Added riboflavin (vitamin B2) × Hemoglobin increase in anemic pregnant women receiving iron and folate

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 · One question about an added treatmentIs the single question in this table IFB versus IF, with only B2 added to the same iron and folate?Required	The original effect field (/ko/effect) and the definition of the question being judged fix the outcome as an increase in Hb in anemic pregnant women receiving iron and folate. The principal comparison is Ma’s IFB versus IF, distinguished from the IFAB combination arm and from anemia treatments as a whole. S23	The definition of the single original principal comparison (main) and its exclusion boundaries were verified in the currently preserved manuscript. This is separate from verifying the magnitude of the Hb effect.	Corrections to the definition of the current claim being judged, population, IFB/IF components, endpoint, and timeframe, or new original source material.	Compare the components of each arm against the question-definition table and review the selection decisions that exclude vitamin A add-on arms and the anemia-prevalence question.
2	Partly verified	Full text not readStored summary read	N02 · Selection of anemic pregnant womenHave the Hb eligibility criteria, stage of pregnancy, and baseline characteristics of the anemic pregnant women been verified?Required	The population consists of pregnant women selected for anemia by Hb. The current manuscript does not provide the Hb threshold, gestational age, detailed inclusion/exclusion criteria, or the complete baseline characteristics by arm as verified information. S23	The population has been identified as pregnant women with anemia, but material is still needed to verify the detailed selection criteria and baseline distributions.	Ma’s Hb eligibility threshold, gestational age, recruitment/exclusion criteria, and baseline-characteristics table by arm.	Compare the original eligibility criteria with the flow diagram and baseline table to extract the Hb definition and stage of pregnancy, and review limitations on applicability to other maternal populations.
3	Unverified	Full text not readStored summary read	N03 · Causes of anemiaHave the causes of anemia and the presence or absence of iron deficiency in IFB/IF participants been classified?Required	A complete classification of the causes of Hb-defined anemia remains unverified. Do not classify all participants as having iron-deficiency anemia or generalize the findings to treatment effects for all anemia. S23	Hb-based selection alone does not verify diagnoses by cause or the presence or absence of iron deficiency.	Diagnostic methods for each cause of anemia, iron-status indicators, the composition of the IFB/IF arms by cause, and separate results by cause.	Distinguish Hb-based selection from a diagnosis of iron deficiency, review the classification of causes, and check whether the results by cause come from planned comparisons.
4	Unverified	Full text not readStored summary read	N04 · Baseline B2 statusHave baseline B2 status and the method for identifying deficiency in Ma’s participants been verified?Required	The full details of baseline vitamin status and the method for identifying deficiency in the principal eligible population are blank/unverified. Do not transfer the eligibility criteria for RIBOFEM’s healthy women with low B2 status to Ma’s pregnant women. S23 S10	No material is available to verify the presence or absence of B2 deficiency or its distribution in this population of pregnant women.	Ma’s methods for measuring baseline vitamin status, deficiency thresholds, distributions by arm, and prespecified analysis plan.	Extract the assessment of B2 status separately from Hb-based selection, and review whether there is a planned between-group comparison within the deficient stratum.
5	Partly verified	Full text not readStored summary read	N05 · Molecule and formulationHave the molecule, product, and detailed formulation of the B2 preparation actually used been verified?Required	The molecule riboflavin is verified. The detailed formulation, release profile, and production origin, such as synthesis or fermentation, remain unverified in the decisive abstract. Plant-part classification does not apply to this question about a molecule. S23	The molecule has been verified, but the detailed formulation cannot be filled in as a verified value.	Information on the composition/product, detailed formulation, release profile, and manufacture of Ma’s trial preparation.	Compare trial-preparation records to extract the identity of riboflavin, the product, and the release profile, and exclude results for other B-vitamin types or formulations.
6	Unverified	Full text not readStored summary read	N06 · Actual route of administrationIs the actual route of administration in Ma’s IFB/IF arms explicitly stated?Required	The verdict concerns a question about oral supplementation. Ma’s abstract does not specify the route of administration or detailed formulation, so the route value in the preserved study information (route.value) is blank/not_reported. S23	The route specified in the question is fixed, but the actual route is not reported in the accessed decisive abstract, and the full text was not read in this work either.	Methods material explicitly stating Ma’s actual route of administration and formulation.	Compare the oral-route token (oral) in the question being judged with the actual route in the trial methods as separate records, and update the verification status of the observed route.
7	Met	Full text not readStored summary read	N07 · Added B2 doseIs the nominal added B2 dose in the principal comparison 1.0 mg/day?Required	The dose value in the preserved study information (dose.value) and the supplementation-dose value (supplement_dose.value) are 1.0. The principal comparison adds B2 1.0 mg/day; Suprapto’s 5 mg is not pooled with it. S23	The nominal added dose in the principal comparison was verified in the original data structure, without extending its meaning to the dose actually taken.	Corrections to Ma’s supplementation doses by arm, or records of actual administration.	Verify the prescribed dose in each arm, and do not add the 5 mg from another study or total dietary intake to this nominal added dose.
8	Met	Full text not readStored summary read	N08 · Shared iron and folateHave the shared iron and folate in IFB and IF, and the excluded combination arms, been fixed?Required	The comparator receives the same iron 60 mg/day and folic acid 400 μg/day. Select IFB versus IF, with only B2 added to shared iron and folate, and exclude arms that also add vitamin A. S23	The nominal shared treatment and the definition of the comparison in terms of added components were verified in the original treatment descriptors (facets) and manuscript. Actual adherence remains separately unverified.	Corrections to the shared treatment in IFB/IF, records of actual concomitant treatment/changes, and information on arm composition.	Compare the component tables for the four arms, and review the extent to which the shared treatment was maintained and B2 was the only difference.
9	Met	Full text not readStored summary read	N09 · Duration of the principal comparisonIs supplementation in the principal IFB/IF question given for 2 months?Required	The duration of the principal question is verified as a duration value (amount) of 2, measured in months (unit). Longer-term and postpartum persistence remain unverified, and the 60 days in another study are not automatically merged as the same analysis time point. S23 S24	The original data structure verifies the principal duration as 2 months, so the criterion for identifying that narrowly defined duration is met.	Corrections to the duration of Ma’s principal comparison, and the measurement schedule.	Compare the start and end of administration with the timing of Hb measurements to distinguish the nominal 2 months from the actual observation period.
10	Partly verified	Full text not readStored summary read	N10 · Allocation and blindingHave Ma’s random sequence, allocation concealment, and blinding procedures been verified?Required	Ma’s study is preserved as a randomized, double-blind, four-arm trial. The current summary does not contain details of sequence generation, allocation concealment, or blinded assessment, or complete information on baseline balance. S23	The design type was verified, but the detailed allocation and measurement procedures have not been verified.	Ma’s random sequence, allocation concealment and blinding methods, and baseline table by arm.	Compare the methods and baseline table of the four-arm trial to distinguish the stated design from actual procedures, and retain the areas that cannot be verified.
11	Unverified	Full text not readStored summary read	N11 · Adherence and changes in concomitant treatmentHave actual adherence, rescue treatment, and total exposure in IFB/IF been verified?Required	Shared iron and folate and the added B2 dose define the nominal comparison. Total dietary intake and exposure to all supplements are blank/unverified, and adherence and rescue-treatment information by arm could not be verified in the current summary either. S23	The nominal doses and shared treatment alone do not establish that actual exposure or changes by arm have been verified.	Records by arm of intake/adherence, rescue treatment, changes to iron/folate, diet, and other supplements.	Review changes in administration and concomitant treatment over time, and compare the scope of analyses of the effect of assignment with that of analyses of the effect of actual intake.
12	Partly verified	Full text not readStored summary read	N12 · Hb measurementHave the Hb measurement methods, units, time points, and assessment procedures in IFB/IF been verified?Required	The selected endpoint is the between-group difference in the change in blood Hb concentration. Anemia prevalence was also reported, but it does not replace this question. The actual Hb assay, measurement schedule, and complete assessment procedures remain unverified. S23	The endpoint's identity is linked, but the original methods and tables needed to verify the actual measurement conditions are still required.	Ma’s Hb assay methods, units, baseline/end-of-treatment measurement table, and information on blinded assessment.	Compare the Hb measurement procedures with the time points and units in the results tables, and keep them separate from anemia prevalence or other laboratory values.
13	Unverified	Full text not readStored summary read	N13 · Effect of interest and analysisHave the actual analysis population, adjustment, and definition of change for IFB versus IF been verified?Required	The question concerns the between-group difference in Hb change, but the corresponding IFB/IF effect size and dispersion remain unverified. Because complete paired-data or adjustment inputs were unavailable, the original record of effect-size attempts (effect_size_attempts) also produced no new approximation. The actual ITT/PP population or model is not filled in. S23	The actual analytical definition for the principal comparison has not been verified, so it cannot be replaced with assignment counts or arithmetic from another comparison.	The IFB/IF analysis plan, ITT/PP populations, adjustment model, definition of change, and original results tables.	Compare the reported analysis with the plan and review the scope of the estimate, without turning a within-group rise into a between-group effect of adding B2.
14	Partly verified	Full text not readStored summary read	N14 · Allocation and analysis denominatorsHave the 366 participants assigned overall and the 91/93 assigned to the two arms been linked to the actual Hb analysis denominators?Required	There were 366 participants assigned overall: IFB 91 and IF 93. The original descriptive total of 184 refers to assigned participants, not the endpoint analysis count (assigned_participants/not_analyzed_endpoint_n). The value field for the Hb analysis denominator is empty/unverified. S23	The assignment counts have been preserved, but they have not been linked to the corresponding Hb measurement and analysis counts (n) or to the flow of missing data.	Ma's IFB/IF participant flow diagram, measurement and analysis counts (n), reasons for exclusion, and table of missing-data handling.	Compare the total across the four arms with the participant flow in the two comparison arms, and check that the original total of 184 participants is not used as the analysis denominator.
15	Unverified	Full text not readStored summary read	N15 · Hb difference from adding B2 aloneHas the between-group Hb effect size for IFB versus IF been verified?Required	The IFB–IF Hb effect size and dispersion remain unverified in the currently accessible materials. EX denotes this verification limit; it does not mean an effect of 0 or that data are absent from the entire full text that could not be accessed. S23	The inputs needed to verify the effect value for the principal comparison of adding B2 alone are unavailable.	Ma's Hb values by IFB/IF arm, between-group estimate, definitions, and original tables.	Compare the original results tables for the four arms, extract only the estimate for the principal IFB/IF comparison, and exclude values for the combination arm or prevalence.
16	Unverified	Full text not readStored summary read	N16 · Dispersion and intervalsHave the type of dispersion measure, CI, and criterion for an important difference for IFB/IF been verified?Required	The IFB–IF Hb difference, dispersion, interval, and denominator remain unverified. The original CX is preserved, and the ±1.1 from another combination arm is not filled in as SD/SE or a CI. No arbitrary minimum sample size or important difference is created. S23	The original inputs for the precision of the principal comparison and the criterion for importance have not been verified.	Original information on the type of dispersion measure, CI, analysis count (n), and a justified important Hb difference for the principal IFB/IF comparison.	Compare the original table footnotes, analysis model, and intervals, and review the scope of interpretation by comparing them with the defined important difference.
17	Met	Full text not readStored summary read	N17 · Attribution of the combination-arm valueHas 5.4±1.1 g/L been excluded from the effect of adding B2 alone?Required	The abstract's 5.4±1.1 g/L is for IFAB versus IF, which adds both vitamin A and B2. The original correction excluded it from the effect of adding B2 alone and did not fill in an SD/SE designation absent from the abstract. S23	The original attribution of the combination-arm number and the unverified type of dispersion measure have been preserved in the current manuscript and correction.	Original tables and footnotes that correct the attribution of results to the combination or single-addition arm, or the type of measure represented by ±.	Compare the components and results of the four arms side by side, and verify the comparison arms and definition of dispersion for each number.
18	Unverified	Full text not readStored summary read	N18 · Registration and analysis planAre Ma's Hb endpoint, time points, and analysis consistent with the prospective registration and plan?Required	Ma's trial registration identifier field (nct) is empty, and the value field in the record of the registered primary endpoint and the value comparing the study's primary endpoint with this page's endpoint (study_primary_vs_page_endpoint.value) are also empty/unverified. The fact that Hb is a reported endpoint is not converted into designation as the registered primary (1st) endpoint. S23	Independent materials for cross-checking the plan and registration are unavailable, so concordance, nonregistration, or selective reporting cannot be established.	Ma's registration, protocol, SAP, change history, and original Hb results.	Compare the status of Hb in the original plan with the actual IFB/IF report, leaving anything that cannot be cross-checked unverified.
