaire/visit conditions and actual blinding to review measurement limitations by endpoint.
19	Partly verified	Full text not readStored summary read	N19 · Allocation and analysis denominatorsCan arm-specific and IBD-stratum analysis denominators also be verified beyond the total of 95 participants?Required	reported_included_total is 95 participants. randomized_by_arm, analysed_by_arm, completed_by_arm, dropout_by_arm and IBD_only are all preserved as [null,null]. S01 S02 S03	The mixed-cohort total included is verified, but the target arm-specific analysis denominators are unknown.	Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators. Materials needed: CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition.	Link participant flow to denominators in each results table to review differences among randomized, completed and analyzed populations.
20	Unverified	Full text not readStored summary read	N20 · Missing data and analysis populationCan ITT/PP, imputation and handling of attrition be verified?Required	ITT_PP, imputation, rescue, adjustment_covariates and model are null. The KO assessment also retains arm-specific denominators, ITT/PP and imputation as unverified. S01 S03 S04	The actual analysis population cannot be linked to information on handling missing data/attrition.	Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results. Materials needed: arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment.	Compare the original participant flow and analysis definitions, and plan a missing-data sensitivity review within the scope of acquired materials.
21	Partly verified	Full text not readStored summary read	N21 · Original mixed-cohort valuesCan mixed-cohort change values, the definition of ± and the type of values be verified?Required	Mixed-cohort changes are recorded as B12 −8.1 ±9.5 and placebo −8.3 ±10.6. plus_minus_type and mean_or_median_label are null. These values were not used as the IBD-stratum effect. S01 S02 S16	The reported original values are preserved, but the statistical definitions of the values and ± are unverified.	Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE. Materials needed: original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators.	Compare numerical column headings, dispersion notation and denominators in the table to verify the type of values. Do not newly calculate statistics without authorization.
22	Met	Full text not readStored summary read	N22 · Historical descriptive differenceHas the existing +0.2-point value been kept from being converted into the target IBD effect?Required	The manuscript and assessment_profile.calculation preserve +0.2 CIS points as a simple mixed-cohort difference. status is descriptive_mixed_cohort_arithmetic_only; n, SD, SE, df and the interval are null, and it is explicitly not a target-population estimator. The calculation was not executed in this run. S01 S17	The population and limitations of the existing descriptive arithmetic were stated, without elevating it to an IBD effect or a new statistical result.	Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI. Materials needed: original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators.	In an authorized subsequent review, compare original values with calculation definitions, and keep the descriptive difference and target estimand in separate columns.
23	Unverified	Full text not readStored summary read	N23 · CI attributionHas the estimate corresponding to the 95% CI −11.65~6.71 been verified?Required	The manuscript records 95% CI −11.65~6.71, but unassigned_CI_estimand is null. target_CI is also null, and this CI was not attached to the simple mixed-cohort difference of +0.2. S01 S02 S03 S16	CI values are present, but the corresponding estimand/analysis/population is unverified, so they cannot be used to judge target precision.	Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis. Materials needed: CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators.	Compare the original CI sentence and table to verify which estimand the interval concerns, then interpret it in the same units and at the same time point.
24	Unverified	Full text not readStored summary read	N24 · Target effect and precisionHave the IBD-stratum difference in change, CI and P and their relationship to importance been verified?Required	target_between_group_estimate, target_CI and target_P are null. pooled_exact_P, the model and adjustment covariates are also unverified, and the IBD between-group MCID is null as well. Preserve the original target_estimate=null and 0 directly eligible results unchanged. S01 S03 S04 S05	Without the target result and interval, importance and precision cannot be compared.	Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance. Materials needed: adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence.	First fix the target estimand and compare the results table with the analysis plan; review importance/precision only against verified criteria.
25	Unverified	Full text not readStored summary read	N25 · Registration and planHave the candidate registration's actual identity and comparison of the plan with results been verified?Required	S04 is a provisional linkage to NL-OMON34980, and the citation records registry_search_snippet_only. Direct record/PDF access failed at that time. The original trial full text, protocol, SAP and prespecified subscale and time-point hierarchy are unverified in the current input. S01 S03 S04	A candidate registration exists, but there is no evidence that the actual plan was read and compared with the report.	Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan. Materials needed: original official registry record/version, protocol/SAP and reported results/reasons for changes.	Verify dates/versions of existing registration and plans, and compare the original report's subscales, time points and analyses individually.
26	Met	Full text not readStored summary read	N26 · Nonsignificant resultsHas mixed-cohort nonsignificance been kept from being converted into an IBD effect of 0 or equivalence?Required	The original authors reported no significant between-group difference in subjective fatigue in the mixed cohort. This contrary, nonsignificant result is preserved, but the exact pooled P and IBD-stratum results are unverified. Nonsignificance was not interpreted as an IBD effect of 0 or equivalence. S01 S02 S16	The verified contrary report and interpretive limitations were retained together, without newly assessing the target effect.	Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design. Materials needed: original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis.	Compare the direction, population and estimand across all relevant results, and examine equivalence questions using a separate design with prespecified margins.
27	Unverified	Full text not readStored summary read	N27 · Eligible replicationCan independent replication results for the target IBD fatigue be verified?Required	The original count of directly eligible results is 0, and existence of human research is true. The KO assessment records replication as unevaluated because eligible results are unavailable. Articles, registration leads and reviews are not independent replications, and the replication axis is null. S01 S02 S04 S05 S08 S16	The retained scope lacks a target result set, so independent replication/heterogeneity cannot be compared.	Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants. Materials needed: eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis.	First compare direct eligibility and family identity, and compare differences in conditions/contrary results only when a new independent result is available.
28	Met	Full text not readStored summary read	N28 · Combination-product boundaryHave the favorable combination-product results in S09 been separated from the effect of B12 alone?Required	The manuscript preserves favorable results from another trial of a B-vitamin and magnesium combination, but does not repurpose them as a fatigue effect of B12 alone. The S09 citation contains only historical verification locations for Abstract, Methods and fatigue results; detailed result values/denominators are absent from this stored summary. S09	Favorable results were retained while explicitly marking the boundary between the combination product and the target single-ingredient question.	Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone. Materials needed: S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents.	Compare original combination-product reports by ingredient/population/scale, and consider comparisons separating ingredients when an individual contribution is the question.
29	Partly verified	Full text not readStored summary read	N29 · Reviews and requotationsCan the original-trial linkages and target IBD results in S05/S08 be verified?Required	S05 records the exclusion of Scholten2018 because IBS/IBD results were not separated. S08 is a citation containing a historical verification location in a transcription of a systematic review of cognition, depression and fatigue; detailed results/included-trial materials were not separately retained in this stored summary. S05 S08	The S05 exclusion reason is linked to the manuscript, but S08 target eligibility and study-specific results cannot be judged from location records alone.	Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary. Materials needed: review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results.	Compare the linkage table between reviews and original reports to group the same trials/requotations, and separately verify only eligible comparisons.
30	Met	Full text not readStored summary read	N30 · Other fatigue studiesHave intranasal ME/CFS, sublingual fibromyalgia and protocol materials been separated?Required	The manuscript explicitly distinguishes intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this claim. S12 is a protocol search citation, and direct full-text access failed at that time. Detailed response values from original materials and S12 completed results were not newly filled in during this run. S10 S11 S12	The scope of documents concerning other populations, routes, before-and-after observations and plans was separated from the target oral IBD between-group results.	Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results. Materials needed: S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report.	Distinguish population, route, controlled/before-and-after comparison and plan/results for each report in an identity table, and review the eligible IBD question separately.
31	Met	Full text not readStored summary read	N31 · Mechanisms and clinical extensionHave serum increases, anemia recovery and vitality been kept from replacing CIS fatigue?Supplementary; required for extended claims	The manuscript does not use a role in energy metabolism, increased serum B12, correction of anemia or experiences of vitality as substitute evidence for a CIS fatigue effect versus placebo. The patient-reported symptom score in this table is not extended to hospitalization, complications, death or Hb recovery. S01 S10 S11 S17	The boundary between the selected endpoint and other questions was preserved, without creating unverified results for other events.	Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score. Materials needed: endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question.	Separate current fatigue results from other endpoints, and first define a distinct population, comparator and time frame if an event/anemia/vitality question is requested.
32	Unverified	Full text not readStored summary read	N32 · Funding and interestsHas the actual scope of disclosures for funding, product supply and COI been verified?Supplementary; required for claims of independence	Funding sources and product supply are unverified in the manuscript. funding, product_supply, employee_authors and patents are null, and the record states that a publisher-index lead was not treated as a complete COI disclosure. S01 S03 S16	Without the actual original disclosures, independence or the level of funding cannot be established.	State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI. Materials needed: original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures.	Compare original disclosures with product supply and institutional relationships, record only the verified level, and separate this from replication-family identity.
33	Unverified	Full text not readStored summary read	N33 · Trial harms and denominatorsHave arm-specific adverse events, serious adverse events, discontinuations and denominators in the oral trial been verified?Supplementary; required for safety questions	actual_trial_fields.safety records 8 weeks and leaves events_by_arm, SAE_by_arm and AE_discontinuations_by_arm all as [null,null]. status explicitly states that these were not reported/unverified in the original abstract, not 0. S01 S03	Within the retained original-abstract content read, arm-specific harm and discontinuation counts and denominators cannot be verified.	Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up. Materials needed: arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up.	Compare original safety collection with events/persons and denominators, and prespecify systematic collection, discontinuation reasons and losses to follow-up in future comparisons.
34	Met	Full text not readStored summary read	N34 · UL and general safetyHas the absence of an established UL for B12 been kept from being converted into an unlimited safety guarantee?Supplementary; required for extensions of safety claims	The original safety statement explicitly says that the absence of an established UL is not an unlimited safety guarantee. S13 retains historical full-text HTML verification locations for Health Risks, Medication interactions and B12 status assessment, but was not directly read in this run. S13	The interpretive scope of the absent UL and official documents/trial results were separated. Gaps in direct harms evidence were not erased.	Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data. Materials needed: the relevant S13 safety/status/medication sections and direct harms data by exposure and population.	Compare the scope of judgments in official documents with the direct trial's population, duration and collection methods; consider suitable separate designs for rare and long-term harms.
35	Met	Full text not readStored summary read	N35 · Cobalt and chemical formHave the chemical forms covered by the cobalt-sensitivity notice been preserved?Supplementary; required for the relevant scope of harms	The manuscript links the cobalt-sensitivity notice to hydroxocobalamin and cyanocobalamin. S14 cites the corresponding official drug-safety-update HTML and was not repurposed as incidence in this oral trial with an unverified chemical form. S14	The official notice's chemical-form boundary and the unverified target preparation were preserved together.	Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified. Materials needed: preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data.	Compare preparations and exposures in the notice with the trial product to review applicability, and separate allergy/alternative explanations in the harms record.
36	Met	Full text not readStored summary read	N36 · Injection-label boundaryHave the injectable product's Leber and hypokalemia warnings been separated from oral incidence?Supplementary; required for extensions of safety claims	Leber optic neuropathy and hypokalemia early in intensive treatment of severe megaloblastic anemia are recorded in the context of the cyanocobalamin injection label accessed for the manuscript. They were not transferred to event rates in the oral trial whose chemical form is unverified. S15	The warnings' route and treatment context were retained and separated from direct harms observations in the target trial.	Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms. Materials needed: S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data.	Compare the official label's route, disease and treatment phase with the target exposure to distinguish the scope of harms warnings.
37	Does not apply	Full text not readStored summary read	N37 · Extension to longer durations and vulnerable groupsAre long-term, vulnerable-group and optimal-dose data required for this 8-week fatigue question?Supplementary; required for extended claims	The current unit is the reported 8-week CIS fatigue comparison in a restricted adult population. The manuscript does not generalize 8 weeks to the safety of long-term high doses or use in pregnancy/lactation, children or liver/kidney disease, and does not use the study dose as an instruction for individual dosing or treatment changes. S01 S13 S14 S15	This is an applicability exception: long-term/special-population/optimal-dose trials are not imposed as required conditions for the narrow symptom question. It does not indicate that evidence for those extensions has been verified.	Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope. Materials needed: data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials.	Define a separate population, exposure and follow-up/comparison only when an extended question is requested, and consider suitable observational/comparative designs for rare/long-term harms.
38	Met	Full text not readStored summary read	N38 · Original assessment and calculation historyHave 0 directly eligible results, the existence of human research, ?/null and the legacy gate been separated?Required	The original grade is ? and score is null. no_human_study=false, existence of human research=true, directly eligible results are 0, and downstream axes are null. The manuscript records disclosure of the legacy calculator's diagnostics for the original factual profile and a separate nonempirical gate projection. Neither the history nor the conceptual symptom P was transferred into a score/grade for the new table. S17	The separation of the original assessment from factual/compatibility records was preserved. The calculator/audit was not rerun and the grade was not validated in this run.	Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score. Materials needed: the current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record.	When an authorized correction is needed, separate the factual profile, compatibility mapping and calculation event, and preserve before/after values and reasons. No reassessment is performed in this run.
39	Met	Full text not readStored summary read	N39 · Operational metadata and updatesHave original ID/URL, document quality and deployment metadata been distinguished from completion of the current table?Required	Link the 3114 ID and current canonical. Original document A and single-assistant self-review are separate from efficacy ?. The original stored summary retains needs_id_assignment alongside assigned, and initial unpublished/first_published_at=null alongside server_deployed=true and deployed_at=2026-09-16. These were not elevated to actual publication of the current table, and original values were not corrected. S17	Different labels in the original metadata were preserved, and current stored-summary production, QA by another author, derived formats, UI and publication were marked as separate stages.	Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events. Materials needed: original identity/operational metadata, actual publication records and revision triggers/original-version preservation records.	When operational facts are updated, compare actual records with original metadata, and distinguish criterion revisions, evidence additions and output/publication events.

