Ordinary thiamine (vitamin B1); actual salt not reported × Three-month Cockcroft–Gault-derived renal-function readout in early diabetic nephropathy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Independent claimWhich thiamine renal-function question is being presented in a single table?Required (selected renal-function question)	The original claim concerns the renal-function readout derived using Cockcroft–Gault at 3 months in early diabetic nephropathy. There are currently no subclaims; the question concerns the end mean with oral ordinary thiamine as a single active ingredient versus placebo/usual care. It was not extended to CKD overall, annual slope or long-term progression. S01	The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified.	The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months	Extract direct comparative results within this boundary, and keep eGFR slope and kidney-failure events as separate questions.
2	Partly verified	Full text not readStored summary read	N02 · Molecule and saltHave the actual salt and equivalent amount of single-ingredient ordinary thiamine been verified?Required (selected renal-function question)	Ordinary thiamine is the trial's sole active ingredient, and the actual salt is not reported. Manufacturing origin, manufacturer, excipients and free-thiamine equivalent are also unverified. Do not identify the trial product from the authorized thiamine hydrochloride product in S13 or benfotiamine in S09. S01 S09 S13	The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.	Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent	Verify identity against the original product and manufacturing/ingredient records, and review other salts and derivatives separately.
3	Conflicting information	Full text not readStored summary read	N03 · Physical dosage formHas the difference between the capsule and tablet descriptions in the original article been resolved?Required (selected renal-function question)	The current Korean record describes capsules in the S01 abstract and tablets in the methods, leaving the actual physical dosage form in conflict. The boundary of ordinary thiamine as a single active ingredient is separate from this unresolved wording. S01	Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.	Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials	Compare the original article's dosage-form descriptions with product records to clarify the physical dosage form in the same trial.
4	Partly verified	Full text not readStored summary read	N04 · Nominal and actual doseHave the nominal dose and the actual dosing schedule and adherence been distinguished?Required (selected renal-function question)	In S01, the nominal 3×100 mg/day and total 300 mg/day are previously verified values. However, a divided schedule of 3 times a day, meal timing, the actual adherence rate and free-thiamine equivalent remain unverified. Do not turn the nominal amount into an individual dosing recommendation. S01	The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.	Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent	Link the original intake and adherence records to product identity to extract actual exposure.
5	Partly verified	Full text not readStored summary read	N05 · Treatment and observation durationHave 3 months of treatment and 2 months of observation after discontinuation been separated?Required (selected renal-function question)	The selected main time point and treatment duration are 3 months. The 2 months of observation after discontinuation in the existing manuscript are separate; they are not combined with the end mean at 3 months and called 5 months of treatment or a sustained effect. S01	The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.	Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation	Extract actual renal-function results at each visit and post-discontinuation time point separately to retain the time boundaries.
6	Partly verified	Full text not readStored summary read	N06 · Actual populationHave the actual participants' diabetes, microalbuminuria and CKD stage been verified?Required (selected renal-function question)	S01 is a pilot trial in adults aged 35–65 years with type 2 diabetes and persistent microalbuminuria, with 40 participants. CKD stage is unspecified, and this is not the same population as dialysis, transplant or nondiabetic CKD populations. S01	Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.	Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage	Compare original eligibility criteria, baseline distributions and stage data, and review direct comparisons by stage/cause separately.
7	Partly verified	Full text not readStored summary read	N07 · Nutritional statusCan correction of deficiency be distinguished from additional supplementation in nondeficient participants?Required (selected renal-function question)	The retained manuscript contains both low plasma thiamine and indicators of adequate dietary intake. It did not classify everyone as deficient or replete. For the analysis exclusion of 1 participant with very high baseline thiamine and possible prior supplementation, the arm and the extent of applicability to GFR remain unverified. S01	Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.	Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status	Link nutritional-status definitions and analyses by status to actual renal-function denominators.
8	Partly verified	Full text not readStored summary read	N08 · Comparator and background treatmentHas the actual balance of placebo and usual treatment been verified?Required (selected renal-function question)	The comparator is placebo with usual diabetes/blood-pressure treatment. The current manuscript explicitly notes imbalances in background treatment, including insulin. Changes and rescue treatment by arm, and the adjusted contribution of thiamine, have not been established. S01 S03	The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.	Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment	Compare baseline/follow-up differences in concomitant treatment and their impact on analysis against the original materials.
9	Partly verified	Full text not readStored summary read	N09 · Allocation and concealmentAt what level were randomization and concealment procedures reported?Required (selected renal-function question)	S01 reports a random-number table, central allocation and numbered opaque envelopes. The retained assessment also distinguishes this from an independent audit of concealment implementation. Do not describe the 40-person pilot trial as certified as a formal confirmatory trial. S01	The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.	Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records	Compare allocation, concealment and baseline-characteristic data for the outcome of interest.
10	Partly verified	Full text not readStored summary read	N10 · Blinding and adherenceHave reported blinding and actual adherence/blinding success been distinguished?Required (selected renal-function question)	Blinding of participants, care providers and assessors is reported, but the actual adherence rate and blinding success remain unverified. Do not erase this limitation solely because the creatinine-derived measure is objective. S01	Reported blinding and actual success/adherence have different levels of verification.	Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm	Link data on actual blinding, adherence and changes by arm to the original analysis.