19	Unverified	Full text not readStored summary read	N19 · Suprapto comparison valuesHave Suprapto's between-group Hb values for B2 versus iron and folate been verified?Required	Suprapto's study used alternating allocation and 5 mg for 60 days. The significant comparison in the abstract is the B2 arm versus the vitamin A arm; it does not establish an effect of B2 versus iron and folate. It is not directly pooled with Ma's randomized comparison of 1 mg for 2 months. S24	Although related materials on anemia in pregnancy are available, the between-group Hb values for the target comparison remain unverified in the current summary.	Suprapto's arm composition, Hb results for B2 versus iron/folate, dispersion/CI, and analysis count (n).	Compare the original results by arm with the significant comparison in the abstract, distinguishing B2 versus vitamin A results from results versus iron and folate.
20	Partly verified	Full text not readStored summary read	N20 · Suprapto exclusion flowHave the reasons by arm for excluding 19 of 103 participants and the Hb analysis denominators been verified?Required	Preserve the alternating allocation of 103 participants, the exclusion of 19 from analysis, and the originally reported 18.4%. The check of 18.4% in the original numerical-check record (numeric_checks) is a historical record and is not recalculated in this work. Hb denominators by arm and reasons for exclusion remain unverified. S24	The overall assignment count and the reported number excluded are available, but the analysis flow by arm has not been verified.	Suprapto's allocation/exclusion/analysis flow by arm, reasons for excluding 19 participants, and missing-data handling.	Review the original flow diagram to verify the distribution by arm of the 19 excluded participants and the originally reported 18.4%; do not generate an analysis count (n) by totaling the remaining participants.
21	Met	Full text not readStored summary read	N21 · RIBOFEM as one study familyDo the S10 protocol and the S11 results citation belong to the same RIBOFEM study family?Required	The study identifier (study_id) for S10 and S11 is RIBOFEM. S10 is a protocol involving healthy women with low B2 status, and S11 is the results citation for the same study family, with full-text effect values unverified. The 2 reports are not newly counted as 2 trials. S10 S11	The original study identifier (study_id) and report role (role) specify the shared study family and the difference in report types.	Original bibliographic and registration materials that correct the identity relationship between the RIBOFEM protocol and results.	Cross-check the protocol/results linkage using registration, authorship, and recruitment information; do not count reports from the same study family as separate trials.
22	Met	Full text not readStored summary read	N22 · Healthy women and design assumptionsHave the healthy women with low B2 status and the Hb assumptions for sample-size planning been excluded from observed treatment effects?Required	RIBOFEM involves healthy young women with low B2 status. The Hb difference used for sample-size planning was not used as an observed treatment effect, and no unverified numerical effect values for S11 were created. S10 S11	The exclusion boundaries for the population, design assumptions, and unverified results were verified in the preserved original results/bibliographic records.	Original materials that correct the attribution of RIBOFEM's actual results, population, and design assumptions.	Compare the protocol assumptions with the results tables to separate the Hb difference used for planning from observed values, and reassess the direct relevance of the population.
23	Unverified	Full text not readStored summary read	N23 · Direct replicationHas the same IFB/IF question been replicated in a separate independent study family?Required	The original R1 refers to Ma's decisive trial supporting the principal comparison. Suprapto's different dose and alternating allocation, and RIBOFEM's different population and reports from the same study family, were not verified as independent replications of the exact principal comparison. S23 S24 S10 S11	Independent replication of the exact add-on question has not been verified in this input, and the number of reports is not substituted for the number of replications.	Population, product, dose, duration, IFB/IF Hb results, and study-family linkage information for an independent trial.	Compare distinct study families and comparison conditions to assess whether reports with other doses/designs or healthy women are exact replications.
24	Unverified	Full text not readStored summary read	N24 · Funding and interestsHave funding, product provision, and author interests been verified for each relevant report?Supplementary; required for independence claims	The funding information for the 4 evidence entries is preserved as unverified or not used in this page's grade. Distinguish the original treatment under I1/precedent 29 from actual verification of independent funding. S23 S24 S10 S11	The original I1 axis alone does not verify funding, product provision, or conflicts of interest (COI) for each report.	Original declarations of funding, product provision, and conflicts of interest (COI) for each Ma/Suprapto/RIBOFEM report.	Compare each report's declarations with institutional support and product provision, without concluding that unverified funding is independent funding or evidence of bias.
25	Not applicable	Full text not readStored summary read	N25 · Extension to the optimal doseDoes this Hb question require a judgment on the optimal dose of 1 mg versus 5 mg?Conditional; required when extending the question to dose comparisons	The Ma 1 mg and Suprapto 5 mg materials concern different study designs, populations, and comparison conditions. These differences are not used to judge the optimal dose or dose–response, and an optimal-dose trial is not imposed on the current 1 mg question. S23 S24	The optimal dose is a separate extension requirement outside the narrow principal question. The unverified status of direct comparison data remains recorded in the observations.	If a separate dose comparison is reviewed: a direct randomized comparison of doses in the same population, with its plan and results.	If the extended question is approved, review a randomized comparison of doses in the same population with Hb and harms predefined for each dose.
26	Not applicable	Full text not readStored summary read	N26 · Extension to postpartum effects and persistenceDoes this question require a judgment on persistence beyond 2 months or on postpartum effects?Conditional; required for an extension to persistence	The original duration is 2 months, and long-term and postpartum persistence remain unverified. Do not add a long-term maintenance trial as a mandatory requirement for the narrow principal question covering 2 months. S23	Efficacy during maintenance or postpartum is a separate question outside the scope of the current comparison.	If the question is extended to persistence: denominators and time points for Hb after treatment discontinuation, postpartum, and over the long term, together with separate plans and results.	For an extended question, review designs that distinguish the end of treatment, discontinuation, and postpartum time points while tracking Hb and changes in the shared treatment.
27	Not applicable	Full text not readStored summary read	N27 · Hb and clinical eventsDoes the Hb question require evidence of benefit for maternal and fetal clinical events?Conditional; required for an extension to clinical events	Hb is the original surrogate laboratory endpoint, designated S. Do not extend it to confirmation of clinical-event prevention or safety, and do not impose a clinical-event trial on the Hb comparison itself. S23	The current single question concerns Hb change; benefit in clinical events is a separate extension. Unverified harms remain unverified under the following safety conditions.	If the question is extended to clinical events: definitions of maternal/fetal events, denominators, follow-up, and results of the planned comparisons.	For an extended question, define maternal/fetal events as endpoints separate from Hb and review the relevant direct comparison and follow-up.
28	Unverified	Full text not readStored summary read	N28 · Collection of harms by armHave the definitions of adverse events and discontinuation, and the denominators for each IFB/IF arm, been verified?Supplementary; required for comparative safety claims	Adverse-event denominators by arm and long-term maternal/fetal outcomes remain unverified in the accessed materials. Do not derive a claim of safety, AE 0, or risk rates solely from the existence of a study in pregnant women or the allocation of 91/93 participants. S23	Harm collection, aggregation, and denominators cannot be verified from the current input.	Ma IFB/IF harm-collection methods; tables of adverse events (AE), serious adverse events (SAE), and discontinuations; participant/event counts; and denominators and follow-up by arm.	Distinguish events from participants in the original harm tables, compare follow-up and discontinuations by arm, and do not convert unreported or unobtained data into 0 events.
29	Unverified	Full text not readStored summary read	N29 · Pregnancy and long-term safetyHave long-term maternal/fetal harms and their timing in relation to exposure been verified?Supplementary; required for an extension to pregnancy safety	Long-term maternal/fetal outcomes remain unverified in the materials accessed in this work. No conclusion is drawn about safety across all doses and formulations, and this is not advice to stop or replace the shared iron–folate treatment. S23	A short Hb comparison and pregnancy exposure alone cannot establish long-term safety or safety at other doses.	Exposure by stage of pregnancy; timing of maternal/fetal event onset and discontinuation; and long-term follow-up results.	Compare the stage of pregnancy with the exposure timeline, and review rare events and fetal outcomes separately with appropriate long-term follow-up.
30	Unverified	Full text not readStored summary read	N30 · Assay interferenceHas Hb assay interference for this question been checked separately?Supplementary; needed to interpret measurements	The assay-interference value field (assay_interference.value) is empty, and no separate search was conducted. The absence of a separate systematic search does not establish the absence of interference. No additional external interference materials are being read in this work either. S23	There is no record of a separate interference check having been performed, nor are the corresponding direct materials available.	The actual Hb assay method, data on testing for B2 interference, and search records for that scope.	Compare the original assay with interference experiments, and review clinical Hb change and the possibility of analytical interference separately.
31	Unverified	Full text not readStored summary read	N31 · Limits concerning drugs and concomitant useHave drug interactions beyond the shared treatment been comprehensively verified?Supplementary; required for an extension to safety of concomitant use	The drug-interaction field (drug_interactions) is empty, and no separate search was conducted; no separate comprehensive search of all drug interactions was performed. Total intake also remains unverified. Do not turn a nominal comparison of the shared iron–folate treatment into comprehensive verification of interactions. S23	Identifying some concomitant treatments and verifying all drug interactions are different scopes of work.	Participants' complete lists of concomitant treatments; interaction/exposure data; and the original search scope.	Compare concomitant use and actual exposure by arm, and review drug-interaction data and areas not searched separately.
32	Met	Full text not readStored summary read	N32 · Current and historical readingHas reading the summaries in this work been distinguished from each report's historical access and from the fact that external materials have not been read in this work?Required	This work involved actually reading the currently retained Korean/English (KO/EN) summaries. The original records for S23's indexed author abstract, S24's publisher abstract, S10's full-text HTML article, and S11's provided bibliographic extraction describe historical access. No access-date key exists for each citation record (citation), so these values are left empty; 2026-09-15 is distinguished as the original review date for the record as a whole. Access to the four external links was not attempted, and their materials were not read in this work. S23 S24 S10 S11	Current reading, material types, historical access, and the absence of individual access dates were distinguished in accordance with the actual input schema.	Corrections to each report's original access record/access date, link, and material type, or an actual material-acquisition event.	Compare each report's citation record (citation) with its access history, link the summary viewer (reader) to the original location, and record any actual reading of external materials only as a separate event.
33	Met	Full text not readStored summary read	N33 · Scope of searches and correctionsHave the original search cutoff, corrections, and the scope of activities not performed in this work been stated explicitly?Required	The original search cutoff and verification date (search_cutoff/verified_date) are 2026-09-15. This was not an exhaustive search of primary databases worldwide; the preservation conversion recorded here is dated 2026-10-05. The separate original search log (search_log), numerical evidence file (numeric_evidence), and report files were not opened, and no new search or calculation was performed. S23 S24 S10 S11	The scope of preservation checks and the activities not performed in this work were stated explicitly, without converting an absence of searching into 0 human studies.	Original search and selection/correction logs, or a new official correction or full-text acquisition event.	Compare the original records of existing searches and corrections, and, if a new evidence review is separately approved, update them while recording dates, inclusion/exclusion decisions, and material levels.
34	Met	Full text not readStored summary read	N34 · Original judgment and historical valuesHave the original C·46, all assessment axes, empty values, and historical arithmetic been preserved unchanged?Required	Preserve the original C·46, B/S/R1/I1/EX/B1/CX, and the flag indicating whether there are no human studies (no_human_study=false). The original allocation total of 184 and arithmetic check of 18.4% were read as historical descriptive values; no new calculations, efficacy/safety scores, or condition-fulfillment rates were created. S23 S24 S10 S11	Preservation of all values in their original form throughout the source was distinguished from the new table's unscored status. This is neither independent clinical certification nor a new judgment.	An official correction concerning the original judgment, assessment axes, empty values, arithmetic, or sources/identity.	Compare the complete original text before and after a correction, link only the changed identities/values to their supporting evidence and dates, and distinguish revision of the conditions version from a new judgment.