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39 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence cut-off: 2026-09-16
Scope actually checked: Stored Korean and English manuscripts and case-specific criteria and application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of an up-to-date clinical literature search.
Population: Age 18–65 years, with IBD-related fatigue interfering with daily activities; the trial criterion of serum B12 ≥150 pmol/L. Not combined with IBS; detailed diagnosis, duration and functional deficiency status unverified
Ingredient, formulation and route: Vitamin B12 as the sole added active ingredient; actual chemical form unverified; oral B12 supplement; tablet, capsule, release form and product unverified; the tablet mentioned in a registry search lead is not confirmed as the actual formulation; oral; distinguished from sublingual, intramuscular, intravenous, intranasal and transdermal administration
Dose: 1000 µg/day; dose at 1 time, number of administrations per day and actual cumulative exposure unverified
Comparator: Placebo; the aim is identical background management, but common treatments and placebo composition in the original abstract are unverified
Measured outcome: Between-group difference in change/adjusted estimate at 8 weeks for the CIS subjective-fatigue subscale total score (8–56 points, higher scores indicate greater severity); IBD-stratum results and prespecified subscale hierarchy unverified
Duration: Reported 8 weeks; hierarchy of the preregistered primary time point unverified
Questions outside this scope: The question was narrowed to subjective fatigue in IBD alone. Hb recovery in B12-deficiency anemia, vitality in healthy people, intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia differ from this claim. The score from the existing B12 assessment was therefore not carried over unchanged. [S01; S10; S11; S17]

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Scholten2018 mixed-trial original abstract

Source

Material type: Original trial abstract
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: Mixed cohort of 95 participants; oral B12 1000 µg/day; CIS fatigue at 8 weeks. Changes of −8.1 ±9.5 and −8.3 ±10.6 and the report of nonsignificance are preserved. The existing +0.2 descriptive difference is not an IBD effect, and the estimate corresponding to the 95% CI −11.65~6.71 is also unverified.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article abstract Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.
Full-text article PDF Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S02 · Scholten2018 institutional republication of the abstract

Source

Material type: Institutional abstract web page
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The citation records the institution's reproduction of the original abstract and verification locations for abstract/journal and DOI metadata. The manuscript summary of the same mixed trial is preserved, but this stored summary contains no separate detailed S02 results text.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Institutional article-abstract web page Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.
Full-text article PDF Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S03 · Scholten2018 publisher full-text link

Source

Material type: Publisher PDF link
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The publisher PDF/HTML endpoint and inaccessible_full_text remain in the historical citation. This input does not mark original full-text results as separately acquired, and access was not attempted in this run.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text article PDF Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S04 · NL-OMON34980 provisional registration

Source

Material type: Official registration candidate
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: NL-OMON34980 is a candidate linkage, with failure of direct record access recorded at that time. Only search-title/summary leads are available; the tablet lead is not elevated to verification of the actual formulation or a prespecified primary time point.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full original web registry record Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S05 · Record of Scholten2018 exclusion in the IBD fatigue review

Source

Material type: Systematic review PDF
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript records that the Cochrane review excluded Scholten2018 because IBS/IBD results were not separated. Historical verification locations are the excluded-studies table at printed p67/physical page72(0-index71) and printed p20. This is not a no-effect result for IBD.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text systematic review PDF Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S06 · Article defining CIS fatigue measurement

Source

Material type: Scale-definition article HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: Linked to S06/S07, the manuscript preserves CIS subjective fatigue as 8 items, 8–56 points, higher scores indicating greater severity, and a 2-week recall period. The S06 Methods fatigue measurement location record is not a target IBD effect result.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text scale-definition article on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S07 · Official CIS-Fatigue scale guide

Source

Material type: Official scale-guide HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The historical verification location CIS-Fatigue table web lines233–266 is retained. The scale definition is distinguished from the unverified trial language/version and target IBD MCID; thresholds from another disease are not imported.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full official scale guide on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S08 · Transcription of the B12 cognition, depression and fatigue review

Source

Material type: Systematic review transcription web page
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The citation records Section3.6, Table1 Schlichtiger1996, reference81 and systematic_review_full_text_transcription. Detailed S08 results/included-trial tables were not separately retained in this stored summary, so no target eligible results or new replication count is created.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full review transcription on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S09 · Related fatigue report for a B-vitamin and magnesium combination

Source

Material type: Related original article HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript preserves favorable results from another trial of a B-vitamin and magnesium combination, but does not repurpose them as a fatigue effect of B12 alone. The citation contains only the sections checked; detailed composition, denominators and effect estimates are absent from this input.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text article on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S10 · Related observations of intranasal administration in ME/CFS

Source

Material type: Related original article HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript separates intranasal administration in ME/CFS from this question. The citation preserves historical verification locations for Abstract, Methods and responder analysis, but responder counts/proportions and target IBD results cannot be verified from this input.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text article on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S11 · Sublingual before-and-after observations in fibromyalgia

Source

Material type: Related original article HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript treats sublingual before-and-after observations in fibromyalgia as a separate question. The citation's verification locations for design/population/administration, Population and Limitations are retained, without newly filling in detailed result values or denominators.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text article on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S12 · Related protocol search citation

Source

Material type: Protocol search identity
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The protocol record identified in the search index and the historical failure of direct full-text access are retained. Population, route, product, completion status/results are not established solely from the URL or protocol designation.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full protocol on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S13 · NIH ODS B12 professional fact sheet

Source

Material type: Official fact-sheet HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript states that the absence of an established UL is not an unlimited safety guarantee. Historical locations for Health Risks, Medication interactions and B12 status assessment are linked, without using them as event rates for the oral trial whose chemical form is unverified.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full fact sheet on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S14 · Official cobalt-sensitivity safety notice

Source

Material type: Official safety-notice HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: Preserve the cobalt-sensitivity notice concerning hydroxocobalamin and cyanocobalamin as in the manuscript. Do not transfer it to causality/incidence in the trial whose actual chemical form is unverified, or to individual safety.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full safety notice on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S15 · Official Cyanocobalamin injection label

Source

Material type: Drug-label HTML
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: Preserve Leber optic neuropathy and hypokalemia early in intensive treatment of severe megaloblastic anemia in the context of the injection label. Do not repurpose them as event rates in the oral fatigue trial whose chemical form is unverified.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full drug label on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S16 · Scholten2018 abstract republication and record of full text not acquired

Source

Material type: Abstract republication web page
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The citation records primary_abstract_replication_not_full_text and the notice that full text was not acquired. The manuscript's nonsignificant mixed-cohort result is retained in the same-trial context, without creating a separate independent IBD comparison or new detailed values.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article-abstract republication web page Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.
Full-text article PDF Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.

S17 · Historical identity of Chamgap methodology and the sealed audit

Source

Material type: Methodology web document and separate audit identity
Materials actually read: The retained stored summary was read; access to the corresponding original material was not attempted, and it was not acquired or read in this run
Findings recorded in the stored summary: The manuscript distinguishes the public methods overview from the sealed package's input/calculation records. It preserves the explanation of 0 directly eligible results, the existence of human research, ?/null and the legacy gate projection. The sealed audit and calculator were not read or executed in this run.
Record level: The results/attribution retained in the current source stored summary, or the scope of details not retained, were actually read. This is not current reading of the corresponding original document's full text/abstract.
Study overlap and independent replication: False

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full methodology document on the web Open material ↗	Only the manuscript's historical access-level record is preserved; no lookup in this run	Access not attempted	Not read	The retained citation identity is currently verified; the corresponding original material's current public availability/access status is not fully verified. The existing manuscript's verification cutoff date is recorded separately. Actual access dates for individual materials were not retained and are unverified. Access to original materials was not attempted in this run, and they were not acquired or read.
Separate audit material in the sealed package Material URL unverified	Unverified	Access not attempted	Not read	Identity of a separate sealed audit reported by S17/the manuscript; original bytes unverified in this run. The earlier separate document was not read in this run.

Report counts versus independent study counts

TF01 report linkages in the stored record are distinguished. Candidate registry linkages and review requotations were not counted as independent trials. The total unique trial count and total participant count are unverified.

Review criteria

Version NGM-v3114-ORAL-B12-IBD-CIS8-1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Has the question of CIS subjective fatigue in IBD been linked as a single unit?

Required materials and conditions: Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints. Materials needed: the current claim, facets and identity manuscript, and the complete preceding version if the scope changes.
Conditions for verification: Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints.
Requirement and applicability: Required
Application exceptions: Preserve the empty subclaims list as the actual structure. Do not automatically create additional subclaims for the mixed cohort, anemia, vitality or motivation.
Why this condition is needed: This identity criterion prevents the entire ingredient or all fatigue studies from being combined into a single effect.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension — an individual internal adaptation for the independent claim, not implementation of or certification by an official assessment tool.

N02 · Has the family relationship between the same reports and the provisional registration been confirmed?

Required materials and conditions: Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication. Materials needed: article DOI/PMID, original registry record, review table of excluded studies and report linkage table.
Conditions for verification: Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication.
Requirement and applicability: Required
Application exceptions: The S04 linkage is provisional. A candidate registration number alone does not confirm the same family or create new results.
Why this condition is needed: This is needed to prevent 17 citations from being converted into 17 independent trials or a unique participant count.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for the report family, not implementation of or certification by an official assessment tool.

N03 · Has reading summaries in this run been distinguished from past access to abstracts and full texts?

Required materials and conditions: Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level. Materials needed: current input bytes, row-level pointers and records of reading/accessing each original material.
Conditions for verification: Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level.
Requirement and applicability: Required
Application exceptions: Past failures for S03·S04·S12 are not failures of a current retry. The separate sealed audit in S17 was also not read in this run.
Why this condition is needed: This is needed to prevent a current full-text-read badge from being displayed solely on the basis of a URL or a past reading record.
Referenced methods: M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for actual reading, not implementation of or certification by an official assessment tool.

N04 · Has the absence of verified direct results been limited to the historical search scope?

Required materials and conditions: State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run. Materials needed: original search/access records from that time, title/DOI-specific correction-check records and subsequent update events.
Conditions for verification: State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run.
Requirement and applicability: Required
Application exceptions: An empty corrections field means only that the retained list is empty; it does not prove the absence of all corrections and retractions.
Why this condition is needed: This is needed to prevent the lack of verified directly eligible results from being extended to worldwide absence of research or a complete current search.
Referenced methods: M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for search and correction scope, not implementation of or certification by an official assessment tool.

N05 · Have separate fatigue results and arm-specific analysis denominators for the IBD stratum been verified?

Required materials and conditions: Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results. Materials needed: IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table.
Conditions for verification: Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results.
Requirement and applicability: Required
Application exceptions: Do not delete the mixed-trial results. Unverified IBD-stratum results do not mean an effect of 0, equivalence or absence of all human research.
Why this condition is needed: This is needed to prevent results including IBS from being transferred to a causal effect on IBD fatigue with a specified cause.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — an individual internal adaptation for directness for the IBD stratum, not implementation of or certification by an official assessment tool.

N06 · Can age and fatigue criteria and IBD diagnosis/activity be verified?

Required materials and conditions: Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration. Materials needed: inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information.
Conditions for verification: Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration.
Requirement and applicability: Required
Application exceptions: Do not use the fatigue scale's 2-week recall period as the fatigue-duration threshold for entry.
Why this condition is needed: This is needed to avoid assuming identical population selection and applicability solely because the same IBD label is used.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for population selection, not implementation of or certification by an official assessment tool.