11	Partly verified	Full text not readStored summary read	N11 · Renal-function measureHave the formula, units and measurement boundaries of the value labeled GFR been verified?Required (selected renal-function question)	The original article calls it GFR, but the selected value is the end mean derived using Cockcroft–Gault at 3 months, in mL/min. The table notes recorded at the time mention Cockcroft–Gault/Jaffé; the value was not recast as body-surface-area-adjusted eGFR or measured GFR. The current work checked the retained location and did not newly audit the original measurement procedures. S01	The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.	Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures	Check the table notes and original measurement/calculation procedures to extract results by the same measure and units.
12	Met	Full text not readStored summary read	N12 · Endpoint hierarchyHave the page's target and the original trial's primary endpoint been distinguished?Required (selected renal-function question)	GFR is this page's target, and the original trial's primary endpoint is urinary albumin. The retained primary_result also explicitly states that the page's target differs from the trial's primary endpoint. Do not transfer a reduction in urinary albumin to inhibition of renal-function deterioration. S01	The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified.	The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan	Compare the registry and plan with the reported endpoint hierarchy, keeping urinary-albumin and renal-function results separate.
13	Met	Full text not readStored summary read	N13 · Means and dispersion in the original tableHave the baseline and 3-month end means±SD been retained unchanged?Required (selected renal-function question)	The baseline means±SD in the retained original S01 table are thiamine 85±19 and placebo 93±23 mL/min. The 3-month end means±SD are 90±30 and 97±18 mL/min. These are all arm-specific marginal means and SD, distinct from change SD and between-group CI. Analyzed/completer denominators remain null. S01	The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified.	S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators	Extract the original table together with the analyzed denominator at each time point and the definition of dispersion.
14	Partly verified	Full text not readStored summary read	N14 · Descriptive difference and causal effectHave the historical end-mean difference and the adjusted effect been distinguished?Required (selected renal-function question)	The existing unadjusted end-mean difference is −7 mL/min. With baseline means of 85 versus 93, this value is not interpreted as a causal effect or harm. The originally reported between-group estimate, baseline-adjusted effect and CI are null, and no calculation was created in the current work. S01	The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.	Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval	Compare effect magnitude only when the original adjusted model, between-group estimate and analyzed denominators have been obtained.
15	Unverified	Full text not readStored summary read	N15 · Randomized and analyzed denominatorsHave the 20/20 allocation and actual GFR analyzed/completer denominators been distinguished?Required (selected renal-function question)	Randomization involved 40 participants, 20/20. Analysis exclusion of 1 participant with very high baseline/urinary thiamine and possible prior supplementation is reported, but the arm and scope of applicability to GFR analysis remain unverified. GFR analyzed/completer denominators were not filled in as 20/20 or 19/20. S01	The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.	Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion	Compare the original flow diagram and analysis exclusions with the arm-specific denominators in the GFR table.
16	Unverified	Full text not readStored summary read	N16 · Missing data and analysis populationsHave GFR missing data, analysis populations and change variance been verified?Required (selected renal-function question)	Beyond the exclusion of 1 participant, arm-specific GFR missing-data handling and analysis populations remain unverified. Paired-change SD and baseline–follow-up correlation are also null. Do not use arm-specific marginal SD as change SD or establish ITT without the original source. S01	Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.	ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation	Link the original analysis population, missing-data/sensitivity handling and change variance to the outcome of interest.
17	Unverified	Full text not readStored summary read	N17 · Precision and importanceHave the exact P, CI and clinical importance been verified?Required (selected renal-function question)	The exact GFR P, CI, adjusted effect and MCID are null. Intervals were not reconstructed merely because arm-specific SD are available. These data do not support saying that clinically important benefit has been excluded or harm established. S01	The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.	Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model	Obtain the original estimate, CI, exact P and endpoint-specific basis for importance to review the scope of interpretation.
18	Met	Full text not readStored summary read	N18 · Interpretation of nonsignificanceHas a nonsignificant result been kept from being recast as an effect of 0 or equivalence?Required (selected renal-function question)	The authors reported no statistically significant effect on GFR during treatment. The manuscript did not strengthen this to a true effect of 0, equivalence, exclusion of clinical benefit or exclusion of inhibition of long-term progression. It also retained the gap in exact effect magnitude. S01	The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.	Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit	Review the original nonsignificant results together with intervals/denominators, avoiding an inaccurate interpretation as an effect of 0.
19	Partly verified	Full text not readStored summary read	N19 · Trial families and overlapHave reports, mirrors and companion reports been kept from being summed as independent trials?Required (selected renal-function question)	For the locked 3-month CG result, the sole direct family at the time was TF01. Publisher PDF/HTML, PubMed and author uploads are mirrors, while S03/04 are correspondence. Participant-level overlap in the S05–08 companion reports is unresolved, so no additional replications or participants were counted. S01 S03 S04 S05 S06 S07 S08	Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.	TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results	Compare family/registry/report/result/participant relationships to separate independent comparisons from potential overlaps.
20	Partly verified	Full text not readStored summary read	N20 · Critical letter and replyHave the substantive content of the critical letter and the unread reply been distinguished?Required (selected renal-function question)	S03 is a critical letter on background treatment and urinary-albumin summaries/interpretation, not a correction, retraction or new trial. The body of the S04 reply was unread at the time. Do not assume that a difference of medians equals the median of individual changes or state that the authors' substantive response was verified. S03 S04	The role of the critique has been verified, but the actual arguments in the reply remain unverified.	S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions	Compare the full reply with the points in the original critique by endpoint, checking actual correction events separately.