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence date: 2026-09-15
Scope actually checked: Preserved Korean and English manuscripts and case-specific records of criteria and their application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the preserved materials were reviewed, not the date of a new search of the clinical literature.
Population: Pregnant women selected for anemia by Hb; not all confirmed to have iron-deficiency anemia
Ingredient, formulation and route: Supplementation with added riboflavin (vitamin B2)
Dose: The principal analysis question concerns adding B2 1.0 mg/day; the 5 mg from another study is not pooled with it
Comparator: The same iron 60 mg/day and folic acid 400 μg/day; excludes arms with added vitamin A
Measured outcome: Between-group difference in the change in blood Hb concentration; distinguished from anemia prevalence and combined-nutrient results
Duration: The principal analysis question covers 2 months; longer-term and postpartum persistence remain unverified
Questions outside this scope: Does this Hb question require a judgment on the optimal dose of 1 mg versus 5 mg?; Does this question require a judgment on persistence beyond 2 months or on postpartum effects?; Does the Hb question require evidence of benefit for maternal and fetal clinical events?

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.

S23 · Ma et al. — retinol/riboflavin added to iron and folate in anemic pregnant women (2008)

Official source

Material type: Direct add-on comparison; actual route unverified
Materials actually read: Summary reading: the currently preserved, retained summaries were actually read. Access to external original materials was not attempted, and they were neither obtained nor read in this work.
Findings recorded in the stored summary: The IFB–IF Hb effect size and dispersion for adding B2 alone remain unverified. The total of 366, IFB 91, and IF 93 are allocation counts and must not be substituted for analysis denominators. The 5.4±1.1 g/L value belongs to the IFAB combination arm, and what the ± represents is unspecified.
Record level: Direct add-on comparison; actual route unverified
Study overlap and independent replication: Do not newly count the 4 reports as 4 unique trials or independent replications. Preserve the original R1 and each material's status as direct evidence, contextual evidence, or unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed article abstract and bibliographic page	Currently unverified	External access not attempted in this work	Unread	Direct add-on comparison; actual route unverified; access to external original materials was not attempted, and they were neither obtained nor read in this work.

S24 · Suprapto et al. — riboflavin added to iron–folate in anemic pregnant women (2002)

Official source

Material type: Contextual evidence with a different dose, allocation method, and comparison
Materials actually read: Summary reading: the currently preserved, retained summaries were actually read. Access to external original materials was not attempted, and they were neither obtained nor read in this work.
Findings recorded in the stored summary: 103 participants were alternately allocated; B2 was 5 mg for 60 days; 19 participants were excluded (originally reported as 18.4%). The significant comparison in the abstract was B2 versus vitamin A, and the between-arm Hb value for B2 versus iron–folate could not be verified.
Record level: Contextual evidence with a different dose, allocation method, and comparison
Study overlap and independent replication: Do not newly count the 4 reports as 4 unique trials or independent replications. Preserve the original R1 and each material's status as direct evidence, contextual evidence, or unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Publisher's article abstract webpage	Currently unverified	External access not attempted in this work	Unread	Contextual evidence with a different dose, allocation method, and comparison; access to external original materials was not attempted, and they were neither obtained nor read in this work.

S10 · RIBOFEM protocol — riboflavin status and hematology in young women

Official source

Material type: Different population; study design, not observed results
Materials actually read: Summary reading: the currently preserved, retained summaries were actually read. Access to external original materials was not attempted, and they were neither obtained nor read in this work.
Findings recorded in the stored summary: This is a protocol for healthy young women with low B2 status. Hb assumptions used for sample-size planning are not used as observed effects, and the protocol is excluded from direct evidence for anemic pregnant women.
Record level: Different population; study design, not observed results
Study overlap and independent replication: Do not newly count the 4 reports as 4 unique trials or independent replications. Preserve the original R1 and each material's status as direct evidence, contextual evidence, or unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Full-text study protocol on the web (HTML)	Currently unverified	External access not attempted in this work	Unread	Different population; study design, not observed results; access to external original materials was not attempted, and they were neither obtained nor read in this work.

S11 · Correcting marginal riboflavin deficiency and hematologic status in young UK women (2011)

Official source

Material type: Result details unverified within the same trial family
Materials actually read: Summary reading: the currently preserved, retained summaries were actually read. Access to external original materials was not attempted, and they were neither obtained nor read in this work.
Findings recorded in the stored summary: This belongs to the same RIBOFEM family as S10. The original bibliographic and access records are reused; effect values from the full results article are not filled in as values verified in this work.
Record level: Result details unverified within the same trial family
Study overlap and independent replication: Do not newly count the 4 reports as 4 unique trials or independent replications. Preserve the original R1 and each material's status as direct evidence, contextual evidence, or unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed bibliographic and abstract page for the results article	Currently unverified	External access not attempted in this work	Unread	Result details unverified within the same trial family; access to external original materials was not attempted, and they were neither obtained nor read in this work.

Report counts versus independent study counts

Do not newly count the 4 reports as 4 unique trials or independent replications. Preserve the original R1 and each material's status as direct evidence, contextual evidence, or unverified.

Review criteria

Version NGM-v3088-B2-IFB-IF-ANEMIC-PREGNANCY-HB-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 · Is the single question in this table IFB versus IF, with only B2 added to the same iron and folate?

Required materials and conditions: Corrections to the definition of the current claim being judged, population, IFB/IF components, endpoint, and timeframe, or new original source material.
Conditions for verification: The question remains anchored at its original source location: a comparison adding only B2 to the same iron and folate treatment in pregnant women selected for anemia by Hb, with change in blood Hb as the outcome.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information about this single question on an added treatment with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria for a single question about an added treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: Question-clarification principles in M03 §3.1 and §3.2.1–3.2.4; detailed rules for separating comparisons are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for a single question about an added treatment.

N02 · Have the Hb eligibility criteria, stage of pregnancy, and baseline characteristics of the anemic pregnant women been verified?

Required materials and conditions: Ma’s Hb eligibility threshold, gestational age, recruitment/exclusion criteria, and baseline-characteristics table by arm.
Conditions for verification: The Hb eligibility threshold, stage of pregnancy, recruitment/exclusion criteria, and baseline Hb can be linked to the relevant IFB/IF population.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the selection of anemic pregnant women with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria for selecting anemic pregnant women must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed — an internal adaptation for the selection of anemic pregnant women.

N03 · Have the causes of anemia and the presence or absence of iron deficiency in IFB/IF participants been classified?

Required materials and conditions: Diagnostic methods for each cause of anemia, iron-status indicators, the composition of the IFB/IF arms by cause, and separate results by cause.
Conditions for verification: The methods for determining iron deficiency and other causes, and the composition of each arm, are linked to the relevant participants.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the causes of anemia with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning the causes of anemia must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the causes of anemia.

N04 · Have baseline B2 status and the method for identifying deficiency in Ma’s participants been verified?

Required materials and conditions: Ma’s methods for measuring baseline vitamin status, deficiency thresholds, distributions by arm, and prespecified analysis plan.
Conditions for verification: Verify participants’ baseline B2 indicators/thresholds and distributions, and the plan for analyzing effect modification.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on baseline B2 status with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning baseline B2 status must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for baseline B2 status.

N05 · Have the molecule, product, and detailed formulation of the B2 preparation actually used been verified?

Required materials and conditions: Information on the composition/product, detailed formulation, release profile, and manufacture of Ma’s trial preparation.
Conditions for verification: The identity of riboflavin is linked to the product, formulation, release profile, and information on actual administration.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the molecule and formulation with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning the molecule and formulation must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the molecule and formulation.

N06 · Is the actual route of administration in Ma’s IFB/IF arms explicitly stated?

Required materials and conditions: Methods material explicitly stating Ma’s actual route of administration and formulation.
Conditions for verification: Verify the route of administration in the decisive study’s actual Methods section. An oral-route label in the target question alone does not meet this criterion.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the actual route of administration with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning the actual route of administration must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the actual route of administration.

N07 · Is the nominal added B2 dose in the principal comparison 1.0 mg/day?

Required materials and conditions: Corrections to Ma’s supplementation doses by arm, or records of actual administration.
Conditions for verification: The nominal B2 supplementation dose for IFB versus IF matches the original data structure. It is distinguished from actual intake and adherence.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the added B2 dose with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning the added B2 dose must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for the added B2 dose.

N08 · Have the shared iron and folate in IFB and IF, and the excluded combination arms, been fixed?

Required materials and conditions: Corrections to the shared treatment in IFB/IF, records of actual concomitant treatment/changes, and information on arm composition.
Conditions for verification: Fix the question as a comparison differing only in B2 on top of the same iron 60 mg/day and folic acid 400 μg/day. Do not transfer results from an arm that also adds vitamin A.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on shared iron and folate with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning shared iron and folate must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for shared iron and folate.

N09 · Is supplementation in the principal IFB/IF question given for 2 months?

Required materials and conditions: Corrections to the duration of Ma’s principal comparison, and the measurement schedule.
Conditions for verification: Link the 2-month duration of the principal comparison to the original data structure, and distinguish it from longer-term and postpartum follow-up.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the duration of the principal comparison with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning the duration of the principal comparison must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the duration of the principal comparison.

N10 · Have Ma’s random sequence, allocation concealment, and blinding procedures been verified?

Required materials and conditions: Ma’s random sequence, allocation concealment and blinding methods, and baseline table by arm.
Conditions for verification: Verify random sequence generation, concealment, blinded assessment, and baseline balance for the relevant IFB/IF comparison.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on allocation and blinding with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning allocation and blinding must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M08 §8.1–8.2.3; internal application — an internal adaptation for allocation and blinding.

N11 · Have actual adherence, rescue treatment, and total exposure in IFB/IF been verified?

Required materials and conditions: Records by arm of intake/adherence, rescue treatment, changes to iron/folate, diet, and other supplements.
Conditions for verification: Link actual intake, deviations, changes in concomitant treatment, total dietary/supplement exposure by arm, and the methods used to handle these.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on adherence and changes in concomitant treatment with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning adherence and changes in concomitant treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for adherence and changes in concomitant treatment.

N12 · Have the Hb measurement methods, units, time points, and assessment procedures in IFB/IF been verified?

Required materials and conditions: Ma’s Hb assay methods, units, baseline/end-of-treatment measurement table, and information on blinded assessment.
Conditions for verification: Link the actual assay methods, time points, baseline/end-of-treatment values, and assessment procedures for changes in blood Hb to the relevant result.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on Hb measurement with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The criteria concerning Hb measurement must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a and M03 §3.2.4; internal application — an internal adaptation for Hb measurement.

N13 · Have the actual analysis population, adjustment, and definition of change for IFB versus IF been verified?

Required materials and conditions: The IFB/IF analysis plan, ITT/PP populations, adjustment model, definition of change, and original results tables.
Conditions for verification: Link the analytical definitions of the effect of assignment or adherence, ITT/PP, adjustment, and baseline/final values or change to the actual IFB/IF results.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the effect of interest and analysis with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning the effect of interest and analysis must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 §8.2.2, M15 §15.3.1; application for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet — an adaptation for this sheet concerning the effect of interest and analysis.

N14 · Have the 366 participants assigned overall and the 91/93 assigned to the two arms been linked to the actual Hb analysis denominators?

Required materials and conditions: Ma's IFB/IF participant flow diagram, measurement and analysis counts (n), reasons for exclusion, and table of missing-data handling.
Conditions for verification: Link recruitment → allocation to four arms → Hb measurement → analysis denominators, together with exclusions and missing-data handling, separately for IFB and IF.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on allocation and analysis denominators with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning allocation and analysis denominators must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning allocation and analysis denominators.

N15 · Has the between-group Hb effect size for IFB versus IF been verified?