N07 · Can the serum B12 criterion and functional baseline status both be verified?

Required materials and conditions: Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status. Materials needed: serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information.
Conditions for verification: Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status.
Requirement and applicability: Required
Application exceptions: Meeting the serum criterion does not mean that other functional markers are normal. Hb recovery during treatment of deficiency anemia is a separate endpoint.
Why this condition is needed: This is needed to prevent a single serum criterion from merging deficiency-related fatigue and additional supplementation without deficiency into the same question.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed — an individual internal adaptation for baseline B12 status, not implementation of or certification by an official assessment tool.

N08 · Have the actual B12 chemical form, product and single-ingredient composition been verified?

Required materials and conditions: Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered. Materials needed: trial product label/composition, batch, administration manual, protocol and original official registry record.
Conditions for verification: Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered.
Requirement and applicability: Required
Application exceptions: The absence of named additional ingredients in the original abstract differs from confirmation of a single-ingredient composition in the full text/protocol.
Why this condition is needed: This is needed to prevent different cobalamins or combination products from being treated as the same oral single-agent therapy.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for molecule and formulation, not implementation of or certification by an official assessment tool.

N09 · Has oral administration been distinguished from results for other routes?

Required materials and conditions: Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures. Materials needed: the original abstract's Objective, administration procedures and actual methods in reports of other routes.
Conditions for verification: Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures.
Requirement and applicability: Required
Application exceptions: Verification of the oral route does not establish the actual product's absorption, bioavailability or equivalence.
Why this condition is needed: This is needed to prevent before-and-after fatigue observations with intranasal or sublingual administration from being converted into oral single-agent comparative results.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for route of administration, not implementation of or certification by an official assessment tool.

N10 · Have the nominal daily dose and actual intake and frequency been verified?

Required materials and conditions: Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases. Materials needed: administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information.
Conditions for verification: Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases.
Requirement and applicability: Required
Application exceptions: Preserve the manuscript's existing record of the conversion 1000 µg=1 mg. Do not newly calculate cumulative exposure or a dose-response relationship.
Why this condition is needed: This is needed to prevent a nominal dose from being converted into actual intake or an optimal individual dose.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for dose and exposure, not implementation of or certification by an official assessment tool.

N11 · Can placebo composition and matching be verified?

Required materials and conditions: Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups. Materials needed: placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks.
Conditions for verification: Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups.
Requirement and applicability: Required
Application exceptions: Retain the report of double blinding, and do not turn unverified placebo composition into absence of a placebo.
Why this condition is needed: The placebo label alone cannot establish complete verification of active-ingredient differences and sensory blinding.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M08 §8.1–8.2.3; internal application — an individual internal adaptation for placebo comparison, not implementation of or certification by an official assessment tool.

N12 · Have arm-specific IBD management, concomitant treatments and rescue treatment been verified?

Required materials and conditions: Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest. Materials needed: arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records.
Conditions for verification: Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest.
Requirement and applicability: Required
Application exceptions: The aim of identical background management differs from verified balance in the actual trial. Do not require every change to be identical.
Why this condition is needed: This is needed to prevent differences in IBD management from being attributed to the contribution of added B12.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for background treatment, not implementation of or certification by an official assessment tool.

N13 · Can the 8-week observation, prespecified primary time point and follow-up scope be verified?

Required materials and conditions: Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects. Materials needed: visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data.
Conditions for verification: Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects.
Requirement and applicability: Required
Application exceptions: Do not impose an arbitrary minimum long-term duration on this 8-week question.
Why this condition is needed: This is needed to prevent a reported time point from being converted into the sole prespecified primary time point or a long-term sustained effect.
Referenced methods: 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 — an individual internal adaptation for observation time point, not implementation of or certification by an official assessment tool.

N14 · Have the number of subjective-fatigue items, range and direction been preserved?

Required materials and conditions: Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity. Materials needed: CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point.
Conditions for verification: Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity.
Requirement and applicability: Required
Application exceptions: Verification of the scale definition does not mean that the actual trial language, version and measurement procedures have also been verified.
Why this condition is needed: This is needed to prevent changes in total CIS or motivation scores from being converted into subjective-fatigue subscale values.
Referenced methods: 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 — an individual internal adaptation for the CIS definition, not implementation of or certification by an official assessment tool.

N15 · Have the 2-week recall period, trial language and important difference in IBD been distinguished?

Required materials and conditions: Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate. Materials needed: trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD.
Conditions for verification: Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate.
Requirement and applicability: Required
Application exceptions: Do not turn an unverified MCID into absence of a score definition, or adopt an arbitrary number.
Why this condition is needed: This is needed to prevent thresholds from another disease or scale from being imported to establish the sufficiency or clinical importance of fatigue results.
Referenced methods: M03 §3.2.1; detailed population criteria 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, M03 §3.2.4; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for recall and importance, not implementation of or certification by an official assessment tool.

N16 · Has the prespecified hierarchy of CIS fatigue, motivation and other subscales been verified?

Required materials and conditions: Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results. Materials needed: protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents.
Conditions for verification: Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results.
Requirement and applicability: Required
Application exceptions: Do not delete actual favorable reports for other endpoints because the target fatigue result was nonsignificant; retain their separate attribution.
Why this condition is needed: This is needed to prevent selection of a favorable subscale to replace the target subjective-fatigue result.
Referenced methods: 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; separation of statuses is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application — an individual internal adaptation for endpoint hierarchy, not implementation of or certification by an official assessment tool.

N17 · Have the actual randomized design, sequence and allocation concealment been verified?

Required materials and conditions: Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance. Materials needed: original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table.
Conditions for verification: Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily mark crossover/cluster considerations as inapplicable or reclassify the study as nonrandomized because design details are unavailable.
Why this condition is needed: This is needed to avoid concluding from the RCT label that allocation-related bias or baseline differences have been resolved.
Referenced methods: M08 §8.1–8.2.3; internal application; M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for allocation and design, not implementation of or certification by an official assessment tool.

N18 · Have blinding, the scale and collection conditions for fatigue measurement been verified?

Required materials and conditions: Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint. Materials needed: questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks.
Conditions for verification: Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint.
Requirement and applicability: Required
Application exceptions: Do not treat the double-blind designation as confirmation of fully maintained blinding, or conclude failure solely because details are unverified.
Why this condition is needed: This is needed to distinguish differences in measurement of subjective outcomes from actual outcome differences.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.1–8.2.3; internal application — an individual internal adaptation for subjective measurement, not implementation of or certification by an official assessment tool.

N19 · Can arm-specific and IBD-stratum analysis denominators also be verified beyond the total of 95 participants?

Required materials and conditions: Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators. Materials needed: CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition.
Conditions for verification: Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators.
Requirement and applicability: Required
Application exceptions: When denominators are unavailable, do not estimate arm-specific counts; preserve only the descriptive total.
Why this condition is needed: This is needed to avoid dividing the mixed-cohort total in half or assuming that all were analyzed participants with IBD.
Referenced methods: 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 — an individual internal adaptation for allocation and analysis denominators, not implementation of or certification by an official assessment tool.

N20 · Can ITT/PP, imputation and handling of attrition be verified?

Required materials and conditions: Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results. Materials needed: arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment.
Conditions for verification: Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results.
Requirement and applicability: Required
Application exceptions: Unverified baseline/analysis details do not mean that there was no attrition in either arm or that bias is established.
Why this condition is needed: This is needed to prevent missing denominators from being converted into complete follow-up or an ITT analysis.
Referenced methods: 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; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for missing data and analysis population, not implementation of or certification by an official assessment tool.

N21 · Can mixed-cohort change values, the definition of ± and the type of values be verified?

Required materials and conditions: Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE. Materials needed: original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators.
Conditions for verification: Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE.
Requirement and applicability: Required
Application exceptions: Retain the original values as the corresponding mixed-cohort changes without deleting them. Do not convert them into absolute baseline/end values or a between-group estimate.
Why this condition is needed: This is needed to prevent the displayed ± from being assumed to be SD and used to create precision or a target IBD effect.
Referenced methods: 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; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for original mixed-cohort values, not implementation of or certification by an official assessment tool.

N22 · Has the existing +0.2-point value been kept from being converted into the target IBD effect?

Required materials and conditions: Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI. Materials needed: original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators.
Conditions for verification: Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI.
Requirement and applicability: Required
Application exceptions: The calculation audit/tools are not executed or separately read in this run. Preserving the original arithmetic value alone does not constitute a claim of reproducibility verification.
Why this condition is needed: This is needed to prevent earlier descriptive calculations from being presented as a new calculation in this run or a directly eligible estimate.
Referenced methods: 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for the historical descriptive difference, not implementation of or certification by an official assessment tool.

N23 · Has the estimate corresponding to the 95% CI −11.65~6.71 been verified?

Required materials and conditions: Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis. Materials needed: CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators.
Conditions for verification: Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis.
Requirement and applicability: Required
Application exceptions: Preserve both the original notation and the unverified attribution, without deleting the CI or calculating a new interval.
Why this condition is needed: This is needed to prevent an unattributed CI from being attached as the interval for the existing +0.2 or the IBD-stratum effect.
Referenced methods: 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for CI attribution, not implementation of or certification by an official assessment tool.

N24 · Have the IBD-stratum difference in change, CI and P and their relationship to importance been verified?

Required materials and conditions: Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance. Materials needed: adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence.
Conditions for verification: Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance.
Requirement and applicability: Required
Application exceptions: Do not adopt sample-size/duration thresholds or a new grade while the MCID, model and target values remain unverified.
Why this condition is needed: This is needed to prevent effect size or sufficiency from being inferred solely from total sample size, nonsignificance or an unattributed CI.
Referenced methods: 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 — an individual internal adaptation for target effect and precision, not implementation of or certification by an official assessment tool.

N25 · Have the candidate registration's actual identity and comparison of the plan with results been verified?

Required materials and conditions: Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan. Materials needed: original official registry record/version, protocol/SAP and reported results/reasons for changes.
Conditions for verification: Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan.
Requirement and applicability: Required
Application exceptions: Do not repurpose the S04 tablet lead or past access failure as the actual formulation or a current access failure.
Why this condition is needed: This is needed to avoid claiming that a prior plan is verified solely from a registry search lead, or establishing nonregistration from an access failure.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for registration and plan, not implementation of or certification by an official assessment tool.

N26 · Has mixed-cohort nonsignificance been kept from being converted into an IBD effect of 0 or equivalence?

Required materials and conditions: Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design. Materials needed: original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis.
Conditions for verification: Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design.
Requirement and applicability: Required
Application exceptions: Do not convert nonsignificant subjective fatigue into absence of a separate motivation result.
Why this condition is needed: This is needed to avoid hiding contrary results or establishing no effect solely from nonsignificance.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for nonsignificant results, not implementation of or certification by an official assessment tool.

N27 · Can independent replication results for the target IBD fatigue be verified?

Required materials and conditions: Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants. Materials needed: eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis.
Conditions for verification: Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants.
Requirement and applicability: Required
Application exceptions: Do not convert the absence of verified eligible results into absence of heterogeneity across all studies or Not applicable for applicability across conditions.
Why this condition is needed: This is needed to prevent 17 materials or multiple reports of a single trial from being converted into independent replication.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for eligible replication, not implementation of or certification by an official assessment tool.

N28 · Have the favorable combination-product results in S09 been separated from the effect of B12 alone?

Required materials and conditions: Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone. Materials needed: S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents.
Conditions for verification: Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone.
Requirement and applicability: Required
Application exceptions: Do not delete favorable indirect results either. Do not fill in doses, denominators or effect estimates absent from the current stored summary by estimation.
Why this condition is needed: This is needed to prevent results from a trial containing other active ingredients from being attributed to single-ingredient efficacy.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for the combination-product boundary, not implementation of or certification by an official assessment tool.

N29 · Can the original-trial linkages and target IBD results in S05/S08 be verified?

Required materials and conditions: Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary. Materials needed: review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results.
Conditions for verification: Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary.
Requirement and applicability: Required
Application exceptions: Do not create new results or a unique trial count solely from the S08 location record of Section3.6, Table1 Schlichtiger1996 and reference81.
Why this condition is needed: This is needed to prevent the number of review documents from being converted into a count of new independent effect replications.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for reviews and requotations, not implementation of or certification by an official assessment tool.

N30 · Have intranasal ME/CFS, sublingual fibromyalgia and protocol materials been separated?