21	Unverified	Full text not readStored summary read	N21 · Companion reports and cohortsHave the same participants and additional results in S05–S08 been verified?Required (selected renal-function question)	S05 risk-factor, S06 transketolase, S07 protein-marker and S08 enzyme reports are companion discovery materials. Some registry leads exist, but recruitment wording differs, so they are neither established as the same 40 participants nor counted as independent additional participants. Do not read the S08 repository upload date as the year of a new trial. S05 S06 S07 S08	Full texts, participant-level links and additional contributions to the direct CG result remain unverified.	Registration, recruitment, populations and denominators; participant/result links between reports	Compare full companion reports, recruitment/registration and denominators to verify cohort links.
22	Unverified	Full text not readStored summary read	N22 · Registration and plansHave a printed registration number and actual reading of the registry/plan been distinguished?Required (selected renal-function question)	S01 prints CTRI2008/091/000112. The official S15 lookup at the time did not obtain the actual registry record because of a human-verification barrier. Registration dates and comparisons of plans/analyses/hierarchy remain unverified; no conclusion of nonregistration is drawn. S01 S15	Beyond the number, the actual original registry and plan contents remain unread/unverified.	CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy	In an authorized update, link the actual registry/plan and change history to the outcome hierarchy.
23	Partly verified	Full text not readStored summary read	N23 · Funding and independenceHave the levels of verification of public funding and conflict-of-interest declarations been distinguished?Supplementary; required for claims of independence	S01 records public/nonprofit support from Pakistan's HEC, a Warwick doctoral programme and the British Heart Foundation, along with a declaration of no conflicts of interest. Product provision/involvement and an independent audit remain unverified. Do not turn declarations into independent replication or certification of absence of bias. S01	Reported funding/declarations are available, but product involvement and independent verification remain unverified.	Reported funding; product provision/involvement; author relationships; scope of independent verification	Compare original funding, product provision and relationships, and review independent replication separately.
24	Partly verified	Full text not readStored summary read	N24 · Adjacent CKD3 resultsWhat do the different stage, duration and eGFR change in S02 answer?Supplementary (adjacent comparison)	S02 is a study in type 2 diabetes and CKD3 lasting 24 weeks, with 35 participants allocated 18/17. Preserve median eGFR changes of 1.59 versus 1.78 mL/min/1.73m² and the existing difference of −0.19 and P=0.61. Actual route, adult age, salt/product and analyzed denominators/CI remain unverified within the abstract's scope. An annual slope or equivalence was not verified. S02	Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.	S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI	Verify actual exposure, change, denominators/intervals in the adjacent full text and review them as a separate question.
25	Met	Full text not readStored summary read	N25 · Bibliography and adjacent familiesHave S02 and S22 been kept from being counted as different trials?Required (selected renal-function question)	Preserve the S02 online date of 2025-06-12 and print publication record of 2026. The S22 KKU bibliographic entry refers to the same TF02 and is not an additional trial. TF02 concerns change in body-surface-area-adjusted eGFR over 24 weeks, distinct from direct replication of the CG end mean at 3 months. S02 S22	This verifies bibliographic/family and measure boundaries, not the adjacent effect.	Online/print dates, DOI/institutional bibliography and links to the same TF02 report	Retain links to the same DOI/report, and verify any new independent comparison separately.
26	Unverified	Full text not readStored summary read	N26 · Provenance of the review estimateHas the relationship between the review's 0.31 estimate and the original end means been verified?Required (selected renal-function question)	In the S12 review, GFR MD0.31 and CI[−4.51,5.13] do not directly correspond to the descriptive difference between the original end means of 90 versus 97. The possibility of a different estimand, change or additional data remains unresolved. They were not automatically judged to represent the same effect or a review error/conflicting information. S01 S12	The actual analysis/data provenance of the review estimate remains unverified.	S12 estimand, denominators, additional-data/change definitions and links to original results	Compare the review's extraction table, estimand and additional data with the original results.
27	Does not apply	Full text not readStored summary read	N27 · Other derivativesHas benfotiamine been transferred into a direct effect of ordinary thiamine?Supplementary (boundary for other derivatives)	S09 Alkhalaf2010 concerns benfotiamine, TF03. Preserve the access limitations for the primary abstract/full text at the time. Do not import its effects, safety or denominators into the ordinary-thiamine CG result at 3 months. S09	Because it is a different molecule, it does not meet the conditions of the locked direct comparison.	Distinctions between molecule/exposure, endpoints and trial families	Check the relevant original materials when separately reviewing a question about the derivative.
28	Does not apply	Full text not readStored summary read	N28 · Combination and dialysis dataHas the individual contribution been verified from combination products or multinutrient registry records?Supplementary (combination/dialysis boundary)	S10 concerns thiamine+folic-acid cognition data in maintenance hemodialysis. S18 NCT01473914 is a registry index record for multinutrient/trace-element supplementation. Neither is a direct CG comparison of single-ingredient ordinary thiamine in early diabetic nephropathy. S10 S18	The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.	Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results	For combination/dialysis questions, separately review the results and whether the individual contribution can be identified.
29	Does not apply	Full text not readStored summary read	N29 · Observational, acute and animal dataHave status associations, acute AKI and animal data been transferred into chronic oral effects?Supplementary (data boundary)	S19 concerns observational thiamine-status data in ESRD, S20 associations in critically ill patients with AKI, and S21 animal CKD transporter data. Do not count them as causal renal-function effects of chronic oral ordinary thiamine in humans or as additional direct families/participants. S19 S20 S21	The designs and populations/exposures differ, so these do not apply to the locked direct comparison.	Distinctions between population/design, exposure, endpoints and data roles	For each separate question, verify eligible direct materials and the scope actually read.