Required materials and conditions: Ma's Hb values by IFB/IF arm, between-group estimate, definitions, and original tables.
Conditions for verification: Verify the original between-group Hb effect size, units, and definition of the estimate for the comparison that adds only B2 to the same iron and folate treatment.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on the Hb difference from adding B2 alone with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning the Hb difference from adding B2 alone must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning the Hb difference from adding B2 alone.

N16 · Have the type of dispersion measure, CI, and criterion for an important difference for IFB/IF been verified?

Required materials and conditions: Original information on the type of dispersion measure, CI, analysis count (n), and a justified important Hb difference for the principal IFB/IF comparison.
Conditions for verification: Verify the type of measure, such as SD/SE, the analysis count (n), and CI for the principal estimate, together with a justified criterion for an important Hb difference.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on dispersion and intervals with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning dispersion and intervals must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning dispersion and intervals.

N17 · Has 5.4±1.1 g/L been excluded from the effect of adding B2 alone?

Required materials and conditions: Original tables and footnotes that correct the attribution of results to the combination or single-addition arm, or the type of measure represented by ±.
Conditions for verification: Attribute 5.4±1.1 g/L to IFAB versus IF, in which A+B2 are added together; do not repurpose it as an effect of B2 alone or as an identified type of dispersion measure.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on attribution of the combination-arm value with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning attribution of the combination-arm value must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M03 §3.2.2–3.2.3; reverse-direction markers and adaptations of checks were designed for this sheet; M03 §3.2.3, M08 §8.2.2–8.2.3; application for this sheet — an adaptation for this sheet concerning attribution of the combination-arm value.

N18 · Are Ma's Hb endpoint, time points, and analysis consistent with the prospective registration and plan?

Required materials and conditions: Ma's registration, protocol, SAP, change history, and original Hb results.
Conditions for verification: Compare the reported information with the endpoint status, time points, and analysis specified in the registration, protocol, and SAP for the principal comparison.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on registration and the analysis plan with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning registration and the analysis plan must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; application for this sheet — an adaptation for this sheet concerning registration and the analysis plan.

N19 · Have Suprapto's between-group Hb values for B2 versus iron and folate been verified?

Required materials and conditions: Suprapto's arm composition, Hb results for B2 versus iron/folate, dispersion/CI, and analysis count (n).
Conditions for verification: Link the actual comparison values and intervals for B2 versus iron and folate, with alternating allocation and 5 mg/60 days, to the corresponding population and denominators.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on Suprapto's comparison values with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning Suprapto's comparison values must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M08 §8.1–8.2.3; application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning Suprapto's comparison values.

N20 · Have the reasons by arm for excluding 19 of 103 participants and the Hb analysis denominators been verified?

Required materials and conditions: Suprapto's allocation/exclusion/analysis flow by arm, reasons for excluding 19 participants, and missing-data handling.
Conditions for verification: Link the total assigned by alternating allocation, reasons for exclusion by arm, actual Hb analysis counts (n), and handling methods.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on Suprapto's exclusion flow with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning Suprapto's exclusion flow must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.1–8.2.3; application for this sheet — an adaptation for this sheet concerning Suprapto's exclusion flow.

N21 · Do the S10 protocol and the S11 results citation belong to the same RIBOFEM study family?

Required materials and conditions: Original bibliographic and registration materials that correct the identity relationship between the RIBOFEM protocol and results.
Conditions for verification: Link the preserved study identifier (study_id) and relationships, so that the protocol and results reports are not counted as new independent trials.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on RIBOFEM as one study family with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning RIBOFEM as one study family must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning RIBOFEM as one study family.

N22 · Have the healthy women with low B2 status and the Hb assumptions for sample-size planning been excluded from observed treatment effects?

Required materials and conditions: Original materials that correct the attribution of RIBOFEM's actual results, population, and design assumptions.
Conditions for verification: Do not use RIBOFEM's selection of healthy women and sample-size planning assumptions as actual IFB/IF treatment effects in anemic pregnant women.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on healthy women and design assumptions with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning healthy women and design assumptions must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.1; detailed population conditions were designed for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning healthy women and design assumptions.

N23 · Has the same IFB/IF question been replicated in a separate independent study family?

Required materials and conditions: Population, product, dose, duration, IFB/IF Hb results, and study-family linkage information for an independent trial.
Conditions for verification: Link actual results from an independent study family that is eligible in terms of the same population, addition of B2 alone, duration/dose, and Hb analysis.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified information on direct replication with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning direct replication must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning direct replication.

N24 · Have funding, product provision, and author interests been verified for each relevant report?

Required materials and conditions: Original declarations of funding, product provision, and conflicts of interest (COI) for each Ma/Suprapto/RIBOFEM report.
Conditions for verification: Verify the actual funding, provision, and author declarations for each report and its study-family relationships at the recorded source locations.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Do not fill gaps in unverified information on funding and interests with another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning funding and interests must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methods sections used in this pilot do not endorse all of these detailed items — an adaptation for this sheet concerning funding and interests.

N25 · Does this Hb question require a judgment on the optimal dose of 1 mg versus 5 mg?

Required materials and conditions: If a separate dose comparison is reviewed: a direct randomized comparison of doses in the same population, with its plan and results.
Conditions for verification: Preserve the current question of adding 1 mg, and do not remove that narrow question because a separate dose comparison is unavailable.
Requirement and applicability: Conditional; required when extending the question to dose comparisons
Application exceptions: Proof of the optimal dose is not imposed as a requirement for the narrow question of adding 1 mg.
Why this condition is needed: The conditions concerning an extension to the optimal dose must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification were designed for this sheet — an adaptation for this sheet concerning an extension to the optimal dose.

N26 · Does this question require a judgment on persistence beyond 2 months or on postpartum effects?

Required materials and conditions: If the question is extended to persistence: denominators and time points for Hb after treatment discontinuation, postpartum, and over the long term, together with separate plans and results.
Conditions for verification: Distinguish the principal 2-month comparison from separate questions about the long term, discontinuation, or the postpartum period.
Requirement and applicability: Conditional; required for an extension to persistence
Application exceptions: Do not impose evidence of long-term maintenance as a requirement for the 2-month effect question.
Why this condition is needed: The conditions for an extension to postpartum effects and persistence must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.1–3.2.4; the details concerning dose, persistence, and effect modification were developed for this assessment — an adaptation for the extension to postpartum effects and persistence.

N27 · Does the Hb question require evidence of benefit for maternal and fetal clinical events?

Required materials and conditions: If the question is extended to clinical events: definitions of maternal/fetal events, denominators, follow-up, and results of the planned comparisons.
Conditions for verification: Separate the question about change in Hb values from questions about clinical events, quality of life, mortality, or birth outcomes.
Requirement and applicability: Conditional; required for an extension to clinical events
Application exceptions: Do not impose a clinical-event trial as a requirement for a question about the Hb value itself.
Why this condition is needed: The conditions concerning Hb and clinical events must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.4; limits on extensions were developed for this assessment; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to each question were developed for this assessment — an adaptation for Hb and clinical events.

N28 · Have the definitions of adverse events and discontinuation, and the denominators for each IFB/IF arm, been verified?

Required materials and conditions: Ma IFB/IF harm-collection methods; tables of adverse events (AE), serious adverse events (SAE), and discontinuations; participant/event counts; and denominators and follow-up by arm.
Conditions for verification: Verify event/participant counts, systematic collection, severity, discontinuations, exposure and analysis denominators by arm, and duration.
Requirement and applicability: Supplementary; required for comparative safety claims
Application exceptions: Do not fill gaps in unverified data on collection of harms by arm using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for collection of harms by arm must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M19 §19.1.2–19.2.4; application developed for this assessment; M19 §19.1.2–19.2.4; detailed distinctions were developed for this assessment; M19 §19.2.2–19.2.4, M03 §3.2.3; application developed for this assessment; M19 §19.1.2–19.2.4, M04 §4.6.3; application developed for this assessment — an adaptation for collection of harms by arm.

N29 · Have long-term maternal/fetal harms and their timing in relation to exposure been verified?

Required materials and conditions: Exposure by stage of pregnancy; timing of maternal/fetal event onset and discontinuation; and long-term follow-up results.
Conditions for verification: Verify the stage of pregnancy, exposure/event onset, long-term maternal/fetal follow-up, and the actual scope of event reporting.
Requirement and applicability: Supplementary; required for an extension to pregnancy safety
Application exceptions: Do not fill gaps in unverified pregnancy and long-term safety data using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for pregnancy and long-term safety must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M19 §19.1.2–19.2.4; application developed for this assessment; harm questions by study design in M19 §19.2; details of temporal relationships were developed for this assessment; Chamgap's own limits on interpretation. This draws on M19 principles and is not an application of an official causality tool — an adaptation for pregnancy and long-term safety.

N30 · Has Hb assay interference for this question been checked separately?

Required materials and conditions: The actual Hb assay method, data on testing for B2 interference, and search records for that scope.
Conditions for verification: Distinguish the scope in which interference between the Hb assay method and B2 exposure was directly checked from areas that were not searched.
Requirement and applicability: Supplementary; needed to interpret measurements
Application exceptions: Do not fill gaps in unverified assay-interference data using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for assay interference must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for assay interference.

N31 · Have drug interactions beyond the shared treatment been comprehensively verified?

Required materials and conditions: Participants' complete lists of concomitant treatments; interaction/exposure data; and the original search scope.
Conditions for verification: Link the scope of verification and searches concerning concomitant drug/supplement use and interactions to the actual records.
Requirement and applicability: Supplementary; required for an extension to safety of concomitant use
Application exceptions: Do not fill gaps in unverified data on the limits concerning drugs and concomitant use using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions concerning limits on drugs and concomitant use must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; application developed for this assessment; M19 §19.1.2–19.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for limits concerning drugs and concomitant use.

N32 · Has reading the summaries in this work been distinguished from each report's historical access and from the fact that external materials have not been read in this work?

Required materials and conditions: Corrections to each report's original access record/access date, link, and material type, or an actual material-acquisition event.
Conditions for verification: Record the actual reading of the currently retained summaries and, for each external material, that access was not attempted and the material was neither obtained nor read in this work; preserve historical access levels and original locations separately.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified data on current and historical reading using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for current and historical reading must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: Material-collection and selection principles in M04 §4.5–4.6; the distinction between access and reading and the rules governing hyperlinks were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for current and historical reading.

N33 · Have the original search cutoff, corrections, and the scope of activities not performed in this work been stated explicitly?

Required materials and conditions: Original search and selection/correction logs, or a new official correction or full-text acquisition event.
Conditions for verification: Link the preserved search cutoff, revisions, and unverified items to the scope of new searches, full-text reading, and calculations not performed in this work.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified data on the scope of searches and corrections using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for the scope of searches and corrections must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment; M04 §4.6.3, M15 §15.3.1–15.3.3; distinctions between statuses were developed for this assessment — an adaptation for the scope of searches and corrections.

N34 · Have the original C·46, all assessment axes, empty values, and historical arithmetic been preserved unchanged?

Required materials and conditions: An official correction concerning the original judgment, assessment axes, empty values, arithmetic, or sources/identity.
Conditions for verification: Preserve the current original grade and score (grade/score), assessment axes, statuses, all values in their original form, and historical arithmetic separately from any new assessment of conditions.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in unverified data on the original judgment and historical values using another study, allocation counts, or a different comparison in a title or abstract.
Why this condition is needed: The conditions for the original judgment and historical values must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for the original judgment and historical values.

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 document the question, eligibility conditions and reasons for changes, and distinguish intervention variants.
Extent of review: Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool.

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; do not omit studies solely because results are unreported.
Extent of review: Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool.

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

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

Referenced principle: Fix the outcome and effect of interest when reviewing randomization, attrition, missing data, measurement and selective reporting.
Extent of review: Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool.

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 values, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: Reuse of the preserved methods copy and historical principles from 1585. This is neither a new review of the full methods text nor certification through an official tool.