Required materials and conditions: Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results. Materials needed: S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report.
Conditions for verification: Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results.
Requirement and applicability: Required
Application exceptions: Do not establish the population, product or completed results solely from the S12 search citation. Do not fill in responder counts absent from the current stored summary.
Why this condition is needed: This is needed to prevent response observations in other diseases and routes or planning documents from being converted into completed oral IBD RCT results.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; 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 — an individual internal adaptation for other fatigue studies, not implementation of or certification by an official assessment tool.

N31 · Have serum increases, anemia recovery and vitality been kept from replacing CIS fatigue?

Required materials and conditions: Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score. Materials needed: endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question.
Conditions for verification: Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score.
Requirement and applicability: Supplementary; required for extended claims
Application exceptions: Do not require all event trials for the selected symptom-score question; review them separately when a claim is extended.
Why this condition is needed: This is needed to prevent a metabolic role or correction of anemia from being converted into direct benefit for the target fatigue versus placebo.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed — an individual internal adaptation for mechanisms and clinical extension, not implementation of or certification by an official assessment tool.

N32 · Has the actual scope of disclosures for funding, product supply and COI been verified?

Required materials and conditions: State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI. Materials needed: original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures.
Conditions for verification: State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI.
Requirement and applicability: Supplementary; required for claims of independence
Application exceptions: Do not automatically exclude results because a COI lead exists, or conclude absence of bias because none is available.
Why this condition is needed: This is needed to prevent unverified funding from being converted into independent funding or proof of independent replication.
Referenced methods: Chamgap's internal independence and attribution criteria. The official methods sections used in this pilot do not endorse every detail of this item; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for funding and interests, not implementation of or certification by an official assessment tool.

N33 · Have arm-specific adverse events, serious adverse events, discontinuations and denominators in the oral trial been verified?

Required materials and conditions: Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up. Materials needed: arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up.
Conditions for verification: Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up.
Requirement and applicability: Supplementary; required for safety questions
Application exceptions: Do not extend what could not be verified in the original abstract to nonreporting throughout the full article. Do not delete original efficacy values because of gaps in harms information.
Why this condition is needed: This is needed to avoid establishing absence of events or safety simply because safety events are absent from an efficacy summary.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed — an individual internal adaptation for trial harms and denominators, not implementation of or certification by an official assessment tool.

N34 · Has the absence of an established UL for B12 been kept from being converted into an unlimited safety guarantee?

Required materials and conditions: Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data. Materials needed: the relevant S13 safety/status/medication sections and direct harms data by exposure and population.
Conditions for verification: Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data.
Requirement and applicability: Supplementary; required for extensions of safety claims
Application exceptions: An official-document link or historical reading record does not constitute access to the official original in this run or verification of the trial's event rate.
Why this condition is needed: This is needed to prevent water solubility or the absence of a UL from being converted into safety evidence for a particular high oral dose, population or duration.
Referenced methods: M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for UL and general safety, not implementation of or certification by an official assessment tool.

N35 · Have the chemical forms covered by the cobalt-sensitivity notice been preserved?

Required materials and conditions: Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified. Materials needed: preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data.
Conditions for verification: Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified.
Requirement and applicability: Supplementary; required for the relevant scope of harms
Application exceptions: Do not interpret an unverified chemical form as meaning there is no cobalt sensitivity.
Why this condition is needed: This is needed to prevent a warning for a particular chemical form from being converted into confirmed events or incidence in this trial.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for cobalt and chemical form, not implementation of or certification by an official assessment tool.

N36 · Have the injectable product's Leber and hypokalemia warnings been separated from oral incidence?

Required materials and conditions: Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms. Materials needed: S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data.
Conditions for verification: Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms.
Requirement and applicability: Supplementary; required for extensions of safety claims
Application exceptions: Do not delete the warnings or add incidence or individual dosing instructions.
Why this condition is needed: This is needed to prevent warnings in the context of injections and intensive anemia treatment from being converted into causality/frequency for another oral exposure.
Referenced methods: M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for the injection-label boundary, not implementation of or certification by an official assessment tool.

N37 · Are long-term, vulnerable-group and optimal-dose data required for this 8-week fatigue question?

Required materials and conditions: Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope. Materials needed: data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials.
Conditions for verification: Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope.
Requirement and applicability: Supplementary; required for extended claims
Application exceptions: Do not require every long-term/vulnerable-group/dose study for the reported 8-week fatigue question.
Why this condition is needed: This is a supplementary boundary to prevent short-term reports in a restricted population from being converted into overall safety and dosing recommendations.
Referenced methods: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for extension to longer durations and vulnerable groups, not implementation of or certification by an official assessment tool.

N38 · Have 0 directly eligible results, the existence of human research, ?/null and the legacy gate been separated?

Required materials and conditions: Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score. Materials needed: the current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record.
Conditions for verification: Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score.
Requirement and applicability: Required
Application exceptions: The S17 sealed audit and calculator are not read or executed in this run. Do not fill a null scoring axis with the conceptual symptom P.
Why this condition is needed: This is needed to prevent unverified direct eligibility from being converted into no_human_study=true, or document quality/historical calculations from being inherited as an efficacy score.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for original assessment and calculation history, not implementation of or certification by an official assessment tool.

N39 · Have original ID/URL, document quality and deployment metadata been distinguished from completion of the current table?

Required materials and conditions: Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events. Materials needed: original identity/operational metadata, actual publication records and revision triggers/original-version preservation records.
Conditions for verification: Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events.
Requirement and applicability: Required
Application exceptions: Do not silently reconcile semantic_code_status and assigned labels, or server_deployed and initial unpublished/null time records, even when they coexist.
Why this condition is needed: This is needed to prevent document A, past self-review and deployment labels from being converted into clinical certification or completed publication of the current table.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed — an individual internal adaptation for operational metadata and updates, not implementation of or certification by an official assessment tool.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.
Extent of review: Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.
Extent of review: Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.
Extent of review: Reuse of the actual bytes/SHA of the methods HTML copies retained for 1585 and of historical principles. This is not new full-text reading of methods, official implementation or certification in this run.

What the statuses mean

Met: The criterion's identity, retained attribution and interpretive boundaries have been verified. This does not establish clinical efficacy, safety or official certification.
Partly verified: Some facts concerning the criterion are retained, but comparison of required axes/original materials remains outstanding.
Unverified: The required values/materials cannot be established within the retained content read. This does not mean 0 studies/effect/events.
Does not apply: An extension requirement that does not apply to the required conditions of the current narrow question. It does not mean the materials are verified or substitute for Not read.
Not applicable: An extension requirement that does not apply to the required conditions of the current narrow question.
Not read: The corresponding original material was not directly read in this run. This is distinguished from actual reading of the local stored summary.
Not reported: An information gap limited to the material/section read. This is not a conclusion that the information is absent throughout the original article.
Inaccessible: Used only when an actual current failure is recorded; current access not attempted and historical failures are distinguished.
Conflicting information: Marked only when an actual discrepancy is linked to the same question/analysis.
Review incomplete: Individual review for table production remains outstanding; this is distinguished from Unverified/Not read material statuses.

Change history

2026-11-06 · Public page/material version 1.0

Public-facing display and data were prepared from the existing 39 items. No new clinical search, change to verification statuses or scoring was performed.

The stored-material review date (2026-10-05) and original evidence cut-off (2026-09-16) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Has the question of CIS subjective fatigue in IBD been linked as a single unit?

Current findings: The assessment concerns reduction of the CIS subjective-fatigue score for IBD-related fatigue. It was linked as a single question comparing oral B12 as the sole added therapy with placebo. The actual subclaims field is an empty list, and no new claim about another endpoint was created.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The population, route, comparator and endpoint in the Korean manuscript and facets support this question boundary. This does not mean eligible IBD results have been acquired.
Reason for missing information: The chemical form and IBD-only results and denominators remain separately unverified.
Required materials and conditions: Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints. Materials needed: the current claim, facets and identity manuscript, and the complete preceding version if the scope changes.
Materials to obtain first: The current claim, facets and identity manuscript, and the complete preceding version if the scope changes.
Further research: When a new claim is requested, separate its population, route, comparator, endpoint and time point, and first review the relationship between the original ID and the question.
Remaining uncertainty: Establishing an independent production unit differs from verifying clinical efficacy.
Conditions for verification: Link the original /ko/effect to oral B12 as the sole added therapy versus placebo in adults with IBD, with the reported between-group difference in CIS subjective-fatigue change at 8 weeks, and distinguish other populations and endpoints.
Why this condition is needed: This identity criterion prevents the entire ingredient or all fatigue studies from being combined into a single effect.
Application exceptions: Preserve the empty subclaims list as the actual structure. Do not automatically create additional subclaims for the mixed cohort, anemia, vitality or motivation.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension — an individual internal adaptation for the independent claim, not implementation of or certification by an official assessment tool.

Related sources S01 S05

N02 · Has the family relationship between the same reports and the provisional registration been confirmed?

Current findings: S01 is the original Scholten2018 abstract, and S02·S16 record republications of the abstract. S03 is the corresponding full-text link, and S04 NL-OMON34980 is a provisional linkage. The S05 record of excluding Scholten2018 is not added as a new IBD trial.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: TF01 and the level of access to abstract reproductions are preserved, but the record states that family matching through the direct S04 record failed even at that time.
Reason for missing information: Confirmation of the provisional registry linkage and comparison of the original identities of all related reports remain outstanding.
Required materials and conditions: Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication. Materials needed: article DOI/PMID, original registry record, review table of excluded studies and report linkage table.
Materials to obtain first: Article DOI/PMID, original registry record, review table of excluded studies and report linkage table.
Further research: Compare authors, periods, populations and registration identities in the original reports to update the family table, retaining unconfirmed linkages as candidates.
Remaining uncertainty: The number of related materials is not the same as the totals of unique studies and unique participants; the latter remain unconfirmed.
Conditions for verification: Group the S01·S02·S16 abstracts and S03 full-text link into the same report family, and do not count the S04 candidate registration or S05 review requotation as independent replication.
Why this condition is needed: This is needed to prevent 17 citations from being converted into 17 independent trials or a unique participant count.
Application exceptions: The S04 linkage is provisional. A candidate registration number alone does not confirm the same family or create new results.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for the report family, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03 S04 S05 S16

N03 · Has reading summaries in this run been distinguished from past access to abstracts and full texts?

Current findings: The current 16 Korean fields, structured evidence and 17 citations were read as retained stored summaries. Access levels such as primary_abstract, PDF/HTML full text and registry search leads are historical records in the existing manuscript. Access to external abstracts, full texts, registrations and official documents was not attempted in this run; none were acquired or read.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The local stored summaries actually read were separated from the external materials not read, and the source SHA is not presented as the SHA of an original article/PDF.
Reason for missing information: Current external original-source bytes, current public availability and reading records for this run are unavailable.
Required materials and conditions: Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level. Materials needed: current input bytes, row-level pointers and records of reading/accessing each original material.
Materials to obtain first: Current input bytes, row-level pointers and records of reading/accessing each original material.
Further research: For each subsequently permitted actual access event, separately record the material type, attempt result, sections read and date, and distinguish these from summary links.
Remaining uncertainty: The historical access_level is the level reported by the manuscript at that time, not a result of revalidation in this run.
Conditions for verification: Link the locations in the source stored summaries read in this run, and separate each external material's current access not attempted, not acquired and not read states from its historical access_level.
Why this condition is needed: This is needed to prevent a current full-text-read badge from being displayed solely on the basis of a URL or a past reading record.
Application exceptions: Past failures for S03·S04·S12 are not failures of a current retry. The separate sealed audit in S17 was also not read in this run.
Referenced methods: M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for actual reading, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03 S04 S05 S06 S07 S08 S09 S10 S11 S12 S13 S14 S15 S16 S17

N04 · Has the absence of verified direct results been limited to the historical search scope?

Current findings: The original search/access cutoff date is 2026-09-16. evidence_status preserves both the existence of human research and the lack of verified directly eligible results, and records absence_proven=false. The record of finding nothing in a correction search by title/DOI is also not a complete integrity audit. No new search was conducted in this run.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Statements of absence were tied to the source cutoff date and search scope, and distinguished from the current review date on which no new lookup occurred.
Reason for missing information: The separate audit, past search records and access_log.json were not read in this run, and not all subsequent publications/corrections were checked.
Required materials and conditions: State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run. Materials needed: original search/access records from that time, title/DOI-specific correction-check records and subsequent update events.
Materials to obtain first: Original search/access records from that time, title/DOI-specific correction-check records and subsequent update events.
Further research: When a new search is authorized, record search strategies, dates, registry/unpublished/correction routes and failures, and compare the existing results as well.
Remaining uncertainty: Distinguish limitations of the recorded search from absolute absence of research.
Conditions for verification: State the evidence cutoff date and the limits of the search and correction checks at that time, without implying that a new search was conducted in this run.
Why this condition is needed: This is needed to prevent the lack of verified directly eligible results from being extended to worldwide absence of research or a complete current search.
Application exceptions: An empty corrections field means only that the retained list is empty; it does not prove the absence of all corrections and retractions.
Referenced methods: M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for search and correction scope, not implementation of or certification by an official assessment tool.