30	Partly verified	Full text not readStored summary read	N30 · Renal pharmacokineticsDo single-dose 100 mg data in ESRD answer chronic 300 mg safety?Supplementary; required for safety claims concerning repeated exposure	S11 is an abstract on pharmacokinetics in ESRD following a single oral dose of ordinary thiamine nitrate or benfotiamine, 100 mg, over 24 hours. It does not establish renal benefit, safety regarding accumulation, stage-specific doses or dialysis prescribing for chronic 300 mg ordinary thiamine. S11	Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.	S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms	Separately verify pharmacokinetic/harm data for the same molecule, stage and repeated exposure.
31	Partly verified	Full text not readStored summary read	N31 · Separate authorized productHas the identity of the S13 SmPC product and the trial product been established as the same?Supplementary (product/safety context)	S13 is the Flamingo UK thiamine hydrochloride 100 mg SmPC, PL43461/0038. Preserve the historical update record of 2025-09-08 and text revision of 2025-02-18. Do not use this product to identify the salt, manufacturer, excipients or stage-specific dose in S01. S01 S13	Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified.	Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product	Verify the relationship between the actual trial product and the authorized product, and the version/warnings.
32	Partly verified	Full text not readStored summary read	N32 · Official nutrition information and interactionsDoes the absence of an established UL mean unlimited safety?Supplementary; required for safety claims	Do not interpret the absence of an upper intake level in S14 NIH ODS as unlimited safety. Preserve the locations of the medication explanations for Furosemide and fluorouracil, but do not create incidence rates or high-dose CKD prescriptions. No UL does not mean unlimited safety. S14	Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.	Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population	Compare official explanations separately with harms for the actual exposure/population concerned.
33	Unverified	Full text not readStored summary read	N33 · Harms and event denominatorsHave denominators for adverse reactions, serious events and discontinuations been verified?Supplementary; required for safety claims	AE/SAE, discontinuations due to adverse reactions and exact exposure denominators/duration in the selected oral trial remain unverified. Do not describe insufficient reporting as 0 events or as certification of individual safety. Do not transfer parenteral reactions into oral incidence rates. S01 S11 S13 S14	Arm-specific harm events, exposure and collection/discontinuation data remain unverified.	Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation	Verify arm-specific harm collection, denominators/duration and discontinuations for the same oral regimen.
34	Unverified	Full text not readStored summary read	N34 · Long-term and stage-specific safetyHave long-term accumulation and doses for special populations/by stage been verified?Supplementary; required for those extension claims	Direct data on long-term high-dose CKD safety, accumulation, doses by kidney-disease stage and special populations/concomitant use remain unverified. Do not combine the mean at 3 months, single-dose ESRD pharmacokinetics and a separate authorized product into long-term/optimal-dose prescribing. S01 S11 S13 S14	Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.	Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use	For extension questions, review harms and direct dose comparisons for the same molecule, stage and repeated exposure.
35	Does not apply	Full text not readStored summary read	N35 · Long-term progression and eventsDoes the 3-month CG readout answer questions about annual slope or kidney-failure events?Supplementary; required for claims about long-term events	The annualized_slope for the original 3-month CG end mean is null. Do not extend a reduction in urinary albumin or this readout into preventing dialysis, kidney failure or death, or slowing long-term progression. These events differ from the currently selected endpoint. S01 S02	This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.	Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure	For a long-term-progression question, review direct endpoints and adequate follow-up/denominators separately.
36	Unverified	Full text not readStored summary read	N36 · Unacquired registry leadHas the actual body of NCT06322212 been read?Required (selected renal-function question)	For S17 NCT06322212, the structured body was not obtained at the time because access yielded a JavaScript shell/API failure. Do not read CKD background descriptions as actual eligible populations/results or add eligible families/participants. S17	The actual registry body, eligibility/exposure and results remain unverified.	Actual structured registry body; eligibility/exposure; results/status; original change history	In an authorized update, verify the actual registry body and results/changes to reconsider the boundaries.
37	Partly verified	Full text not readStored summary read	N37 · Search and correction scopeHave search attempts been distinguished from completed native-database/correction reviews?Required (selected renal-function question)	The original cutoff date is 2026-09-16, and the 41 general-web searches at that time were not an exhaustive native PubMed search. The S23 native query returned no result set because of an internal error, and S16 viewed only the Thai registry homepage. No external search, correction/retraction lookup or reading of the old qa/corrections.json was performed in the current work. S15 S16 S23	Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.	Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions	In a separately authorized update, record actual search/registry/correction results and the scope of failures.
38	Met	Full text not readStored summary read	N38 · Original verdict and document qualityAre the existing D30 and document A being read as new clinical verification?Required (selected renal-function question)	Preserve the existing D, 30 and Caution and the original verdict, including axes such as E0/CX. Document A and self-checking by the same model are not independent clinical review or efficacy/safety certification. The current work converted stored materials into a table; no new grade, score or clinical calculation was created. S01	This verifies the distinction between original values and document roles, not a new clinical verdict.	Original grade/score; document assessment; verification actor; actual scope of conversion	If a new evidence event is authorized, link a separate version/decision to the clinical evidence.
39	Met	Full text not readStored summary read	N39 · Reading, identity and updatesAre summary links and past publication metadata being read as verification of current original sources/publication?Required (selected renal-function question)	Preserve the current 3121 identity, original URL, cutoff/publication and deployment metadata of 2026-09-16, and revision history. What was read in the current work was the local stored summary; historical access differs among the 23 provenance entries. All local_original_copy values are null. Summary links connect to retained locations/values/SHA, without claiming current external full-text reading or public publication in the current work. S01 S02 S03 S04 S11 S12 S13 S14	This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.	ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links	When new materials arrive, preserve everything before changes and reconsider the relevant rows, materials, criteria version and change decision.