What the statuses mean

Met: The identity, original attribution, and scope of this condition were verified in the retained materials. This is separate from the sufficiency of the effect or clinical certification.
Partly verified: Some materials have been linked, but the actual analyses, procedures, or details remain to be verified.
Unverified: The clinical materials or values needed for this condition remain unverified within the scope of this reading. This is distinct from an effect of 0, AE 0, or incomplete table preparation.
Not applicable: An obligation to extend beyond the narrow principal question does not apply. This does not substitute for an unread status or a gap in the materials.
Not applicable (alias): A gray display alias for Not applicable.
Conflicting data: An actual discrepancy in the original sources for the same item; distinct from numerical differences between different comparisons.
Unread: External original materials have not been directly read in the current work; this is separate from actually reading the retained summaries.
Review incomplete: An individual review for preparing the table is incomplete; this is separate from unverified materials.

Change history

2026-11-01 · Public page/material version 1.0

A public display and data were created from the existing 34 items. No new clinical search, change to verification status, or scoring was performed.

The stored-material review date (2026-10-05) and original evidence cut-off (2026-09-15) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Is the single question in this table IFB versus IF, with only B2 added to the same iron and folate?

Current findings: The original effect field (/ko/effect) and the definition of the question being judged fix the outcome as an increase in Hb in anemic pregnant women receiving iron and folate. The principal comparison is Ma’s IFB versus IF, distinguished from the IFAB combination arm and from anemia treatments as a whole.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The definition of the single original principal comparison (main) and its exclusion boundaries were verified in the currently preserved manuscript. This is separate from verifying the magnitude of the Hb effect.
Reason for missing information: The principal IFB versus IF comparison and the scope of exclusions were verified. This does not mean that the magnitude of the Hb effect was verified, and external original source material was not directly read in this work.
Required materials and conditions: Corrections to the definition of the current claim being judged, population, IFB/IF components, endpoint, and timeframe, or new original source material.
Materials to obtain first: Corrections to the definition of the current claim being judged, population, IFB/IF components, endpoint, and timeframe, or new original source material.
Further research: Compare the components of each arm against the question-definition table and review the selection decisions that exclude vitamin A add-on arms and the anemia-prevalence question.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: The question remains anchored at its original source location: a comparison adding only B2 to the same iron and folate treatment in pregnant women selected for anemia by Hb, with change in blood Hb as the outcome.
Why this condition is needed: The criteria for a single question about an added treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information about this single question on an added treatment with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: Question-clarification principles in M03 §3.1 and §3.2.1–3.2.4; detailed rules for separating comparisons are internally designed; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for a single question about an added treatment.

Related sources S23

N02 · Have the Hb eligibility criteria, stage of pregnancy, and baseline characteristics of the anemic pregnant women been verified?

Current findings: The population consists of pregnant women selected for anemia by Hb. The current manuscript does not provide the Hb threshold, gestational age, detailed inclusion/exclusion criteria, or the complete baseline characteristics by arm as verified information.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The population has been identified as pregnant women with anemia, but material is still needed to verify the detailed selection criteria and baseline distributions.
Reason for missing information: The population was verified as pregnant women with anemia, but the Hb eligibility threshold, gestational age, recruitment and exclusion criteria, and complete baseline characteristics by arm remain unverified.
Required materials and conditions: Ma’s Hb eligibility threshold, gestational age, recruitment/exclusion criteria, and baseline-characteristics table by arm.
Materials to obtain first: Ma’s Hb eligibility threshold, gestational age, recruitment/exclusion criteria, and baseline-characteristics table by arm.
Further research: Compare the original eligibility criteria with the flow diagram and baseline table to extract the Hb definition and stage of pregnancy, and review limitations on applicability to other maternal populations.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: The Hb eligibility threshold, stage of pregnancy, recruitment/exclusion criteria, and baseline Hb can be linked to the relevant IFB/IF population.
Why this condition is needed: The criteria for selecting anemic pregnant women must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the selection of anemic pregnant women with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed — an internal adaptation for the selection of anemic pregnant women.

Related sources S23

N03 · Have the causes of anemia and the presence or absence of iron deficiency in IFB/IF participants been classified?

Current findings: A complete classification of the causes of Hb-defined anemia remains unverified. Do not classify all participants as having iron-deficiency anemia or generalize the findings to treatment effects for all anemia.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Hb-based selection alone does not verify diagnoses by cause or the presence or absence of iron deficiency.
Reason for missing information: Diagnoses by cause and the presence or absence of iron deficiency in Hb-defined anemia, the composition of each arm by cause, and separate results by cause remain unverified. Not all participants can be confirmed to have iron-deficiency anemia.
Required materials and conditions: Diagnostic methods for each cause of anemia, iron-status indicators, the composition of the IFB/IF arms by cause, and separate results by cause.
Materials to obtain first: Diagnostic methods for each cause of anemia, iron-status indicators, the composition of the IFB/IF arms by cause, and separate results by cause.
Further research: Distinguish Hb-based selection from a diagnosis of iron deficiency, review the classification of causes, and check whether the results by cause come from planned comparisons.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: The methods for determining iron deficiency and other causes, and the composition of each arm, are linked to the relevant participants.
Why this condition is needed: The criteria concerning the causes of anemia must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the causes of anemia with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the causes of anemia.

Related sources S23

N04 · Have baseline B2 status and the method for identifying deficiency in Ma’s participants been verified?

Current findings: The full details of baseline vitamin status and the method for identifying deficiency in the principal eligible population are blank/unverified. Do not transfer the eligibility criteria for RIBOFEM’s healthy women with low B2 status to Ma’s pregnant women.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: No material is available to verify the presence or absence of B2 deficiency or its distribution in this population of pregnant women.
Reason for missing information: Methods for measuring baseline B2, deficiency thresholds, distributions by arm, and the relevant prespecified analysis plan for Ma’s pregnant women remain unverified. Do not fill this gap with the eligibility criteria for RIBOFEM’s healthy women.
Required materials and conditions: Ma’s methods for measuring baseline vitamin status, deficiency thresholds, distributions by arm, and prespecified analysis plan.
Materials to obtain first: Ma’s methods for measuring baseline vitamin status, deficiency thresholds, distributions by arm, and prespecified analysis plan.
Further research: Extract the assessment of B2 status separately from Hb-based selection, and review whether there is a planned between-group comparison within the deficient stratum.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify participants’ baseline B2 indicators/thresholds and distributions, and the plan for analyzing effect modification.
Why this condition is needed: The criteria concerning baseline B2 status must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on baseline B2 status with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.1; detailed population criteria are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for baseline B2 status.

Related sources S23 S10

N05 · Have the molecule, product, and detailed formulation of the B2 preparation actually used been verified?

Current findings: The molecule riboflavin is verified. The detailed formulation, release profile, and production origin, such as synthesis or fermentation, remain unverified in the decisive abstract. Plant-part classification does not apply to this question about a molecule.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The molecule has been verified, but the detailed formulation cannot be filled in as a verified value.
Reason for missing information: The molecule riboflavin was verified, but the detailed formulation, release profile, and production origin of the trial product remain unverified. The plant part used does not apply to this question about a molecule.
Required materials and conditions: Information on the composition/product, detailed formulation, release profile, and manufacture of Ma’s trial preparation.
Materials to obtain first: Information on the composition/product, detailed formulation, release profile, and manufacture of Ma’s trial preparation.
Further research: Compare trial-preparation records to extract the identity of riboflavin, the product, and the release profile, and exclude results for other B-vitamin types or formulations.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: The identity of riboflavin is linked to the product, formulation, release profile, and information on actual administration.
Why this condition is needed: The criteria concerning the molecule and formulation must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the molecule and formulation with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the molecule and formulation.

Related sources S23

N06 · Is the actual route of administration in Ma’s IFB/IF arms explicitly stated?

Current findings: The verdict concerns a question about oral supplementation. Ma’s abstract does not specify the route of administration or detailed formulation, so the route value in the preserved study information (route.value) is blank/not_reported.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The route specified in the question is fixed, but the actual route is not reported in the accessed decisive abstract, and the full text was not read in this work either.
Reason for missing information: The question concerns oral supplementation, but Ma’s abstract does not specify the actual route of administration or detailed formulation. The full-text methods material needed to verify these details was not read in this work.
Required materials and conditions: Methods material explicitly stating Ma’s actual route of administration and formulation.
Materials to obtain first: Methods material explicitly stating Ma’s actual route of administration and formulation.
Further research: Compare the oral-route token (oral) in the question being judged with the actual route in the trial methods as separate records, and update the verification status of the observed route.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify the route of administration in the decisive study’s actual Methods section. An oral-route label in the target question alone does not meet this criterion.
Why this condition is needed: The criteria concerning the actual route of administration must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the actual route of administration with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for the actual route of administration.

Related sources S23

N07 · Is the nominal added B2 dose in the principal comparison 1.0 mg/day?

Current findings: The dose value in the preserved study information (dose.value) and the supplementation-dose value (supplement_dose.value) are 1.0. The principal comparison adds B2 1.0 mg/day; Suprapto’s 5 mg is not pooled with it.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The nominal added dose in the principal comparison was verified in the original data structure, without extending its meaning to the dose actually taken.
Reason for missing information: The nominal added B2 dose of 1.0 mg/day was verified. Actual intake, adherence, and treatment changes are a separate area of unverified information under N11; verification of the nominal dose does not replace verification of these details.
Required materials and conditions: Corrections to Ma’s supplementation doses by arm, or records of actual administration.
Materials to obtain first: Corrections to Ma’s supplementation doses by arm, or records of actual administration.
Further research: Verify the prescribed dose in each arm, and do not add the 5 mg from another study or total dietary intake to this nominal added dose.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: The nominal B2 supplementation dose for IFB versus IF matches the original data structure. It is distinguished from actual intake and adherence.
Why this condition is needed: The criteria concerning the added B2 dose must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the added B2 dose with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for the added B2 dose.

Related sources S23

N08 · Have the shared iron and folate in IFB and IF, and the excluded combination arms, been fixed?

Current findings: The comparator receives the same iron 60 mg/day and folic acid 400 μg/day. Select IFB versus IF, with only B2 added to shared iron and folate, and exclude arms that also add vitamin A.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The nominal shared treatment and the definition of the comparison in terms of added components were verified in the original treatment descriptors (facets) and manuscript. Actual adherence remains separately unverified.
Reason for missing information: The nominal comparison was verified as adding only B2 to the same iron 60 mg/day and folic acid 400 μg/day. Actual intake, changes in concomitant treatment, and total exposure remain unverified under N11.
Required materials and conditions: Corrections to the shared treatment in IFB/IF, records of actual concomitant treatment/changes, and information on arm composition.
Materials to obtain first: Corrections to the shared treatment in IFB/IF, records of actual concomitant treatment/changes, and information on arm composition.
Further research: Compare the component tables for the four arms, and review the extent to which the shared treatment was maintained and B2 was the only difference.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Fix the question as a comparison differing only in B2 on top of the same iron 60 mg/day and folic acid 400 μg/day. Do not transfer results from an arm that also adds vitamin A.
Why this condition is needed: The criteria concerning shared iron and folate must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on shared iron and folate with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed; M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application — an internal adaptation for shared iron and folate.

Related sources S23

N09 · Is supplementation in the principal IFB/IF question given for 2 months?

Current findings: The duration of the principal question is verified as a duration value (amount) of 2, measured in months (unit). Longer-term and postpartum persistence remain unverified, and the 60 days in another study are not automatically merged as the same analysis time point.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The original data structure verifies the principal duration as 2 months, so the criterion for identifying that narrowly defined duration is met.
Reason for missing information: The 2-month supplementation period in the principal comparison was verified. The complete actual Hb measurement schedule remains unverified under N12, and the 2 months are not extended to imply verification of longer-term or postpartum effects.
Required materials and conditions: Corrections to the duration of Ma’s principal comparison, and the measurement schedule.
Materials to obtain first: Corrections to the duration of Ma’s principal comparison, and the measurement schedule.
Further research: Compare the start and end of administration with the timing of Hb measurements to distinguish the nominal 2 months from the actual observation period.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the 2-month duration of the principal comparison to the original data structure, and distinguish it from longer-term and postpartum follow-up.
Why this condition is needed: The criteria concerning the duration of the principal comparison must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on the duration of the principal comparison with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification are internally designed — an internal adaptation for the duration of the principal comparison.