Related sources S01 S05 S17

N05 · Have separate fatigue results and arm-specific analysis denominators for the IBD stratum been verified?

Current findings: Scholten2018 analyzed IBS and IBD together. The manuscript records that no between-group estimate for the IBD stratum could be verified in the original abstract, and that the S05 review excluded the same trial because a separate analysis was unavailable.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Mixed-cohort numerical values are available, but between-group results and analysis denominators for the selected IBD stratum are not linked.
Reason for missing information: The IBD-stratum difference in change, CI, P and arm-specific analysis denominators are unverified.
Required materials and conditions: Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results. Materials needed: IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table.
Materials to obtain first: IBD-stratum results table, arm-specific denominators, separate analysis plan and the original S05 excluded-studies table.
Further research: First compare the prespecified IBD analysis in the existing trial and the feasibility of separating the original data; in a separate study, prespecify the IBD diagnosis and causes of fatigue.
Remaining uncertainty: Exclusion from a review does not mean no effect in IBD.
Conditions for verification: Actual separate results and analysis denominators for the IBD stratum are required before they can be used as the target between-group effect; retain the indirectness of mixed-cohort results.
Why this condition is needed: This is needed to prevent results including IBS from being transferred to a causal effect on IBD fatigue with a specified cause.
Application exceptions: Do not delete the mixed-trial results. Unverified IBD-stratum results do not mean an effect of 0, equivalence or absence of all human research.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M08 §8.2.2, M15 §15.3.1; internal application — an individual internal adaptation for directness for the IBD stratum, not implementation of or certification by an official assessment tool.

Related sources S01 S05

N06 · Can age and fatigue criteria and IBD diagnosis/activity be verified?

Current findings: The related trial is recorded as enrolling IBS/IBD outpatients aged 18–65 years with fatigue interfering with daily activities. IBD diagnostic criteria, assessor, Crohn/UC, activity/remission, fatigue duration and Hb/anemia criteria are null.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Age and the fatigue description are preserved, but details of clinical selection for the target IBD population are unverified.
Reason for missing information: Diagnosis, activity, anemia/other causes and the fatigue-duration threshold are unverified.
Required materials and conditions: Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration. Materials needed: inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information.
Materials to obtain first: Inclusion/exclusion table, IBD diagnosis/assessor, Crohn/UC, activity, anemia and fatigue-duration information.
Further research: Compare the selection table defining IBD type, activity and causes of fatigue, and consider prespecified stratification and representativeness in future comparisons.
Remaining uncertainty: Without selection details, generalization to all patients with IBD is not possible.
Conditions for verification: Distinguish the reported age and fatigue interfering with daily activities from actual IBD diagnosis, activity, anemia/mixed causes and duration.
Why this condition is needed: This is needed to avoid assuming identical population selection and applicability solely because the same IBD label is used.
Application exceptions: Do not use the fatigue scale's 2-week recall period as the fatigue-duration threshold for entry.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for population selection, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03 S04

N07 · Can the serum B12 criterion and functional baseline status both be verified?

Current findings: The trial's serum B12 eligibility criterion is ≥150 pmol/L. assay, MMA, homocysteine, holotranscobalamin, folate, the Hb/anemia definition and metformin/PPI/malabsorption information are unverified. This criterion alone does not establish functional sufficiency.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The serum criterion is verified, but information needed to determine whether fatigue is related to deficiency and to establish functional status is unavailable.
Reason for missing information: The assay, functional markers and baseline information on anemia/absorption and medications remain outstanding.
Required materials and conditions: Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status. Materials needed: serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information.
Materials to obtain first: Serum assay, baseline distribution, functional B12/folate, Hb and malabsorption/medication assessment information.
Further research: Compare baseline status separately by test, and prespecify hypotheses about effect modification by status when a new comparison is needed.
Remaining uncertainty: A measured serum criterion and a clinically sufficient state are not the same information.
Conditions for verification: Verify separately the serum eligibility criterion of ≥150 pmol/L, assay, MMA, homocysteine, holotranscobalamin, folate and anemia status.
Why this condition is needed: This is needed to prevent a single serum criterion from merging deficiency-related fatigue and additional supplementation without deficiency into the same question.
Application exceptions: Meeting the serum criterion does not mean that other functional markers are normal. Hb recovery during treatment of deficiency anemia is a separate endpoint.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed — an individual internal adaptation for baseline B12 status, not implementation of or certification by an official assessment tool.

Related sources S01 S13

N08 · Have the actual B12 chemical form, product and single-ingredient composition been verified?

Current findings: The manuscript names only B12 as the added active ingredient, but the actual chemical form among cyanocobalamin, methylcobalamin, hydroxocobalamin and adenosylcobalamin is unverified. Product, salt, batch, purity, tablet/capsule and release form are also null; the tablet mentioned in a registry search lead was not confirmed as the actual formulation.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The selected question's single-ingredient boundary is fixed, but original materials needed to verify the identity of the product actually administered are unavailable.
Reason for missing information: Chemical form, physical formulation, manufacturer/batch and complete active-ingredient composition are unverified.
Required materials and conditions: Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered. Materials needed: trial product label/composition, batch, administration manual, protocol and original official registry record.
Materials to obtain first: Trial product label/composition, batch, administration manual, protocol and original official registry record.
Further research: Compare the product actually administered with planning documents to separate active ingredients, chemical form and formulation, and design comparisons between preparations as a separate question.
Remaining uncertainty: Efficacy or official warnings for another chemical form cannot automatically be transferred to this preparation's results or incidence.
Conditions for verification: Verify the actual chemical form, number of active ingredients, product/manufacturer/batch, physical formulation and release form, and distinguish registry search leads from the formulation actually administered.
Why this condition is needed: This is needed to prevent different cobalamins or combination products from being treated as the same oral single-agent therapy.
Application exceptions: The absence of named additional ingredients in the original abstract differs from confirmation of a single-ingredient composition in the full text/protocol.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for molecule and formulation, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03 S04

N09 · Has oral administration been distinguished from results for other routes?

Current findings: actual_trial_fields retains route=oral and cites S01 Objective as its source. The manuscript separates intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this oral IBD question.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The boundary between the reported oral route and excluded routes was verified. The corresponding original sources were not reread in this run.
Reason for missing information: Details of oral product administration and absorption data remain separately unverified.
Required materials and conditions: Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures. Materials needed: the original abstract's Objective, administration procedures and actual methods in reports of other routes.
Materials to obtain first: The original abstract's Objective, administration procedures and actual methods in reports of other routes.
Further research: Link each report's route to the exposure table, and consider a separate design holding compound, population and endpoint constant only when a comparison between routes is requested.
Remaining uncertainty: A difference in route does not itself provide evidence comparing effect sizes between routes.
Conditions for verification: Verify the source for the trial's oral route, and preserve sublingual, intranasal, intramuscular/intravenous and transdermal routes as separate exposures.
Why this condition is needed: This is needed to prevent before-and-after fatigue observations with intranasal or sublingual administration from being converted into oral single-agent comparative results.
Application exceptions: Verification of the oral route does not establish the actual product's absorption, bioavailability or equivalence.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for route of administration, not implementation of or certification by an official assessment tool.

Related sources S01 S10 S11

N10 · Have the nominal daily dose and actual intake and frequency been verified?

Current findings: 1000 µg/day and daily are preserved, and the manuscript records this as 1 mg/day. Dose at 1 time, daily frequency, adherence, actual cumulative exposure and diet/fortified foods/additional B12 are unverified. The record that separate loading/maintenance phases were not described in the original abstract also does not prove that there were no such phases.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The nominal daily dose is verified, but actual exposure and the intake schedule are not linked.
Reason for missing information: Dose at 1 time, frequency, adherence, cumulative exposure and concurrent B12 exposure remain outstanding.
Required materials and conditions: Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases. Materials needed: administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information.
Materials to obtain first: Administration/intake records, dose at 1 time/frequency, adherence, diet/fortified foods/additional B12 and loading/maintenance information.
Further research: Compare the existing trial's nominal prescription with intake records, and separate a direct dose-response question into a distinct randomized comparison.
Remaining uncertainty: Reporting a specified dose does not establish an optimal dose or provide individual dosing instructions.
Conditions for verification: Verify separately the nominal daily dose, dose at 1 time, daily frequency, adherence/cumulative exposure, dietary/additional B12 and loading/maintenance phases.
Why this condition is needed: This is needed to prevent a nominal dose from being converted into actual intake or an optimal individual dose.
Application exceptions: Preserve the manuscript's existing record of the conversion 1000 µg=1 mg. Do not newly calculate cumulative exposure or a dose-response relationship.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for dose and exposure, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N11 · Can placebo composition and matching be verified?

Current findings: Placebo control and double blinding are reported. comparator.type is placebo, ingredients is null, and the record states that physical composition was not verified.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The comparator's name is verified, but original materials on exact placebo composition and matching are unavailable.
Reason for missing information: Placebo ingredients, matching of appearance/taste and other properties, and maintenance of blinding after allocation are unverified.
Required materials and conditions: Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups. Materials needed: placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks.
Materials to obtain first: Placebo composition/manufacturing table, matching to the active preparation, administration procedures and blinding checks.
Further research: Compare the composition, appearance and administration of the actual placebo and active preparation to examine what difference the named comparison introduced.
Remaining uncertainty: Missing composition information alone cannot establish blinding failure or the magnitude of bias in the effect.
Conditions for verification: Distinguish the report of placebo control from actual placebo ingredients, physical matching and the comparison between assigned groups.
Why this condition is needed: The placebo label alone cannot establish complete verification of active-ingredient differences and sensory blinding.
Application exceptions: Retain the report of double blinding, and do not turn unverified placebo composition into absence of a placebo.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M08 §8.1–8.2.3; internal application — an individual internal adaptation for placebo comparison, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03

N12 · Have arm-specific IBD management, concomitant treatments and rescue treatment been verified?

Current findings: The target comparison uses placebo with identical background management. However, names/doses of common treatments in the original abstract, background_balance, rescue and adherence are unverified.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Materials needed to verify treatment differences other than the selected intervention and their analytical handling are unavailable.
Reason for missing information: IBD medications/diet, rescue/changes, between-arm balance and actual intake are unverified.
Required materials and conditions: Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest. Materials needed: arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records.
Materials to obtain first: Arm-specific IBD treatments, doses/changes, diet, rescue treatment, additional active ingredients and adherence records.
Further research: Compare the existing arm-specific management table and analytical handling, and prespecify principles for common management and rescue treatment in subsequent comparisons.
Remaining uncertainty: Missing information does not establish that concomitant treatment was absent or imbalanced.
Conditions for verification: Verify common IBD management, concomitant medications/diet, rescue treatment, arm-specific changes and their impact on the effect of interest.
Why this condition is needed: This is needed to prevent differences in IBD management from being attributed to the contribution of added B12.
Application exceptions: The aim of identical background management differs from verified balance in the actual trial. Do not require every change to be identical.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for background treatment, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N13 · Can the 8-week observation, prespecified primary time point and follow-up scope be verified?

Current findings: Trial duration and measurement horizon are reported as 8 weeks. prospectively_verified_primary_time=false, and the manuscript also states that 8 weeks has not been verified through registration as the sole primary time point.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The reported 8 weeks are verified, but the prespecified primary time-point hierarchy and follow-up scope are unverified.
Reason for missing information: Planned time points from the registration/protocol/SAP and data on persistence after discontinuation are unavailable.
Required materials and conditions: Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects. Materials needed: visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data.
Materials to obtain first: Visit/exposure schedule, registration history, protocol/SAP time-point hierarchy and follow-up data.
Further research: Compare planned visits with reported results, and design separate follow-up after discontinuation only when sustained effects are requested.
Remaining uncertainty: Do not generalize the existence of 8-week results to benefits or safety over a longer period.
Conditions for verification: Separate the 8 weeks of exposure/measurement from the preregistered primary time-point hierarchy, follow-up after discontinuation and sustained effects.
Why this condition is needed: This is needed to prevent a reported time point from being converted into the sole prespecified primary time point or a long-term sustained effect.
Application exceptions: Do not impose an arbitrary minimum long-term duration on this 8-week question.
Referenced methods: 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 — an individual internal adaptation for observation time point, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N14 · Have the number of subjective-fatigue items, range and direction been preserved?