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39 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-04
Original evidence cut-off: 2026-09-16
Scope actually checked: Stored Korean and English manuscripts and case-specific criteria and application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of an up-to-date clinical literature search.
Population: Age 35–65 years, type 2 diabetes and persistent microalbuminuria; CKD stage and uniform deficiency status unverified
Ingredient, formulation and route: Thiamine as the single active ingredient in the trial; salt not reported; conflicting capsule/tablet descriptions
Dose: Nominal 3×100 mg/day; 300 mg/day; free-thiamine equivalent unverified
Comparator: Placebo + usual diabetes/blood-pressure treatment; imbalance in background treatment, including insulin, explicitly noted
Measured outcome: End mean of the value labeled GFR derived using Cockcroft–Gault at 3 months (mL/min); unadjusted descriptive between-group difference
Duration: Treatment duration and main time point: 3 months; the additional 2 months of observation after discontinuation are separate
Questions outside this scope: Urinary albumin, annual slope/long-term events, CKD overall, other derivatives/combinations/dialysis, and observational/acute/animal data are not combined as direct effects.

Evidence and sources

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

S01 · Rabbani et al. High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study

Source

Material type: Direct pilot RCT · Historical full text/PDF, 5 pages
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is one trial. Author uploads, publisher HTML, PDF and PubMed are not counted as separate replications. Salt and exact analyzed denominators remain unverified. Thiamine 90±30, placebo 97±18 mL/min; unadjusted end-mean difference −7 mL/min. No significant improvement was reported, and exact CI and P remain unverified. Randomized 20/20; the arm of the 1 participant excluded from analysis and GFR analyzed/completer denominators remain unverified. The only direct trial family for the locked endpoint; not extended to a causal effect, equivalence or inhibition of long-term progression.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article PDF/HTML Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S02 · Phrawong et al. Thiamine for Increasing Estimated Glomerular Filtration Rate in Type 2 Diabetes Mellitus with Chronic Kidney Disease Stage 3: A Randomized Controlled Trial

Source

Material type: Adjacent CKD3 RCT · Historical publisher abstract/metadata/graphical abstract
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The route was not explicitly stated in the abstract, and adult age criteria, salt, composition, analyzed denominators and CI were not verified. This is a between-group difference in median changes at 24 weeks, not a slope. 1.59 versus 1.78 mL/min/1.73 m², difference −0.19, P=0.61; CI unverified. Randomized 18/17; analyzed/completer denominators unverified. Endpoint, time point and boundaries differ; not summed as a direct replication, and efficacy axes are not borrowed.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Publisher abstract, bibliography and graphical abstract Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S03 · Alkhalaf et al. Thiamine in diabetic nephropathy: a novel treatment modality?

Source

Material type: Critical letter · Historical HTML/PDF text
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is a critical letter, not a correction, retraction or new clinical trial. A difference of medians is not assumed to equal the median of individual changes.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Critical letter HTML/PDF Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S04 · Rabbani et al. Thiamine in diabetic nephropathy: a novel treatment modality? Reply to Alkhalaf A, Kleefstra N, Groenier KH et al.

Source

Material type: Authors' reply · Historical preview/bibliography
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The full reply was not read. Do not state that the authors' substantive response to the critique was verified.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Reply preview/repository bibliography Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S05 · Alam et al. Effect of High Dose Thiamine Therapy on Risk Factors in Type 2 Diabetics

Source

Material type: Companion risk-factor report discovered · Historical index/abstract
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: A potential companion report with the same investigators, dose and duration. Participant-level overlap was not verified, so it was not counted as an independent replication or additional participants.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article index/abstract Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S06 · Alam et al. Effect of high dose thiamine therapy on activity and molecular aspects of transketolase in Type 2 diabetic patients

Source

Material type: Companion enzyme report discovered · Historical abstract/registry index
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: Recruitment numbers are described differently from the 40-person trial, so it is not definitively merged as the same 40 participants. This is a registry-linked report with potential overlap, not counted as an independent replication of the renal-function endpoint.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article abstract/registry index Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S07 · Riaz et al. Effect of high dose thiamine on the levels of urinary protein biomarkers in diabetes mellitus type 2

Source

Material type: Companion protein-marker report discovered · Historical index
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article index excerpts Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S08 · Alam et al. thiamine / pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase report

Source

Material type: Companion enzyme report discovered · Historical search index (record unread)
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The repository upload time is not treated as the year of a new trial. The full text was not read and is not used as evidence for decisive facts.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Repository search index Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S09 · Alkhalaf et al. A Double-Blind, Randomized, Placebo-Controlled Clinical Trial on Benfotiamine Treatment in Patients With Diabetic Nephropathy

Source

Material type: RCT of a different derivative · Historical primary abstract
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article abstract Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S10 · Xie et al. A prospective, randomized, double-blind, placebo-controlled, multicenter study of thiamin plus folic acid in the treatment of cognitive impairment in patients undergoing maintenance hemodialysis

Source

Material type: Combination/dialysis cognition trial · Historical screening materials
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This concerns thiamine+folic acid, maintenance hemodialysis and a cognitive endpoint. It is not counted as a renal-function replication for single-ingredient ordinary thiamine.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article abstract/author's full-text copy Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S11 · Frank et al. Alteration of thiamine pharmacokinetics by end-stage renal disease (ESRD)