Related sources S23 S24

N10 · Have Ma’s random sequence, allocation concealment, and blinding procedures been verified?

Current findings: Ma’s study is preserved as a randomized, double-blind, four-arm trial. The current summary does not contain details of sequence generation, allocation concealment, or blinded assessment, or complete information on baseline balance.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The design type was verified, but the detailed allocation and measurement procedures have not been verified.
Reason for missing information: The design type was verified as a randomized, double-blind, four-arm trial. The detailed procedures for sequence generation, allocation concealment, and blinded assessment, and complete information on baseline balance between arms, remain unverified.
Required materials and conditions: Ma’s random sequence, allocation concealment and blinding methods, and baseline table by arm.
Materials to obtain first: Ma’s random sequence, allocation concealment and blinding methods, and baseline table by arm.
Further research: Compare the methods and baseline table of the four-arm trial to distinguish the stated design from actual procedures, and retain the areas that cannot be verified.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify random sequence generation, concealment, blinded assessment, and baseline balance for the relevant IFB/IF comparison.
Why this condition is needed: The criteria concerning allocation and blinding must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on allocation and blinding with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 §8.1–8.2.3; internal application — an internal adaptation for allocation and blinding.

Related sources S23

N11 · Have actual adherence, rescue treatment, and total exposure in IFB/IF been verified?

Current findings: Shared iron and folate and the added B2 dose define the nominal comparison. Total dietary intake and exposure to all supplements are blank/unverified, and adherence and rescue-treatment information by arm could not be verified in the current summary either.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The nominal doses and shared treatment alone do not establish that actual exposure or changes by arm have been verified.
Reason for missing information: Actual intake, adherence, rescue treatment, changes to iron and folate, and total dietary and other-supplement exposure by arm in IFB/IF remain unverified. Nominal doses and shared treatment alone cannot verify actual exposure.
Required materials and conditions: Records by arm of intake/adherence, rescue treatment, changes to iron/folate, diet, and other supplements.
Materials to obtain first: Records by arm of intake/adherence, rescue treatment, changes to iron/folate, diet, and other supplements.
Further research: Review changes in administration and concomitant treatment over time, and compare the scope of analyses of the effect of assignment with that of analyses of the effect of actual intake.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link actual intake, deviations, changes in concomitant treatment, total dietary/supplement exposure by arm, and the methods used to handle these.
Why this condition is needed: The criteria concerning adherence and changes in concomitant treatment must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on adherence and changes in concomitant treatment with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.3 and M08 §8.2.2–8.2.3; internal application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are internally designed — an internal adaptation for adherence and changes in concomitant treatment.

Related sources S23

N12 · Have the Hb measurement methods, units, time points, and assessment procedures in IFB/IF been verified?

Current findings: The selected endpoint is the between-group difference in the change in blood Hb concentration. Anemia prevalence was also reported, but it does not replace this question. The actual Hb assay, measurement schedule, and complete assessment procedures remain unverified.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The endpoint's identity is linked, but the original methods and tables needed to verify the actual measurement conditions are still required.
Reason for missing information: The endpoint of change in blood Hb concentration has been verified, but the actual Hb assay, units, baseline and final measurement schedule, and complete assessment procedures remain unverified. Anemia prevalence is not substituted for this outcome.
Required materials and conditions: Ma’s Hb assay methods, units, baseline/end-of-treatment measurement table, and information on blinded assessment.
Materials to obtain first: Ma’s Hb assay methods, units, baseline/end-of-treatment measurement table, and information on blinded assessment.
Further research: Compare the Hb measurement procedures with the time points and units in the results tables, and keep them separate from anemia prevalence or other laboratory values.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the actual assay methods, time points, baseline/end-of-treatment values, and assessment procedures for changes in blood Hb to the relevant result.
Why this condition is needed: The criteria concerning Hb measurement must be verified separately for this IFB versus IF question to avoid mixing results from other populations, combined formulations, or denominators.
Application exceptions: Do not fill gaps in unverified information on Hb measurement with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a and M03 §3.2.4; internal application — an internal adaptation for Hb measurement.

Related sources S23

N13 · Have the actual analysis population, adjustment, and definition of change for IFB versus IF been verified?

Current findings: The question concerns the between-group difference in Hb change, but the corresponding IFB/IF effect size and dispersion remain unverified. Because complete paired-data or adjustment inputs were unavailable, the original record of effect-size attempts (effect_size_attempts) also produced no new approximation. The actual ITT/PP population or model is not filled in.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The actual analytical definition for the principal comparison has not been verified, so it cannot be replaced with assignment counts or arithmetic from another comparison.
Reason for missing information: The IFB/IF analysis populations, such as ITT and PP, the adjustment model, and the actual definition of Hb change remain unverified. The required paired-data or adjustment inputs and the principal comparison's results table could not be verified either.
Required materials and conditions: The IFB/IF analysis plan, ITT/PP populations, adjustment model, definition of change, and original results tables.
Materials to obtain first: The IFB/IF analysis plan, ITT/PP populations, adjustment model, definition of change, and original results tables.
Further research: Compare the reported analysis with the plan and review the scope of the estimate, without turning a within-group rise into a between-group effect of adding B2.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the analytical definitions of the effect of assignment or adherence, ITT/PP, adjustment, and baseline/final values or change to the actual IFB/IF results.
Why this condition is needed: The conditions concerning the effect of interest and analysis must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on the effect of interest and analysis with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 §8.2.2, M15 §15.3.1; application for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet — an adaptation for this sheet concerning the effect of interest and analysis.

Related sources S23

N14 · Have the 366 participants assigned overall and the 91/93 assigned to the two arms been linked to the actual Hb analysis denominators?

Current findings: There were 366 participants assigned overall: IFB 91 and IF 93. The original descriptive total of 184 refers to assigned participants, not the endpoint analysis count (assigned_participants/not_analyzed_endpoint_n). The value field for the Hb analysis denominator is empty/unverified.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The assignment counts have been preserved, but they have not been linked to the corresponding Hb measurement and analysis counts (n) or to the flow of missing data.
Reason for missing information: The assignment counts of 366 overall, IFB 91, and IF 93 have been verified. The numbers with Hb measurements and included in analysis by arm, reasons for exclusion, and missing-data handling remain unverified; the historical total of 184 is not used as the Hb analysis denominator.
Required materials and conditions: Ma's IFB/IF participant flow diagram, measurement and analysis counts (n), reasons for exclusion, and table of missing-data handling.
Materials to obtain first: Ma's IFB/IF participant flow diagram, measurement and analysis counts (n), reasons for exclusion, and table of missing-data handling.
Further research: Compare the total across the four arms with the participant flow in the two comparison arms, and check that the original total of 184 participants is not used as the analysis denominator.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link recruitment → allocation to four arms → Hb measurement → analysis denominators, together with exclusions and missing-data handling, separately for IFB and IF.
Why this condition is needed: The conditions concerning allocation and analysis denominators must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on allocation and analysis denominators with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning allocation and analysis denominators.

Related sources S23

N15 · Has the between-group Hb effect size for IFB versus IF been verified?

Current findings: The IFB–IF Hb effect size and dispersion remain unverified in the currently accessible materials. EX denotes this verification limit; it does not mean an effect of 0 or that data are absent from the entire full text that could not be accessed.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The inputs needed to verify the effect value for the principal comparison of adding B2 alone are unavailable.
Reason for missing information: The materials needed to verify the original between-group Hb effect size, units, and definition of the estimate for IFB versus IF, which adds only B2, remain unverified. EX denotes the limits of current access; it does not mean an effect of 0 or that data are absent from the entire full text.
Required materials and conditions: Ma's Hb values by IFB/IF arm, between-group estimate, definitions, and original tables.
Materials to obtain first: Ma's Hb values by IFB/IF arm, between-group estimate, definitions, and original tables.
Further research: Compare the original results tables for the four arms, extract only the estimate for the principal IFB/IF comparison, and exclude values for the combination arm or prevalence.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify the original between-group Hb effect size, units, and definition of the estimate for the comparison that adds only B2 to the same iron and folate treatment.
Why this condition is needed: The conditions concerning the Hb difference from adding B2 alone must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on the Hb difference from adding B2 alone with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M08 §8.2.2, M15 §15.3.1; application for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning the Hb difference from adding B2 alone.

Related sources S23

N16 · Have the type of dispersion measure, CI, and criterion for an important difference for IFB/IF been verified?

Current findings: The IFB–IF Hb difference, dispersion, interval, and denominator remain unverified. The original CX is preserved, and the ±1.1 from another combination arm is not filled in as SD/SE or a CI. No arbitrary minimum sample size or important difference is created.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The original inputs for the precision of the principal comparison and the criterion for importance have not been verified.
Reason for missing information: The type of dispersion measure, analysis count (n), and CI for the principal IFB/IF effect, together with an evidence-based criterion for an important Hb difference, remain unverified. The ±1.1 from the IFAB combination arm is not substituted for the SD, SE, or CI of the principal comparison.
Required materials and conditions: Original information on the type of dispersion measure, CI, analysis count (n), and a justified important Hb difference for the principal IFB/IF comparison.
Materials to obtain first: Original information on the type of dispersion measure, CI, analysis count (n), and a justified important Hb difference for the principal IFB/IF comparison.
Further research: Compare the original table footnotes, analysis model, and intervals, and review the scope of interpretation by comparing them with the defined important difference.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify the type of measure, such as SD/SE, the analysis count (n), and CI for the principal estimate, together with a justified criterion for an important Hb difference.
Why this condition is needed: The conditions concerning dispersion and intervals must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on dispersion and intervals with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M15 §15.3.1–15.3.3; application for this sheet — an adaptation for this sheet concerning dispersion and intervals.

Related sources S23

N17 · Has 5.4±1.1 g/L been excluded from the effect of adding B2 alone?

Current findings: The abstract's 5.4±1.1 g/L is for IFAB versus IF, which adds both vitamin A and B2. The original correction excluded it from the effect of adding B2 alone and did not fill in an SD/SE designation absent from the abstract.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The original attribution of the combination-arm number and the unverified type of dispersion measure have been preserved in the current manuscript and correction.
Reason for missing information: The attribution of 5.4±1.1 g/L to IFAB versus IF, which adds A and B2 together, has been verified. The type of dispersion measure represented by ± remains unverified in the abstract, and the number is not repurposed as an effect value for B2 alone.
Required materials and conditions: Original tables and footnotes that correct the attribution of results to the combination or single-addition arm, or the type of measure represented by ±.
Materials to obtain first: Original tables and footnotes that correct the attribution of results to the combination or single-addition arm, or the type of measure represented by ±.
Further research: Compare the components and results of the four arms side by side, and verify the comparison arms and definition of dispersion for each number.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Attribute 5.4±1.1 g/L to IFAB versus IF, in which A+B2 are added together; do not repurpose it as an effect of B2 alone or as an identified type of dispersion measure.
Why this condition is needed: The conditions concerning attribution of the combination-arm value must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on attribution of the combination-arm value with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M03 §3.2.2–3.2.3; reverse-direction markers and adaptations of checks were designed for this sheet; M03 §3.2.3, M08 §8.2.2–8.2.3; application for this sheet — an adaptation for this sheet concerning attribution of the combination-arm value.

Related sources S23

N18 · Are Ma's Hb endpoint, time points, and analysis consistent with the prospective registration and plan?

Current findings: Ma's trial registration identifier field (nct) is empty, and the value field in the record of the registered primary endpoint and the value comparing the study's primary endpoint with this page's endpoint (study_primary_vs_page_endpoint.value) are also empty/unverified. The fact that Hb is a reported endpoint is not converted into designation as the registered primary (1st) endpoint.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Independent materials for cross-checking the plan and registration are unavailable, so concordance, nonregistration, or selective reporting cannot be established.
Reason for missing information: Independent cross-checking of Ma's registration identity, protocol, SAP, and the Hb endpoint's status, time points, analysis, and change history remains unverified. An empty nct field is not interpreted as confirmation of nonregistration or selective reporting.
Required materials and conditions: Ma's registration, protocol, SAP, change history, and original Hb results.
Materials to obtain first: Ma's registration, protocol, SAP, change history, and original Hb results.
Further research: Compare the status of Hb in the original plan with the actual IFB/IF report, leaving anything that cannot be cross-checked unverified.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Compare the reported information with the endpoint status, time points, and analysis specified in the registration, protocol, and SAP for the principal comparison.
Why this condition is needed: The conditions concerning registration and the analysis plan must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on registration and the analysis plan with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; application for this sheet — an adaptation for this sheet concerning registration and the analysis plan.