Current findings: The manuscript describes CIS subjective fatigue as a total of 8 items ranging from 8–56 points, with higher scores indicating greater severity. actual_trial_fields also preserves item_count=8, range=[8,56], direction=higher_worse.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The selected measure's definition and score direction are explicit, and historical verification locations in S06/S07 were linked.
Reason for missing information: Verification of the language, version and actual questionnaire used in the trial remains separately outstanding.
Required materials and conditions: Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity. Materials needed: CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point.
Materials to obtain first: CIS subjective-fatigue definition, trial questionnaire/scoring rules and results tables by time point.
Further research: Compare the scale definition with the actual trial questionnaire/results columns to verify that they use the same score unit.
Remaining uncertainty: Verification of the definition does not provide the corresponding IBD-stratum effect estimate.
Conditions for verification: Clearly link the CIS subjective-fatigue total for 8 items, its range of 8–56 points and the direction in which higher scores indicate greater severity.
Why this condition is needed: This is needed to prevent changes in total CIS or motivation scores from being converted into subjective-fatigue subscale values.
Application exceptions: Verification of the scale definition does not mean that the actual trial language, version and measurement procedures have also been verified.
Referenced methods: 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 — an individual internal adaptation for the CIS definition, not implementation of or certification by an official assessment tool.

Related sources S01 S06 S07

N15 · Have the 2-week recall period, trial language and important difference in IBD been distinguished?

Current findings: recall_weeks=2 and recall_is_symptom_duration=false are recorded. trial_language, version and MCID_applicable_to_target_estimator are null. No MCID was imported from another disease or scale.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The distinction between recall and the duration requirement for entry is verified, but the actual trial version and target MCID cannot be established.
Reason for missing information: Trial language/version, symptom duration for entry and the target between-group MCID are unverified.
Required materials and conditions: Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate. Materials needed: trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD.
Materials to obtain first: Trial language/version, recall instructions and MCID evidence applicable to the between-group effect in IBD.
Further research: Compare the original questionnaire instructions, and separately review anchor-based evidence of importance appropriate to the population and estimate.
Remaining uncertainty: Within-group change or an MCID from another population cannot substitute for the importance of the target between-group effect.
Conditions for verification: Separate the 2-week recall period from the symptom-duration requirement for entry, and verify the actual language/version and an MCID appropriate to the target between-group estimate.
Why this condition is needed: This is needed to prevent thresholds from another disease or scale from being imported to establish the sufficiency or clinical importance of fatigue results.
Application exceptions: Do not turn an unverified MCID into absence of a score definition, or adopt an arbitrary number.
Referenced methods: M03 §3.2.1; detailed population criteria 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, M03 §3.2.4; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for recall and importance, not implementation of or certification by an official assessment tool.

Related sources S01 S06 S07

N16 · Has the prespecified hierarchy of CIS fatigue, motivation and other subscales been verified?

Current findings: The original abstract names fatigue(CIS) as primary, but the exact prespecified subscale hierarchy is unverified. The manuscript preserves a favorable result for the separate motivation subscale without repurposing it as a subjective-fatigue effect. Depression, quality of life, vitality, serum B12 and Hb are also excluded endpoints.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Boundaries between endpoints are verified, but the prespecified hierarchy, multiplicity and numerical values/denominators for the separate motivation outcome cannot be verified in this retained content.
Reason for missing information: The prespecified subscale/multiplicity plan and detailed results tables for separate endpoints remain outstanding.
Required materials and conditions: Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results. Materials needed: protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents.
Materials to obtain first: Protocol/SAP, results tables by scale and multiplicity/prespecified hierarchy documents.
Further research: Compare the prespecified hierarchy with all reported subscales, and separate analyses and interpretations by outcome.
Remaining uncertainty: Other favorable results do not substitute for a direct effect on the target IBD fatigue.
Conditions for verification: Distinguish the abstract's designation of fatigue(CIS) as primary from the exact subscale hierarchy, and do not repurpose separate motivation/depression/quality-of-life results.
Why this condition is needed: This is needed to prevent selection of a favorable subscale to replace the target subjective-fatigue result.
Application exceptions: Do not delete actual favorable reports for other endpoints because the target fatigue result was nonsignificant; retain their separate attribution.
Referenced methods: 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; separation of statuses is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application — an individual internal adaptation for endpoint hierarchy, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N17 · Have the actual randomized design, sequence and allocation concealment been verified?

Current findings: evidence records the original abstract of a randomized placebo-controlled trial. The KO assessment retains both the reports of randomization and double blinding and the unverified sequence and allocation concealment.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The design designation is preserved, but materials on the actual sequence, concealment and baseline balance are unavailable.
Reason for missing information: Sequence generation, concealment, baseline balance and the exact unit of analysis are unverified.
Required materials and conditions: Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance. Materials needed: original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table.
Materials to obtain first: Original Methods, allocation/concealment procedures, baseline characteristics and analysis-unit table.
Further research: Compare existing allocation documents and the baseline table, and apply only assessment questions appropriate to the design.
Remaining uncertainty: This gap alone does not establish the presence, absence or magnitude of bias.
Conditions for verification: Verify separately the reported randomized placebo-controlled design and actual sequence generation, allocation concealment and baseline balance.
Why this condition is needed: This is needed to avoid concluding from the RCT label that allocation-related bias or baseline differences have been resolved.
Application exceptions: Do not arbitrarily mark crossover/cluster considerations as inapplicable or reclassify the study as nonrandomized because design details are unavailable.
Referenced methods: M08 §8.1–8.2.3; internal application; M03 §3.2.1; detailed population criteria are internally designed — an individual internal adaptation for allocation and design, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03

N18 · Have blinding, the scale and collection conditions for fatigue measurement been verified?

Current findings: Randomization, double blinding and use of the CIS fatigue subscale are reported. Physical placebo composition, trial language/version and actual assessment procedures are unverified.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: A design and measure are named, but verification of identical measurement across arms and maintained blinding remains outstanding.
Reason for missing information: Participant/assessor-specific blinding, questionnaire collection conditions and missing measurements by arm are unverified.
Required materials and conditions: Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint. Materials needed: questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks.
Materials to obtain first: Questionnaire collection procedures, participant/assessor blinding and placebo matching/blinding checks.
Further research: Compare questionnaire/visit conditions and actual blinding to review measurement limitations by endpoint.
Remaining uncertainty: The fact that an endpoint is subjective does not itself mean the results are invalid or bias is established.
Conditions for verification: Verify participant/assessor blinding, questionnaire collection and between-arm measurement differences as appropriate to the subjective-fatigue endpoint.
Why this condition is needed: This is needed to distinguish differences in measurement of subjective outcomes from actual outcome differences.
Application exceptions: Do not treat the double-blind designation as confirmation of fully maintained blinding, or conclude failure solely because details are unverified.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.1–8.2.3; internal application — an individual internal adaptation for subjective measurement, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S06 S07

N19 · Can arm-specific and IBD-stratum analysis denominators also be verified beyond the total of 95 participants?

Current findings: reported_included_total is 95 participants. randomized_by_arm, analysed_by_arm, completed_by_arm, dropout_by_arm and IBD_only are all preserved as [null,null].
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The mixed-cohort total included is verified, but the target arm-specific analysis denominators are unknown.
Reason for missing information: Arm-specific randomized, completed, analyzed and dropout counts and IBD-stratum denominators remain outstanding.
Required materials and conditions: Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators. Materials needed: CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition.
Materials to obtain first: CONSORT flow diagram and tables of arm-specific randomized/completed/analyzed counts and IBS/IBD composition.
Further research: Link participant flow to denominators in each results table to review differences among randomized, completed and analyzed populations.
Remaining uncertainty: Do not use the total of 95 participants to create an effect SE, CI, event rate or unique IBD participant count.
Conditions for verification: Link the total included separately from arm-specific randomized/completed/analyzed counts and IBD-stratum denominators.
Why this condition is needed: This is needed to avoid dividing the mixed-cohort total in half or assuming that all were analyzed participants with IBD.
Application exceptions: When denominators are unavailable, do not estimate arm-specific counts; preserve only the descriptive total.
Referenced methods: 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 — an individual internal adaptation for allocation and analysis denominators, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03

N20 · Can ITT/PP, imputation and handling of attrition be verified?

Current findings: ITT_PP, imputation, rescue, adjustment_covariates and model are null. The KO assessment also retains arm-specific denominators, ITT/PP and imputation as unverified.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The actual analysis population cannot be linked to information on handling missing data/attrition.
Reason for missing information: Dropout reasons, analysis inclusion principles, imputation, adjustment/rescue handling and baseline fatigue values remain outstanding.
Required materials and conditions: Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results. Materials needed: arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment.
Materials to obtain first: Arm-specific dropout reasons, missing-data table, ITT/PP definitions, imputation/SAP and handling of rescue treatment.
Further research: Compare the original participant flow and analysis definitions, and plan a missing-data sensitivity review within the scope of acquired materials.
Remaining uncertainty: Without this information, no new between-group analysis or effect of assignment is reconstructed.
Conditions for verification: Compare reasons for missing data/dropout, ITT/PP, imputation and rescue treatment with the effect of interest in the analysis results.
Why this condition is needed: This is needed to prevent missing denominators from being converted into complete follow-up or an ITT analysis.
Application exceptions: Unverified baseline/analysis details do not mean that there was no attrition in either arm or that bias is established.
Referenced methods: 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; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for missing data and analysis population, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N21 · Can mixed-cohort change values, the definition of ± and the type of values be verified?

Current findings: Mixed-cohort changes are recorded as B12 −8.1 ±9.5 and placebo −8.3 ±10.6. plus_minus_type and mean_or_median_label are null. These values were not used as the IBD-stratum effect.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The reported original values are preserved, but the statistical definitions of the values and ± are unverified.
Reason for missing information: Mean/median, whether ± denotes SD/SE, baseline/end values and denominators are unverified.
Required materials and conditions: Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE. Materials needed: original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators.
Materials to obtain first: Original results table, definition of ±, mean/median, baseline/end/change values and arm-specific denominators.
Further research: Compare numerical column headings, dispersion notation and denominators in the table to verify the type of values. Do not newly calculate statistics without authorization.
Remaining uncertainty: Similar directions do not provide grounds for calculating an effect of 0 or equivalence.
Conditions for verification: Preserve the mixed IBS/IBD change values of −8.1 ±9.5 and −8.3 ±10.6 in their original units, without inferring mean/median or SD/SE.
Why this condition is needed: This is needed to prevent the displayed ± from being assumed to be SD and used to create precision or a target IBD effect.
Application exceptions: Retain the original values as the corresponding mixed-cohort changes without deleting them. Do not convert them into absolute baseline/end values or a between-group estimate.
Referenced methods: 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; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for original mixed-cohort values, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S16

N22 · Has the existing +0.2-point value been kept from being converted into the target IBD effect?

Current findings: The manuscript and assessment_profile.calculation preserve +0.2 CIS points as a simple mixed-cohort difference. status is descriptive_mixed_cohort_arithmetic_only; n, SD, SE, df and the interval are null, and it is explicitly not a target-population estimator. The calculation was not executed in this run.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The population and limitations of the existing descriptive arithmetic were stated, without elevating it to an IBD effect or a new statistical result.
Reason for missing information: The target IBD estimand is unavailable, and the original arithmetic tools/audit were not checked for reproducibility in this run.
Required materials and conditions: Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI. Materials needed: original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators.
Materials to obtain first: Original results table, existing arithmetic record and analysis document specifying the estimand/population/denominators.
Further research: In an authorized subsequent review, compare original values with calculation definitions, and keep the descriptive difference and target estimand in separate columns.
Remaining uncertainty: The descriptive difference and the authors' estimated adjusted between-group effect cannot be assumed to be the same value.
Conditions for verification: Preserve the manuscript's simple mixed-cohort difference of +0.2 as existing descriptive arithmetic, and distinguish it from the actual adjusted between-group effect and CI.
Why this condition is needed: This is needed to prevent earlier descriptive calculations from being presented as a new calculation in this run or a directly eligible estimate.
Application exceptions: The calculation audit/tools are not executed or separately read in this run. Preserving the original arithmetic value alone does not constitute a claim of reproducibility verification.
Referenced methods: 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for the historical descriptive difference, not implementation of or certification by an official assessment tool.