Source

Material type: Single-dose ESRD pharmacokinetics · Historical abstract
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is a study of a single oral dose of 100 mg thiamine nitrate or benfotiamine, with pharmacokinetics over 24 hours. It does not establish long-term CKD safety, dose adjustment or renal-function efficacy at 300 mg/day.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed article abstract Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S12 · Raval et al. Vitamin B and its derivatives for diabetic kidney disease

Source

Material type: Review · Historical HTML (discovery/estimate provenance unresolved)
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The review's GFR MD 0.31 and CI −4.51~5.13 do not directly match the original table's end means. The estimand and provenance of additional data remain unverified, so these were not promoted to estimates verified against the original study.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Review HTML Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S13 · Flamingo Pharma UK Ltd. Thiamine Hydrochloride 100 mg Tablets — Summary of Product Characteristics

Source

Material type: Separate authorized-product SmPC · Historical full text
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Authorized-product SmPC HTML Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S14 · NIH Office of Dietary Supplements. Thiamin — Fact Sheet for Health Professionals

Source

Material type: Official nutrition/safety explanation · Historical full text
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Official nutrition fact sheet HTML Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S15 · Clinical Trials Registry–India official portal

Source

Material type: CTRI access attempt · Actual registry record not obtained
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: A human-verification barrier in the search form prevented comparison of the actual registration date, primary endpoint and analysis plan. This does not mean that registration is absent.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
CTRI lookup screen/actual registry record Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S16 · Thai Clinical Trials Registry official portal

Source

Material type: Thai registry discovery · Homepage/search incomplete
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Thai registry homepage/search results Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S17 · ClinicalTrials.gov NCT06322212

Source

Material type: Unacquired NCT registry lead · Shell/API failure
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
NCT structured registry body Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S18 · ClinicalTrials.gov NCT01473914 — Trace Element Replenishment in Hemodialysis

Source

Material type: Combination registry lead · Historical index
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
NCT registry index Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S19 · Thiamine status in end-stage chronic kidney disease patients — PMID 30182293

Source

Material type: ESRD status observation discovered · Historical index
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: Observational nutritional-status data are not a causal renal-function effect of oral treatment.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Article bibliography/index Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S20 · Li et al. Associations between early thiamine administration and clinical outcomes in critically ill patients with acute kidney injury

Source

Material type: Critically ill AKI association discovered · Historical abstract
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Original article abstract Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S21 · Bukhari et al. thiamine transporter expression in experimental chronic kidney disease

Source

Material type: Animal CKD mechanism study discovered · Historical index
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Animal-study bibliography/index Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S22 · Khon Kaen University research publication catalogue — 2025

Source

Material type: Institutional bibliography · Same TF02 report
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is for bibliographic verification, not material that verifies route, salt or detailed results.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Institutional bibliography page Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

S23 · PubMed native query access attempt

Source

Material type: PubMed query attempt · Error/no result set
Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.
Findings recorded in the stored summary: This is not represented as a completed PubMed database search.
Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.
Study overlap and independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed search result set Material URL unverified	Unverified (no external lookup in the current work)	Access not attempted	Not read	Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries

Report counts versus independent study counts

The stored manuscript records 1 direct trial family and 40 randomized participants for this fixed question. These are report links in the stored manuscript. TF01 · Direct pilot RCT · Historical full text/PDF, 5 pages · This is one trial. Author uploads, publisher HTML, PDF and PubMed are not counted as separate replications. Salt and exact analyzed denominators remain unverified. (S01) / TF02 · Adjacent CKD3 RCT · Historical publisher abstract/metadata/graphical abstract · The route was not explicitly stated in the abstract, and adult age criteria, salt, composition, analyzed denominators and CI were not verified. This is a between-group difference in median changes at 24 weeks, not a slope. (S02) / TF01 · Critical letter · Historical HTML/PDF text · This is a critical letter, not a correction, retraction or new clinical trial. A difference of medians is not assumed to equal the median of individual changes. (S03) / TF01 · Authors' reply · Historical preview/bibliography · The full reply was not read. Do not state that the authors' substantive response to the critique was verified. (S04) / TF01-linked_unresolved · Companion risk-factor report discovered · Historical index/abstract · A potential companion report with the same investigators, dose and duration. Participant-level overlap was not verified, so it was not counted as an independent replication or additional participants. (S05) / TF01-linked_unresolved · Companion enzyme report discovered · Historical abstract/registry index · Recruitment numbers are described differently from the 40-person trial, so it is not definitively merged as the same 40 participants. This is a registry-linked report with potential overlap, not counted as an independent replication of the renal-function endpoint. (S06) / TF01-linked_unresolved · Companion protein-marker report discovered · Historical index · These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants. (S07) / TF01-linked_unresolved · Companion enzyme report discovered · Historical search index (record unread) · The repository upload time is not treated as the year of a new trial. The full text was not read and is not used as evidence for decisive facts. (S08) / TF03 · RCT of a different derivative · Historical primary abstract · Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page. (S09) / TF04 · Combination/dialysis cognition trial · Historical screening materials · This concerns thiamine+folic acid, maintenance hemodialysis and a cognitive endpoint. It is not counted as a renal-function replication for single-ingredient ordinary thiamine. (S10) / TF05 · Single-dose ESRD pharmacokinetics · Historical abstract · This is a study of a single oral dose of 100 mg thiamine nitrate or benfotiamine, with pharmacokinetics over 24 hours. It does not establish long-term CKD safety, dose adjustment or renal-function efficacy at 300 mg/day. (S11) / None · Review · Historical HTML (discovery/estimate provenance unresolved) · The review's GFR MD 0.31 and CI −4.51~5.13 do not directly match the original table's end means. The estimand and provenance of additional data remain unverified, so these were not promoted to estimates verified against the original study. (S12) / None · Separate authorized-product SmPC · Historical full text · This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients. (S13) / None · Official nutrition/safety explanation · Historical full text · The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing. (S14) / None · CTRI access attempt · Actual registry record not obtained · A human-verification barrier in the search form prevented comparison of the actual registration date, primary endpoint and analysis plan. This does not mean that registration is absent. (S15) / None · Thai registry discovery · Homepage/search incomplete · The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered. (S16) / None · Unacquired NCT registry lead · Shell/API failure · Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature. (S17) / None · Combination registry lead · Historical index · This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine. (S18) / TF06 · ESRD status observation discovered · Historical index · Observational nutritional-status data are not a causal renal-function effect of oral treatment. (S19) / TF07 · Critically ill AKI association discovered · Historical abstract · Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial. (S20) / TF08 · Animal CKD mechanism study discovered · Historical index · This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans. (S21) / TF02 · Institutional bibliography · Same TF02 report · This is for bibliographic verification, not material that verifies route, salt or detailed results. (S22) / None · PubMed query attempt · Error/no result set · This is not represented as a completed PubMed database search. (S23) This is not expanded into the total number of unique trials or the sum of participants across all adjacent materials. Verification of stored summaries is distinguished from nonreading of external original materials in the current work; report and family labels are not summed into total trial or participant counts.