Related sources S23

N19 · Have Suprapto's between-group Hb values for B2 versus iron and folate been verified?

Current findings: Suprapto's study used alternating allocation and 5 mg for 60 days. The significant comparison in the abstract is the B2 arm versus the vitamin A arm; it does not establish an effect of B2 versus iron and folate. It is not directly pooled with Ma's randomized comparison of 1 mg for 2 months.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Although related materials on anemia in pregnancy are available, the between-group Hb values for the target comparison remain unverified in the current summary.
Reason for missing information: Suprapto's between-group Hb values, dispersion, CI, and actual analysis count (n) for B2 versus iron and folate remain unverified. The significant comparison of B2 versus vitamin A presented in the abstract does not verify the target comparison.
Required materials and conditions: Suprapto's arm composition, Hb results for B2 versus iron/folate, dispersion/CI, and analysis count (n).
Materials to obtain first: Suprapto's arm composition, Hb results for B2 versus iron/folate, dispersion/CI, and analysis count (n).
Further research: Compare the original results by arm with the significant comparison in the abstract, distinguishing B2 versus vitamin A results from results versus iron and folate.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the actual comparison values and intervals for B2 versus iron and folate, with alternating allocation and 5 mg/60 days, to the corresponding population and denominators.
Why this condition is needed: The conditions concerning Suprapto's comparison values must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on Suprapto's comparison values with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M08 §8.1–8.2.3; application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning Suprapto's comparison values.

Related sources S24

N20 · Have the reasons by arm for excluding 19 of 103 participants and the Hb analysis denominators been verified?

Current findings: Preserve the alternating allocation of 103 participants, the exclusion of 19 from analysis, and the originally reported 18.4%. The check of 18.4% in the original numerical-check record (numeric_checks) is a historical record and is not recalculated in this work. Hb denominators by arm and reasons for exclusion remain unverified.
Verification status: Partly verified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The overall assignment count and the reported number excluded are available, but the analysis flow by arm has not been verified.
Reason for missing information: The alternating allocation of 103 participants, the exclusion of 19, and the originally reported 18.4% have been preserved. Allocation, exclusion, and Hb analysis flow by arm, reasons for exclusion, and missing-data handling remain unverified.
Required materials and conditions: Suprapto's allocation/exclusion/analysis flow by arm, reasons for excluding 19 participants, and missing-data handling.
Materials to obtain first: Suprapto's allocation/exclusion/analysis flow by arm, reasons for excluding 19 participants, and missing-data handling.
Further research: Review the original flow diagram to verify the distribution by arm of the 19 excluded participants and the originally reported 18.4%; do not generate an analysis count (n) by totaling the remaining participants.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the total assigned by alternating allocation, reasons for exclusion by arm, actual Hb analysis counts (n), and handling methods.
Why this condition is needed: The conditions concerning Suprapto's exclusion flow must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on Suprapto's exclusion flow with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations for individual study designs were designed for this sheet; M08 §8.1–8.2.3; application for this sheet — an adaptation for this sheet concerning Suprapto's exclusion flow.

Related sources S24

N21 · Do the S10 protocol and the S11 results citation belong to the same RIBOFEM study family?

Current findings: The study identifier (study_id) for S10 and S11 is RIBOFEM. S10 is a protocol involving healthy women with low B2 status, and S11 is the results citation for the same study family, with full-text effect values unverified. The 2 reports are not newly counted as 2 trials.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The original study identifier (study_id) and report role (role) specify the shared study family and the difference in report types.
Reason for missing information: The linkage of the S10 protocol and the S11 results citation to the same RIBOFEM study family has been verified. The actual full-text effect values for S11 remain unverified, and the two reports are not counted as two independent trials.
Required materials and conditions: Original bibliographic and registration materials that correct the identity relationship between the RIBOFEM protocol and results.
Materials to obtain first: Original bibliographic and registration materials that correct the identity relationship between the RIBOFEM protocol and results.
Further research: Cross-check the protocol/results linkage using registration, authorship, and recruitment information; do not count reports from the same study family as separate trials.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the preserved study identifier (study_id) and relationships, so that the protocol and results reports are not counted as new independent trials.
Why this condition is needed: The conditions concerning RIBOFEM as one study family must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on RIBOFEM as one study family with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning RIBOFEM as one study family.

Related sources S10 S11

N22 · Have the healthy women with low B2 status and the Hb assumptions for sample-size planning been excluded from observed treatment effects?

Current findings: RIBOFEM involves healthy young women with low B2 status. The Hb difference used for sample-size planning was not used as an observed treatment effect, and no unverified numerical effect values for S11 were created.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The exclusion boundaries for the population, design assumptions, and unverified results were verified in the preserved original results/bibliographic records.
Reason for missing information: The boundary that prevents RIBOFEM's population of healthy women with low B2 status and Hb assumptions for sample-size planning from being repurposed as treatment effects for anemia in pregnancy has been verified. The actual numerical effect values for S11 remain unverified.
Required materials and conditions: Original materials that correct the attribution of RIBOFEM's actual results, population, and design assumptions.
Materials to obtain first: Original materials that correct the attribution of RIBOFEM's actual results, population, and design assumptions.
Further research: Compare the protocol assumptions with the results tables to separate the Hb difference used for planning from observed values, and reassess the direct relevance of the population.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Do not use RIBOFEM's selection of healthy women and sample-size planning assumptions as actual IFB/IF treatment effects in anemic pregnant women.
Why this condition is needed: The conditions concerning healthy women and design assumptions must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on healthy women and design assumptions with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.1; detailed population conditions were designed for this sheet; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to individual questions were designed for this sheet; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses was designed for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning healthy women and design assumptions.

Related sources S10 S11

N23 · Has the same IFB/IF question been replicated in a separate independent study family?

Current findings: The original R1 refers to Ma's decisive trial supporting the principal comparison. Suprapto's different dose and alternating allocation, and RIBOFEM's different population and reports from the same study family, were not verified as independent replications of the exact principal comparison.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Independent replication of the exact add-on question has not been verified in this input, and the number of reports is not substituted for the number of replications.
Reason for missing information: It remains unverified whether the principal IFB/IF comparison has been replicated in a separate independent study family with the same population, addition of B2 alone, dose, duration, and Hb analysis conditions. The number of related reports is not substituted for direct replication.
Required materials and conditions: Population, product, dose, duration, IFB/IF Hb results, and study-family linkage information for an independent trial.
Materials to obtain first: Population, product, dose, duration, IFB/IF Hb results, and study-family linkage information for an independent trial.
Further research: Compare distinct study families and comparison conditions to assess whether reports with other doses/designs or healthy women are exact replications.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link actual results from an independent study family that is eligible in terms of the same population, addition of B2 alone, duration/dose, and Hb analysis.
Why this condition is needed: The conditions concerning direct replication must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on direct replication with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is an application for this sheet; M04 §4.6.1–4.6.2, M15 §15.3.1; application for this sheet — an adaptation for this sheet concerning direct replication.

Related sources S23 S24 S10 S11

N24 · Have funding, product provision, and author interests been verified for each relevant report?

Current findings: The funding information for the 4 evidence entries is preserved as unverified or not used in this page's grade. Distinguish the original treatment under I1/precedent 29 from actual verification of independent funding.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The original I1 axis alone does not verify funding, product provision, or conflicts of interest (COI) for each report.
Reason for missing information: The actual declarations of research funding, product provision, and author and institutional interests for each Ma, Suprapto, and RIBOFEM report remain unverified. The original I1 treatment does not mean that independent funding has been verified.
Required materials and conditions: Original declarations of funding, product provision, and conflicts of interest (COI) for each Ma/Suprapto/RIBOFEM report.
Materials to obtain first: Original declarations of funding, product provision, and conflicts of interest (COI) for each Ma/Suprapto/RIBOFEM report.
Further research: Compare each report's declarations with institutional support and product provision, without concluding that unverified funding is independent funding or evidence of bias.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify the actual funding, provision, and author declarations for each report and its study-family relationships at the recorded source locations.
Why this condition is needed: The conditions concerning funding and interests must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified information on funding and interests with another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methods sections used in this pilot do not endorse all of these detailed items — an adaptation for this sheet concerning funding and interests.

Related sources S23 S24 S10 S11

N25 · Does this Hb question require a judgment on the optimal dose of 1 mg versus 5 mg?

Current findings: The Ma 1 mg and Suprapto 5 mg materials concern different study designs, populations, and comparison conditions. These differences are not used to judge the optimal dose or dose–response, and an optimal-dose trial is not imposed on the current 1 mg question.
Verification status: Not applicable
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The optimal dose is a separate extension requirement outside the narrow principal question. The unverified status of direct comparison data remains recorded in the observations.
Reason for missing information: The optimal dose is not applicable to the current narrow question of adding 1 mg. Ma 1 mg and Suprapto 5 mg have not been verified as a direct dose comparison in the same population, and no judgment is made about the optimal dose or dose–response.
Required materials and conditions: If a separate dose comparison is reviewed: a direct randomized comparison of doses in the same population, with its plan and results.
Materials to obtain first: If a separate dose comparison is reviewed: a direct randomized comparison of doses in the same population, with its plan and results.
Further research: If the extended question is approved, review a randomized comparison of doses in the same population with Hb and harms predefined for each dose.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Preserve the current question of adding 1 mg, and do not remove that narrow question because a separate dose comparison is unavailable.
Why this condition is needed: The conditions concerning an extension to the optimal dose must be checked separately for this IFB versus IF question, so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Proof of the optimal dose is not imposed as a requirement for the narrow question of adding 1 mg.
Referenced methods: M03 §3.2.1–3.2.4; details concerning dose, persistence, and effect modification were designed for this sheet — an adaptation for this sheet concerning an extension to the optimal dose.

Related sources S23 S24

N26 · Does this question require a judgment on persistence beyond 2 months or on postpartum effects?

Current findings: The original duration is 2 months, and long-term and postpartum persistence remain unverified. Do not add a long-term maintenance trial as a mandatory requirement for the narrow principal question covering 2 months.
Verification status: Not applicable
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Efficacy during maintenance or postpartum is a separate question outside the scope of the current comparison.
Reason for missing information: Long-term maintenance efficacy, efficacy after discontinuation, or postpartum efficacy is not applicable to the current 2-month comparison. These extended effects remain unverified and are distinguished from verification of the principal comparison's duration.
Required materials and conditions: If the question is extended to persistence: denominators and time points for Hb after treatment discontinuation, postpartum, and over the long term, together with separate plans and results.
Materials to obtain first: If the question is extended to persistence: denominators and time points for Hb after treatment discontinuation, postpartum, and over the long term, together with separate plans and results.
Further research: For an extended question, review designs that distinguish the end of treatment, discontinuation, and postpartum time points while tracking Hb and changes in the shared treatment.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Distinguish the principal 2-month comparison from separate questions about the long term, discontinuation, or the postpartum period.
Why this condition is needed: The conditions for an extension to postpartum effects and persistence must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not impose evidence of long-term maintenance as a requirement for the 2-month effect question.
Referenced methods: M03 §3.2.1–3.2.4; the details concerning dose, persistence, and effect modification were developed for this assessment — an adaptation for the extension to postpartum effects and persistence.

Related sources S23

N27 · Does the Hb question require evidence of benefit for maternal and fetal clinical events?