Related sources S01 S17

N23 · Has the estimate corresponding to the 95% CI −11.65~6.71 been verified?

Current findings: The manuscript records 95% CI −11.65~6.71, but unassigned_CI_estimand is null. target_CI is also null, and this CI was not attached to the simple mixed-cohort difference of +0.2.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: CI values are present, but the corresponding estimand/analysis/population is unverified, so they cannot be used to judge target precision.
Reason for missing information: The corresponding estimate, target stratum, denominators, dispersion/model and exact original context of the CI remain outstanding.
Required materials and conditions: Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis. Materials needed: CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators.
Materials to obtain first: CI headings in the original Results/tables, corresponding estimate, group/stratum, model and denominators.
Further research: Compare the original CI sentence and table to verify which estimand the interval concerns, then interpret it in the same units and at the same time point.
Remaining uncertainty: The presence of numbers differs from having acquired the target CI; a mismatch with the simple difference is not immediately designated as Conflicting information.
Conditions for verification: Attach a reported CI to an effect only after verifying its population, estimate, denominators and analysis.
Why this condition is needed: This is needed to prevent an unattributed CI from being attached as the interval for the existing +0.2 or the IBD-stratum effect.
Application exceptions: Preserve both the original notation and the unverified attribution, without deleting the CI or calculating a new interval.
Referenced methods: 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; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed — an individual internal adaptation for CI attribution, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S03 S16

N24 · Have the IBD-stratum difference in change, CI and P and their relationship to importance been verified?

Current findings: target_between_group_estimate, target_CI and target_P are null. pooled_exact_P, the model and adjustment covariates are also unverified, and the IBD between-group MCID is null as well. Preserve the original target_estimate=null and 0 directly eligible results unchanged.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Without the target result and interval, importance and precision cannot be compared.
Reason for missing information: The IBD-stratum effect/CI/P, denominators, dispersion, analysis definition and target MCID remain outstanding.
Required materials and conditions: Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance. Materials needed: adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence.
Materials to obtain first: Adjusted/unadjusted IBD-stratum difference in change, CI/P, model, denominators and target MCID evidence.
Further research: First fix the target estimand and compare the results table with the analysis plan; review importance/precision only against verified criteria.
Remaining uncertainty: Unverified data do not constitute a judgment of efficacy/inefficacy, equivalence or the probability of an effect.
Conditions for verification: Link the target IBD stratum's between-group estimate, denominators, CI, P and model, and compare them with applicable evidence of importance.
Why this condition is needed: This is needed to prevent effect size or sufficiency from being inferred solely from total sample size, nonsignificance or an unattributed CI.
Application exceptions: Do not adopt sample-size/duration thresholds or a new grade while the MCID, model and target values remain unverified.
Referenced methods: 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 — an individual internal adaptation for target effect and precision, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04 S05

N25 · Have the candidate registration's actual identity and comparison of the plan with results been verified?

Current findings: S04 is a provisional linkage to NL-OMON34980, and the citation records registry_search_snippet_only. Direct record/PDF access failed at that time. The original trial full text, protocol, SAP and prespecified subscale and time-point hierarchy are unverified in the current input.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: A candidate registration exists, but there is no evidence that the actual plan was read and compared with the report.
Reason for missing information: Confirmed registry linkage, version history and comparison of planning documents with results remain outstanding.
Required materials and conditions: Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan. Materials needed: original official registry record/version, protocol/SAP and reported results/reasons for changes.
Materials to obtain first: Original official registry record/version, protocol/SAP and reported results/reasons for changes.
Further research: Verify dates/versions of existing registration and plans, and compare the original report's subscales, time points and analyses individually.
Remaining uncertainty: Failure to acquire materials does not establish nonregistration or selective reporting, and access was not retried in this run.
Conditions for verification: Record whether the NL-OMON34980 linkage is confirmed and the actual scope of comparison of the protocol/SAP, subscales/time points and analysis plan.
Why this condition is needed: This is needed to avoid claiming that a prior plan is verified solely from a registry search lead, or establishing nonregistration from an access failure.
Application exceptions: Do not repurpose the S04 tablet lead or past access failure as the actual formulation or a current access failure.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for registration and plan, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S04

N26 · Has mixed-cohort nonsignificance been kept from being converted into an IBD effect of 0 or equivalence?

Current findings: The original authors reported no significant between-group difference in subjective fatigue in the mixed cohort. This contrary, nonsignificant result is preserved, but the exact pooled P and IBD-stratum results are unverified. Nonsignificance was not interpreted as an IBD effect of 0 or equivalence.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The verified contrary report and interpretive limitations were retained together, without newly assessing the target effect.
Reason for missing information: The exact test, target interval, equivalence margins and target-stratum estimate are unavailable.
Required materials and conditions: Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design. Materials needed: original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis.
Materials to obtain first: Original Results, exact P, interval, test/equivalence margins and IBD-stratum analysis.
Further research: Compare the direction, population and estimand across all relevant results, and examine equivalence questions using a separate design with prespecified margins.
Remaining uncertainty: Statistical nonsignificance and absence of effect/equivalence are different claims.
Conditions for verification: Retain the report of nonsignificant subjective fatigue in the mixed cohort, while linking limitations concerning the population, exact P/interval and equivalence design.
Why this condition is needed: This is needed to avoid hiding contrary results or establishing no effect solely from nonsignificance.
Application exceptions: Do not convert nonsignificant subjective fatigue into absence of a separate motivation result.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application — an individual internal adaptation for nonsignificant results, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S16

N27 · Can independent replication results for the target IBD fatigue be verified?

Current findings: The original count of directly eligible results is 0, and existence of human research is true. The KO assessment records replication as unevaluated because eligible results are unavailable. Articles, registration leads and reviews are not independent replications, and the replication axis is null.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The retained scope lacks a target result set, so independent replication/heterogeneity cannot be compared.
Reason for missing information: The distribution of directly eligible IBD results by family, confirmed independent identities and the total of unique participants remain outstanding.
Required materials and conditions: Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants. Materials needed: eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis.
Materials to obtain first: Eligible IBD comparative results, unique trial/registration family table and distribution of results by time point/analysis.
Further research: First compare direct eligibility and family identity, and compare differences in conditions/contrary results only when a new independent result is available.
Remaining uncertainty: Here, 0 is the count of verified eligible results, not a worldwide trial count of 0.
Conditions for verification: Distinguish the verified scope of directly eligible results, related families and requotations, without estimating replication or unique participants.
Why this condition is needed: This is needed to prevent 17 materials or multiple reports of a single trial from being converted into independent replication.
Application exceptions: Do not convert the absence of verified eligible results into absence of heterogeneity across all studies or Not applicable for applicability across conditions.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for eligible replication, not implementation of or certification by an official assessment tool.

Related sources S01 S02 S04 S05 S08 S16

N28 · Have the favorable combination-product results in S09 been separated from the effect of B12 alone?

Current findings: The manuscript preserves favorable results from another trial of a B-vitamin and magnesium combination, but does not repurpose them as a fatigue effect of B12 alone. The S09 citation contains only historical verification locations for Abstract, Methods and fatigue results; detailed result values/denominators are absent from this stored summary.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Favorable results were retained while explicitly marking the boundary between the combination product and the target single-ingredient question.
Reason for missing information: S09 composition, population, scale, effect estimates, denominators and the contribution of B12 alone were not retained in detail.
Required materials and conditions: Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone. Materials needed: S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents.
Materials to obtain first: S09 actual composition, route, population, fatigue scale, arm-specific results/denominators and design documents.
Further research: Compare original combination-product reports by ingredient/population/scale, and consider comparisons separating ingredients when an individual contribution is the question.
Remaining uncertainty: Favorable results for a different composition/question do not automatically constitute Conflicting information with the contrary report for the target question.
Conditions for verification: Retain the favorable fatigue results for the B-vitamin and magnesium combination in their original report context, without repurposing them as the contribution of B12 alone.
Why this condition is needed: This is needed to prevent results from a trial containing other active ingredients from being attributed to single-ingredient efficacy.
Application exceptions: Do not delete favorable indirect results either. Do not fill in doses, denominators or effect estimates absent from the current stored summary by estimation.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application — an individual internal adaptation for the combination-product boundary, not implementation of or certification by an official assessment tool.

Related sources S09

N29 · Can the original-trial linkages and target IBD results in S05/S08 be verified?

Current findings: S05 records the exclusion of Scholten2018 because IBS/IBD results were not separated. S08 is a citation containing a historical verification location in a transcription of a systematic review of cognition, depression and fatigue; detailed results/included-trial materials were not separately retained in this stored summary.
Verification status: Partly verified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The S05 exclusion reason is linked to the manuscript, but S08 target eligibility and study-specific results cannot be judged from location records alone.
Reason for missing information: Actual details of the S08 original review/included trials and whether they address the target oral single-agent IBD comparison remain outstanding.
Required materials and conditions: Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary. Materials needed: review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results.
Materials to obtain first: Review inclusion/exclusion tables, original-trial linkages and each study's population/intervention/endpoint/results.
Further research: Compare the linkage table between reviews and original reports to group the same trials/requotations, and separately verify only eligible comparisons.
Remaining uncertainty: Do not add reviews to their included studies, or describe details not retained as unreported throughout the article.
Conditions for verification: Link review inclusion/exclusion and requotation identities to the actual original trials, and distinguish the scope of results retained in the current stored summary.
Why this condition is needed: This is needed to prevent the number of review documents from being converted into a count of new independent effect replications.
Application exceptions: Do not create new results or a unique trial count solely from the S08 location record of Section3.6, Table1 Schlichtiger1996 and reference81.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application — an individual internal adaptation for reviews and requotations, not implementation of or certification by an official assessment tool.

Related sources S05 S08

N30 · Have intranasal ME/CFS, sublingual fibromyalgia and protocol materials been separated?

Current findings: The manuscript explicitly distinguishes intranasal administration in ME/CFS and sublingual before-and-after observations in fibromyalgia from this claim. S12 is a protocol search citation, and direct full-text access failed at that time. Detailed response values from original materials and S12 completed results were not newly filled in during this run.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The scope of documents concerning other populations, routes, before-and-after observations and plans was separated from the target oral IBD between-group results.
Reason for missing information: Detailed S10/S11 results and the actual S12 plan/completion status were not directly compared in this run.
Required materials and conditions: Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results. Materials needed: S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report.
Materials to obtain first: S10/S11 actual populations, administration/analysis and results, and the S12 original protocol and subsequent completed report.
Further research: Distinguish population, route, controlled/before-and-after comparison and plan/results for each report in an identity table, and review the eligible IBD question separately.
Remaining uncertainty: This boundary record is not a new assessment of effects in other diseases.
Conditions for verification: Distinguish the different populations, routes and before-and-after observations in S10/S11 and the S12 protocol search identity from the target comparative results.
Why this condition is needed: This is needed to prevent response observations in other diseases and routes or planning documents from being converted into completed oral IBD RCT results.
Application exceptions: Do not establish the population, product or completed results solely from the S12 search citation. Do not fill in responder counts absent from the current stored summary.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; 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 — an individual internal adaptation for other fatigue studies, not implementation of or certification by an official assessment tool.

Related sources S10 S11 S12

N31 · Have serum increases, anemia recovery and vitality been kept from replacing CIS fatigue?

Current findings: The manuscript does not use a role in energy metabolism, increased serum B12, correction of anemia or experiences of vitality as substitute evidence for a CIS fatigue effect versus placebo. The patient-reported symptom score in this table is not extended to hospitalization, complications, death or Hb recovery.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The boundary between the selected endpoint and other questions was preserved, without creating unverified results for other events.
Reason for missing information: Direct comparative evidence for extended questions is outside the scope of this review.
Required materials and conditions: Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score. Materials needed: endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question.
Materials to obtain first: Endpoint-specific definitions/original results and direct comparative materials for the proposed extended clinical question.
Further research: Separate current fatigue results from other endpoints, and first define a distinct population, comparator and time frame if an event/anemia/vitality question is requested.
Remaining uncertainty: The symptom score is a patient-reported outcome and is not automatically converted into a biochemical surrogate or hard clinical event.
Conditions for verification: Distinguish mechanisms, serum B12, Hb/anemia and vitality/other clinical events from the target patient-reported fatigue score.
Why this condition is needed: This is needed to prevent a metabolic role or correction of anemia from being converted into direct benefit for the target fatigue versus placebo.
Application exceptions: Do not require all event trials for the selected symptom-score question; review them separately when a claim is extended.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internally defined boundaries on extension; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed — an individual internal adaptation for mechanisms and clinical extension, not implementation of or certification by an official assessment tool.