Review criteria

Version 3121-ORAL-THIAMINE-CG-3M-1.0 · Criteria record date 2026-10-04. 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 · Which thiamine renal-function question is being presented in a single table?

Required materials and conditions: The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months
Conditions for verification: Retain the same independent question as the original /ko/effect and the actual PICO/time point, and explain the excluded questions.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not remove the unspecified CKD stage and unreported salt to present an apparently precise identity.
Why this condition is needed: Required to avoid combining renal-function values, urinary albumin, long-term progression and other preparations into a single efficacy status.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N02 · Have the actual salt and equivalent amount of single-ingredient ordinary thiamine been verified?

Required materials and conditions: Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent
Conditions for verification: Record the original trial's single active ingredient separately from the unverified chemical form/product identity.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Preserve the record of a single active ingredient, but do not fill in hydrochloride for the unreported salt.
Why this condition is needed: Required to avoid treating ordinary thiamine, hydrochloride, nitrate, benfotiamine and a separate authorized product as the same exposure.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N03 · Has the difference between the capsule and tablet descriptions in the original article been resolved?

Required materials and conditions: Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials
Conditions for verification: Preserve both descriptions and retain the conflict until verified against evidence about the actual product.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not infer a different trial or a difference in effects from the capsule/tablet discrepancy.
Why this condition is needed: Required to avoid silently harmonizing different dosage-form descriptions within the same original article.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N04 · Have the nominal dose and the actual dosing schedule and adherence been distinguished?

Required materials and conditions: Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent
Conditions for verification: Preserve the original nominal amount, and indicate gaps in the actual divided-dose schedule, meals, adherence and equivalence conversion.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: The retained 300 mg/day is an existing record, not a value calculated in the current work or a suggested dose for self-administration.
Why this condition is needed: Required to avoid automatically converting a nominal total amount into actual exposure or a schedule of 3 times a day.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N05 · Have 3 months of treatment and 2 months of observation after discontinuation been separated?

Required materials and conditions: Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation
Conditions for verification: Record the main time point/treatment and additional observation after discontinuation separately, and retain the scope for which direct results on maintenance are unavailable.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not establish a sustained effect solely from the existence of additional observation.
Why this condition is needed: Required to avoid turning end-of-treatment results into a sustained effect over 5 months or an annual slope.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N06 · Have the actual participants' diabetes, microalbuminuria and CKD stage been verified?

Required materials and conditions: Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage
Conditions for verification: Retain the verified age/disease/albuminuria together with the unverified stage, and indicate population differences.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not replace the currently unspecified CKD stage with an arbitrary stage 1/2/3.
Why this condition is needed: Required to avoid extending early diabetic nephropathy to CKD of all causes/stages or to dialysis/transplantation.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N07 · Can correction of deficiency be distinguished from additional supplementation in nondeficient participants?

Required materials and conditions: Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status
Conditions for verification: Distinguish verified status indicators from unverified uniform deficiency and separately attributable effects.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not confuse the analysis exclusion of 1 participant with high thiamine levels with uniform deficiency status across the whole population.
Why this condition is needed: Required to avoid harmonizing low plasma levels and indicators of dietary adequacy into a single deficient/nondeficient population.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N08 · Has the actual balance of placebo and usual treatment been verified?

Required materials and conditions: Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment
Conditions for verification: Distinguish placebo/usual care from actual imbalances and unverified changes/adjustments.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Compare the actual effect of interest and analysis without requiring every change in both arms to be identical.
Why this condition is needed: Required to avoid attributing differences in background treatment to thiamine's contribution.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N09 · At what level were randomization and concealment procedures reported?

Required materials and conditions: Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records
Conditions for verification: Link the level of allocation/concealment recorded in the original source to unverified implementation and baseline limitations.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Distinguish reported procedures from an independent audit of implementation, and do not call the pilot trial a formal confirmatory trial.
Why this condition is needed: Required to avoid claiming that allocation/concealment has been verified solely from the randomized-trial label.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N10 · Have reported blinding and actual adherence/blinding success been distinguished?