Current findings: Hb is the original surrogate laboratory endpoint, designated S. Do not extend it to confirmation of clinical-event prevention or safety, and do not impose a clinical-event trial on the Hb comparison itself.
Verification status: Not applicable
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The current single question concerns Hb change; benefit in clinical events is a separate extension. Unverified harms remain unverified under the following safety conditions.
Reason for missing information: Benefit in maternal/fetal clinical events is not applicable to the current question about Hb change. Do not extend the Hb endpoint to confirmation of clinical-event prevention; the unverified status of harm information is retained separately in N28·N29.
Required materials and conditions: If the question is extended to clinical events: definitions of maternal/fetal events, denominators, follow-up, and results of the planned comparisons.
Materials to obtain first: If the question is extended to clinical events: definitions of maternal/fetal events, denominators, follow-up, and results of the planned comparisons.
Further research: For an extended question, define maternal/fetal events as endpoints separate from Hb and review the relevant direct comparison and follow-up.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Separate the question about change in Hb values from questions about clinical events, quality of life, mortality, or birth outcomes.
Why this condition is needed: The conditions concerning Hb and clinical events must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not impose a clinical-event trial as a requirement for a question about the Hb value itself.
Referenced methods: M03 §3.2.4; limits on extensions were developed for this assessment; M03 §3.2.4, M15 §15.3.1–15.3.3; adaptations of outcomes to each question were developed for this assessment — an adaptation for Hb and clinical events.

Related sources S23

N28 · Have the definitions of adverse events and discontinuation, and the denominators for each IFB/IF arm, been verified?

Current findings: Adverse-event denominators by arm and long-term maternal/fetal outcomes remain unverified in the accessed materials. Do not derive a claim of safety, AE 0, or risk rates solely from the existence of a study in pregnant women or the allocation of 91/93 participants.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Harm collection, aggregation, and denominators cannot be verified from the current input.
Reason for missing information: For the same IFB/IF exposures, adverse-event definitions, collection methods, severity, discontinuations, numbers of participants with events and numbers of events, and denominators and follow-up by arm remain unverified. Do not derive a claim of safety, AE 0, or risk rates from the allocation of 91/93 participants.
Required materials and conditions: Ma IFB/IF harm-collection methods; tables of adverse events (AE), serious adverse events (SAE), and discontinuations; participant/event counts; and denominators and follow-up by arm.
Materials to obtain first: Ma IFB/IF harm-collection methods; tables of adverse events (AE), serious adverse events (SAE), and discontinuations; participant/event counts; and denominators and follow-up by arm.
Further research: Distinguish events from participants in the original harm tables, compare follow-up and discontinuations by arm, and do not convert unreported or unobtained data into 0 events.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify event/participant counts, systematic collection, severity, discontinuations, exposure and analysis denominators by arm, and duration.
Why this condition is needed: The conditions for collection of harms by arm must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified data on collection of harms by arm using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M19 §19.1.2–19.2.4; application developed for this assessment; M19 §19.1.2–19.2.4; detailed distinctions were developed for this assessment; M19 §19.2.2–19.2.4, M03 §3.2.3; application developed for this assessment; M19 §19.1.2–19.2.4, M04 §4.6.3; application developed for this assessment — an adaptation for collection of harms by arm.

Related sources S23

N29 · Have long-term maternal/fetal harms and their timing in relation to exposure been verified?

Current findings: Long-term maternal/fetal outcomes remain unverified in the materials accessed in this work. No conclusion is drawn about safety across all doses and formulations, and this is not advice to stop or replace the shared iron–folate treatment.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: A short Hb comparison and pregnancy exposure alone cannot establish long-term safety or safety at other doses.
Reason for missing information: Actual exposure by stage of pregnancy, the timing of maternal/fetal event onset and discontinuation, and long-term follow-up results remain unverified. Do not establish long-term safety across all doses and formulations from a short Hb comparison.
Required materials and conditions: Exposure by stage of pregnancy; timing of maternal/fetal event onset and discontinuation; and long-term follow-up results.
Materials to obtain first: Exposure by stage of pregnancy; timing of maternal/fetal event onset and discontinuation; and long-term follow-up results.
Further research: Compare the stage of pregnancy with the exposure timeline, and review rare events and fetal outcomes separately with appropriate long-term follow-up.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Verify the stage of pregnancy, exposure/event onset, long-term maternal/fetal follow-up, and the actual scope of event reporting.
Why this condition is needed: The conditions for pregnancy and long-term safety must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified pregnancy and long-term safety data using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M19 §19.1.2–19.2.4; application developed for this assessment; harm questions by study design in M19 §19.2; details of temporal relationships were developed for this assessment; Chamgap's own limits on interpretation. This draws on M19 principles and is not an application of an official causality tool — an adaptation for pregnancy and long-term safety.

Related sources S23

N30 · Has Hb assay interference for this question been checked separately?

Current findings: The assay-interference value field (assay_interference.value) is empty, and no separate search was conducted. The absence of a separate systematic search does not establish the absence of interference. No additional external interference materials are being read in this work either.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: There is no record of a separate interference check having been performed, nor are the corresponding direct materials available.
Reason for missing information: B2 interference data for the actual Hb assay method and the scope of any separate systematic verification remain unverified. Do not turn the original absence of a separate search into a finding of no interference.
Required materials and conditions: The actual Hb assay method, data on testing for B2 interference, and search records for that scope.
Materials to obtain first: The actual Hb assay method, data on testing for B2 interference, and search records for that scope.
Further research: Compare the original assay with interference experiments, and review clinical Hb change and the possibility of analytical interference separately.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Distinguish the scope in which interference between the Hb assay method and B2 exposure was directly checked from areas that were not searched.
Why this condition is needed: The conditions for assay interference must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified assay-interference data using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for assay interference.

Related sources S23

N31 · Have drug interactions beyond the shared treatment been comprehensively verified?

Current findings: The drug-interaction field (drug_interactions) is empty, and no separate search was conducted; no separate comprehensive search of all drug interactions was performed. Total intake also remains unverified. Do not turn a nominal comparison of the shared iron–folate treatment into comprehensive verification of interactions.
Verification status: Unverified
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Identifying some concomitant treatments and verifying all drug interactions are different scopes of work.
Reason for missing information: Participants' complete concomitant drug and supplement use and data on specific interactions remain unverified. No separate comprehensive search was performed, and verification of the nominal identity of the shared iron–folate treatment does not substitute for that scope of work.
Required materials and conditions: Participants' complete lists of concomitant treatments; interaction/exposure data; and the original search scope.
Materials to obtain first: Participants' complete lists of concomitant treatments; interaction/exposure data; and the original search scope.
Further research: Compare concomitant use and actual exposure by arm, and review drug-interaction data and areas not searched separately.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the scope of verification and searches concerning concomitant drug/supplement use and interactions to the actual records.
Why this condition is needed: The conditions concerning limits on drugs and concomitant use must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified data on the limits concerning drugs and concomitant use using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; application developed for this assessment; M19 §19.1.2–19.2.4; application developed for this assessment; design considerations in M19 §19.2.2–19.2.4; detailed records of confounding were developed for this assessment — an adaptation for limits concerning drugs and concomitant use.

Related sources S23

N32 · Has reading the summaries in this work been distinguished from each report's historical access and from the fact that external materials have not been read in this work?

Current findings: This work involved actually reading the currently retained Korean/English (KO/EN) summaries. The original records for S23's indexed author abstract, S24's publisher abstract, S10's full-text HTML article, and S11's provided bibliographic extraction describe historical access. No access-date key exists for each citation record (citation), so these values are left empty; 2026-09-15 is distinguished as the original review date for the record as a whole. Access to the four external links was not attempted, and their materials were not read in this work.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Current reading, material types, historical access, and the absence of individual access dates were distinguished in accordance with the actual input schema.
Reason for missing information: The distinction between reading the locally retained summaries in this work, each report's historical access, and the fact that external materials have not been read in this work was verified. Individual access dates were absent from the original citation records (citation) and were preserved as empty values; none of the four external materials was directly read in this work.
Required materials and conditions: Corrections to each report's original access record/access date, link, and material type, or an actual material-acquisition event.
Materials to obtain first: Corrections to each report's original access record/access date, link, and material type, or an actual material-acquisition event.
Further research: Compare each report's citation record (citation) with its access history, link the summary viewer (reader) to the original location, and record any actual reading of external materials only as a separate event.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Record the actual reading of the currently retained summaries and, for each external material, that access was not attempted and the material was neither obtained nor read in this work; preserve historical access levels and original locations separately.
Why this condition is needed: The conditions for current and historical reading must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified data on current and historical reading using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: Material-collection and selection principles in M04 §4.5–4.6; the distinction between access and reading and the rules governing hyperlinks were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for current and historical reading.

Related sources S23 S24 S10 S11

N33 · Have the original search cutoff, corrections, and the scope of activities not performed in this work been stated explicitly?

Current findings: The original search cutoff and verification date (search_cutoff/verified_date) are 2026-09-15. This was not an exhaustive search of primary databases worldwide; the preservation conversion recorded here is dated 2026-10-05. The separate original search log (search_log), numerical evidence file (numeric_evidence), and report files were not opened, and no new search or calculation was performed.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: The scope of preservation checks and the activities not performed in this work were stated explicitly, without converting an absence of searching into 0 human studies.
Reason for missing information: The original cutoff date, the limited scope of searches and corrections, and the activities not performed during this conversion were stated explicitly. The separate search log (search_log), numerical evidence file (numeric_evidence), and report files, as well as the latest external literature, were neither read nor searched in this work.
Required materials and conditions: Original search and selection/correction logs, or a new official correction or full-text acquisition event.
Materials to obtain first: Original search and selection/correction logs, or a new official correction or full-text acquisition event.
Further research: Compare the original records of existing searches and corrections, and, if a new evidence review is separately approved, update them while recording dates, inclusion/exclusion decisions, and material levels.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Link the preserved search cutoff, revisions, and unverified items to the scope of new searches, full-text reading, and calculations not performed in this work.
Why this condition is needed: The conditions for the scope of searches and corrections must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified data on the scope of searches and corrections using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment; M04 §4.6.3, M15 §15.3.1–15.3.3; distinctions between statuses were developed for this assessment — an adaptation for the scope of searches and corrections.

Related sources S23 S24 S10 S11

N34 · Have the original C·46, all assessment axes, empty values, and historical arithmetic been preserved unchanged?

Current findings: Preserve the original C·46, B/S/R1/I1/EX/B1/CX, and the flag indicating whether there are no human studies (no_human_study=false). The original allocation total of 184 and arithmetic check of 18.4% were read as historical descriptive values; no new calculations, efficacy/safety scores, or condition-fulfillment rates were created.
Verification status: Met
Materials actually read: Summary read: the currently preserved KO/EN summaries were actually read. The related external original source material was not read in this work.
Why unverified: Preservation of all values in their original form throughout the source was distinguished from the new table's unscored status. This is neither independent clinical certification nor a new judgment.
Reason for missing information: Preservation of the original C·46, assessment axes, empty values, and historical arithmetic was verified. This verification is neither independent certification of the original clinical values nor a new efficacy or safety judgment, and no new clinical calculations were performed in this work.
Required materials and conditions: An official correction concerning the original judgment, assessment axes, empty values, arithmetic, or sources/identity.
Materials to obtain first: An official correction concerning the original judgment, assessment axes, empty values, arithmetic, or sources/identity.
Further research: Compare the complete original text before and after a correction, link only the changed identities/values to their supporting evidence and dates, and distinguish revision of the conditions version from a new judgment.
Remaining uncertainty: Original papers, registries, and older separate files outside the summaries preserved for this work were not read. An unverified status for this criterion is not interpreted as evidence of no effect.
Conditions for verification: Preserve the current original grade and score (grade/score), assessment axes, statuses, all values in their original form, and historical arithmetic separately from any new assessment of conditions.
Why this condition is needed: The conditions for the original judgment and historical values must be checked separately for this IFB versus IF question so that results from different populations, combination products, or denominators are not mixed.
Application exceptions: Do not fill gaps in unverified data on the original judgment and historical values using another study, allocation counts, or a different comparison in a title or abstract.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules were developed for this assessment; M04 §4.5, §4.6.3; limits on the current conversion of materials follow the user's scope and were developed for this assessment — an adaptation for the original judgment and historical values.

Related sources S23 S24 S10 S11