Related sources S01 S10 S11 S17

N32 · Has the actual scope of disclosures for funding, product supply and COI been verified?

Current findings: Funding sources and product supply are unverified in the manuscript. funding, product_supply, employee_authors and patents are null, and the record states that a publisher-index lead was not treated as a complete COI disclosure.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Without the actual original disclosures, independence or the level of funding cannot be established.
Reason for missing information: Complete Funding/COI, product supply, employment/patents and institutional relationships remain outstanding.
Required materials and conditions: State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI. Materials needed: original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures.
Materials to obtain first: Original Funding/COI, product supply, author employment/patents and institutional/trial-family disclosures.
Further research: Compare original disclosures with product supply and institutional relationships, record only the verified level, and separate this from replication-family identity.
Remaining uncertainty: Unverified information is neither proof of absent funding or independence nor grounds for invalidating results.
Conditions for verification: State the actual scope of disclosures and unverified information on funding, product supply, employment/patents and COI.
Why this condition is needed: This is needed to prevent unverified funding from being converted into independent funding or proof of independent replication.
Application exceptions: Do not automatically exclude results because a COI lead exists, or conclude absence of bias because none is available.
Referenced methods: Chamgap's internal independence and attribution criteria. The official methods sections used in this pilot do not endorse every detail of this item; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is an internal application — an individual internal adaptation for funding and interests, not implementation of or certification by an official assessment tool.

Related sources S01 S03 S16

N33 · Have arm-specific adverse events, serious adverse events, discontinuations and denominators in the oral trial been verified?

Current findings: actual_trial_fields.safety records 8 weeks and leaves events_by_arm, SAE_by_arm and AE_discontinuations_by_arm all as [null,null]. status explicitly states that these were not reported/unverified in the original abstract, not 0.
Verification status: Unverified
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Within the retained original-abstract content read, arm-specific harm and discontinuation counts and denominators cannot be verified.
Reason for missing information: Event/person counts, AE/SAE, discontinuations, exposure denominators, collection methods and losses to follow-up are unverified.
Required materials and conditions: Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up. Materials needed: arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up.
Materials to obtain first: Arm-specific AE/SAE/discontinuation tables, person/event counts, exposure denominators, collection methods and losses to follow-up.
Further research: Compare original safety collection with events/persons and denominators, and prespecify systematic collection, discontinuation reasons and losses to follow-up in future comparisons.
Remaining uncertainty: Do not newly calculate or assert 0 events, risk ratios, incidence or long-term safety.
Conditions for verification: Verify separately the oral trial's arm-specific AE/SAE/discontinuations due to adverse events, denominators and collection/follow-up.
Why this condition is needed: This is needed to avoid establishing absence of events or safety simply because safety events are absent from an efficacy summary.
Application exceptions: Do not extend what could not be verified in the original abstract to nonreporting throughout the full article. Do not delete original efficacy values because of gaps in harms information.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed — an individual internal adaptation for trial harms and denominators, not implementation of or certification by an official assessment tool.

Related sources S01 S03

N34 · Has the absence of an established UL for B12 been kept from being converted into an unlimited safety guarantee?

Current findings: The original safety statement explicitly says that the absence of an established UL is not an unlimited safety guarantee. S13 retains historical full-text HTML verification locations for Health Risks, Medication interactions and B12 status assessment, but was not directly read in this run.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The interpretive scope of the absent UL and official documents/trial results were separated. Gaps in direct harms evidence were not erased.
Reason for missing information: There was no direct comparison of current official-document content, interaction-specific details or target-trial harms data.
Required materials and conditions: Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data. Materials needed: the relevant S13 safety/status/medication sections and direct harms data by exposure and population.
Materials to obtain first: The relevant S13 safety/status/medication sections and direct harms data by exposure and population.
Further research: Compare the scope of judgments in official documents with the direct trial's population, duration and collection methods; consider suitable separate designs for rare and long-term harms.
Remaining uncertainty: Official information is not treated as providing incidence for the trial preparation whose chemical form is unverified.
Conditions for verification: Distinguish the scope of official B12 safety/status and medication documents from direct trial harms data.
Why this condition is needed: This is needed to prevent water solubility or the absence of a UL from being converted into safety evidence for a particular high oral dose, population or duration.
Application exceptions: An official-document link or historical reading record does not constitute access to the official original in this run or verification of the trial's event rate.
Referenced methods: M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for UL and general safety, not implementation of or certification by an official assessment tool.

Related sources S13

N35 · Have the chemical forms covered by the cobalt-sensitivity notice been preserved?

Current findings: The manuscript links the cobalt-sensitivity notice to hydroxocobalamin and cyanocobalamin. S14 cites the corresponding official drug-safety-update HTML and was not repurposed as incidence in this oral trial with an unverified chemical form.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The official notice's chemical-form boundary and the unverified target preparation were preserved together.
Reason for missing information: The actual trial chemical form and cobalt-allergy eligibility/events were not compared with the current full notice.
Required materials and conditions: Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified. Materials needed: preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data.
Materials to obtain first: Preparations/exposures covered by the S14 official notice, the actual trial chemical form and allergy eligibility/event data.
Further research: Compare preparations and exposures in the notice with the trial product to review applicability, and separate allergy/alternative explanations in the harms record.
Remaining uncertainty: The existence of a warning is not a judgment of risk magnitude for the target exposure or of individual safety.
Conditions for verification: Distinguish the official notice concerning hydroxocobalamin and cyanocobalamin from the oral trial whose actual chemical form is unverified.
Why this condition is needed: This is needed to prevent a warning for a particular chemical form from being converted into confirmed events or incidence in this trial.
Application exceptions: Do not interpret an unverified chemical form as meaning there is no cobalt sensitivity.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for cobalt and chemical form, not implementation of or certification by an official assessment tool.

Related sources S14

N36 · Have the injectable product's Leber and hypokalemia warnings been separated from oral incidence?

Current findings: Leber optic neuropathy and hypokalemia early in intensive treatment of severe megaloblastic anemia are recorded in the context of the cyanocobalamin injection label accessed for the manuscript. They were not transferred to event rates in the oral trial whose chemical form is unverified.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The warnings' route and treatment context were retained and separated from direct harms observations in the target trial.
Reason for missing information: A current recomparison of the full label and direct event data for the relevant oral exposure are unavailable.
Required materials and conditions: Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms. Materials needed: S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data.
Materials to obtain first: S15 label Contraindications/Warnings, the context of testing early in treatment and actual oral-preparation/harms data.
Further research: Compare the official label's route, disease and treatment phase with the target exposure to distinguish the scope of harms warnings.
Remaining uncertainty: The limitation arising from a different route does not discard injection warnings or establish that oral administration is risk-free.
Conditions for verification: Preserve the disease, treatment phase and route in the cyanocobalamin injection label as in the manuscript, without repurposing them as oral-trial harms.
Why this condition is needed: This is needed to prevent warnings in the context of injections and intensive anemia treatment from being converted into causality/frequency for another oral exposure.
Application exceptions: Do not delete the warnings or add incidence or individual dosing instructions.
Referenced methods: M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an individual internal adaptation for the injection-label boundary, not implementation of or certification by an official assessment tool.

Related sources S15

N37 · Are long-term, vulnerable-group and optimal-dose data required for this 8-week fatigue question?

Current findings: The current unit is the reported 8-week CIS fatigue comparison in a restricted adult population. The manuscript does not generalize 8 weeks to the safety of long-term high doses or use in pregnancy/lactation, children or liver/kidney disease, and does not use the study dose as an instruction for individual dosing or treatment changes.
Verification status: Does not apply
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: This is an applicability exception: long-term/special-population/optimal-dose trials are not imposed as required conditions for the narrow symptom question. It does not indicate that evidence for those extensions has been verified.
Reason for missing information: Direct materials for extended questions outside the current assessment target are unverified.
Required materials and conditions: Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope. Materials needed: data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials.
Materials to obtain first: Data on the population/duration/direct dose/follow-up after discontinuation proposed for extension, systematic harms data and separate clinical-question materials.
Further research: Define a separate population, exposure and follow-up/comparison only when an extended question is requested, and consider suitable observational/comparative designs for rare/long-term harms.
Remaining uncertainty: Does not apply is not a substitute label for external materials not read. The direct safety gap remains in N33.
Conditions for verification: Distinguish questions about long-term/rare harms, pregnancy/lactation/children, liver/kidney disease, optimal dose and individual management from the current scope.
Why this condition is needed: This is a supplementary boundary to prevent short-term reports in a restricted population from being converted into overall safety and dosing recommendations.
Application exceptions: Do not require every long-term/vulnerable-group/dose study for the reported 8-week fatigue question.
Referenced methods: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are internally designed; M19 §19.1.2–19.2.4; internal application; Chamgap's internal interpretive boundaries. M19 principles are referenced; no official causality tool is implemented — an individual internal adaptation for extension to longer durations and vulnerable groups, not implementation of or certification by an official assessment tool.

Related sources S01 S13 S14 S15

N38 · Have 0 directly eligible results, the existence of human research, ?/null and the legacy gate been separated?

Current findings: The original grade is ? and score is null. no_human_study=false, existence of human research=true, directly eligible results are 0, and downstream axes are null. The manuscript records disclosure of the legacy calculator's diagnostics for the original factual profile and a separate nonempirical gate projection. Neither the history nor the conceptual symptom P was transferred into a score/grade for the new table.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: The separation of the original assessment from factual/compatibility records was preserved. The calculator/audit was not rerun and the grade was not validated in this run.
Reason for missing information: The sealed audit's original diagnostics and execution bytes were not directly checked in this run.
Required materials and conditions: Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score. Materials needed: the current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record.
Materials to obtain first: The current original assessment, original scoring inputs/diagnostics, separate gate projection and existing calculation record.
Further research: When an authorized correction is needed, separate the factual profile, compatibility mapping and calculation event, and preserve before/after values and reasons. No reassessment is performed in this run.
Remaining uncertainty: The original ? is the original assessment symbol, not a material-verification status in the table or a probability of effect.
Conditions for verification: Preserve unchanged the original grade/score, factual profile, null downstream axes and record of the legacy nonempirical gate projection, without generating a new status or score.
Why this condition is needed: This is needed to prevent unverified direct eligibility from being converted into no_human_study=true, or document quality/historical calculations from being inherited as an efficacy score.
Application exceptions: The S17 sealed audit and calculator are not read or executed in this run. Do not fill a null scoring axis with the conceptual symptom P.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design — an individual internal adaptation for original assessment and calculation history, not implementation of or certification by an official assessment tool.

Related sources S17

N39 · Have original ID/URL, document quality and deployment metadata been distinguished from completion of the current table?

Current findings: Link the 3114 ID and current canonical. Original document A and single-assistant self-review are separate from efficacy ?. The original stored summary retains needs_id_assignment alongside assigned, and initial unpublished/first_published_at=null alongside server_deployed=true and deployed_at=2026-09-16. These were not elevated to actual publication of the current table, and original values were not corrected.
Verification status: Met
Materials actually read: The retained stored summary was read; access to external original sources/the separate audit was not attempted, and they were not acquired or read in this run
Why unverified: Different labels in the original metadata were preserved, and current stored-summary production, QA by another author, derived formats, UI and publication were marked as separate stages.
Reason for missing information: Actual publication/identity records for each event in the original metadata were not directly compared in this run.
Required materials and conditions: Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events. Materials needed: original identity/operational metadata, actual publication records and revision triggers/original-version preservation records.
Materials to obtain first: Original identity/operational metadata, actual publication records and revision triggers/original-version preservation records.
Further research: When operational facts are updated, compare actual records with original metadata, and distinguish criterion revisions, evidence additions and output/publication events.
Remaining uncertainty: Original operational labels are not evidence of a clinical conclusion or completed website deployment in this run.
Conditions for verification: Preserve the current canonical/ID and historical operational metadata, and separately record actual completion of content/format/UI/publication and update events.
Why this condition is needed: This is needed to prevent document A, past self-review and deployment labels from being converted into clinical certification or completed publication of the current table.
Application exceptions: Do not silently reconcile semantic_code_status and assigned labels, or server_deployed and initial unpublished/null time records, even when they coexist.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limitations on the current material conversion reflect user-defined scope and internal design; M04 §4.5–4.6 principles for collecting/selecting materials; separation of access and reading and the hyperlink contract are internally designed — an individual internal adaptation for operational metadata and updates, not implementation of or certification by an official assessment tool.

Related sources S17