Required materials and conditions: Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm
Conditions for verification: Record whose blinding was reported separately from gaps concerning success/adherence.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not remove post-allocation deviations or changes in measurement/treatment on the grounds that the formula-derived value is objective.
Why this condition is needed: Required to avoid turning the double-blind label into actual balance of exposure or absence of bias.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N11 · Have the formula, units and measurement boundaries of the value labeled GFR been verified?

Required materials and conditions: Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures
Conditions for verification: Distinguish the formula, units and labeling from unverified measurement procedures/errors.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: What was read in the current work was the retained extraction and the location of the notes, not a new audit of measurement in the original PDF.
Why this condition is needed: Required to avoid turning a formula-derived value into measured GFR, body-surface-area-adjusted eGFR or an annual slope.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N12 · Have the page's target and the original trial's primary endpoint been distinguished?

Required materials and conditions: The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan
Conditions for verification: Keep the page's renal-function target separate from the trial's primary urinary-albumin endpoint, and indicate the gap in comparison with the original plan.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: GFR being this page's target does not mean it was preregistered as the trial's primary endpoint.
Why this condition is needed: Required to avoid automatically transferring a reduction in urinary albumin to improved renal function or inhibition of long-term progression.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N13 · Have the baseline and 3-month end means±SD been retained unchanged?

Required materials and conditions: S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators
Conditions for verification: Assign the original retained arm-specific means/SD to the correct time points/units, leaving gaps in analyzed denominators.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not fill in analyzed denominators from the 20/20 allocation or newly calculate the difference between the two time points.
Why this condition is needed: Required to avoid turning arm-specific baseline/end values and SD into change SD or causal-effect intervals.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N14 · Have the historical end-mean difference and the adjusted effect been distinguished?

Required materials and conditions: Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval
Conditions for verification: Record the historical unadjusted end-mean difference separately from the unverified adjusted causal effect/interval.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: −7 is existing descriptive arithmetic in the manuscript, not a value calculated, estimated or prescribed in the current work.
Why this condition is needed: Required to avoid interpreting a simple difference in end means with baseline differences as thiamine's causal effect or harm.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N15 · Have the 20/20 allocation and actual GFR analyzed/completer denominators been distinguished?

Required materials and conditions: Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion
Conditions for verification: Distinguish allocation from analysis/completion, and preserve unverified denominators as null.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: From the existing record of 1 participant excluded from analysis, do not infer that an arm had 19 participants.
Why this condition is needed: Required to avoid automatically using the 40 randomized participants as 40 analyzed participants or as 20/20 outcome denominators.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N16 · Have GFR missing data, analysis populations and change variance been verified?

Required materials and conditions: ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation
Conditions for verification: Retain the reported exclusion and unverified analysis/missing data and paired variance, without creating new estimates.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not label the analysis population ITT without the original source.
Why this condition is needed: Required to avoid reconstructing missing-data handling or change CI from known marginal SD and randomized numbers.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N17 · Have the exact P, CI and clinical importance been verified?

Required materials and conditions: Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model
Conditions for verification: Link the original intervals/importance criteria, or indicate why interpretation is not possible.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not propose arbitrary numbers for sample size, duration or the minimum important difference.
Why this condition is needed: Required to avoid concluding an effect of 0, exclusion of clinical benefit or equivalence from the word nonsignificant alone.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N18 · Has a nonsignificant result been kept from being recast as an effect of 0 or equivalence?

Required materials and conditions: Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit
Conditions for verification: Preserve the reported direction together with uncertainty, distinguishing them from a true effect of 0, equivalence or exclusion of benefit.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Retain the record of nonsignificance, but do not use it to assign a new efficacy/safety grade.
Why this condition is needed: Required to avoid strengthening verified nonsignificant results into definitive favorable or unfavorable conclusions.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N19 · Have reports, mirrors and companion reports been kept from being summed as independent trials?

Required materials and conditions: TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results
Conditions for verification: Distinguish verified families from provisional links, and preserve only their contributions to the direct locked result.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not turn unverified participant overlap in companion reports into confirmation of either the same cohort or a different trial.
Why this condition is needed: Required to avoid counting publisher/PubMed/author mirrors and companion analyses as independent replications/participants.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N20 · Have the substantive content of the critical letter and the unread reply been distinguished?

Required materials and conditions: S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions
Conditions for verification: Keep the scope of the verified critique separate from that of the unread reply.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not automatically transfer the issue concerning urinary-albumin medians to an error in the GFR result.
Why this condition is needed: Required to avoid claiming that the authors' substantive reply was read or turning correspondence into a new trial/correction.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N21 · Have the same participants and additional results in S05–S08 been verified?

Required materials and conditions: Registration, recruitment, populations and denominators; participant/result links between reports
Conditions for verification: Separate verified links from unverified participant-level overlap.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not establish that all of the same 40 participants were included solely from a shared registry lead.
Why this condition is needed: Required to avoid adding companion analyses as new participants or direct replications.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N22 · Have a printed registration number and actual reading of the registry/plan been distinguished?

Required materials and conditions: CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy
Conditions for verification: Record the reported number, actual failure/nonreading and gaps in the prespecified hierarchy.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not use an access barrier as evidence of nonregistration.
Why this condition is needed: Required to avoid turning a printed number into comparison with the entire registry record or verification of the prespecified hierarchy.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N23 · Have the levels of verification of public funding and conflict-of-interest declarations been distinguished?

Required materials and conditions: Reported funding; product provision/involvement; author relationships; scope of independent verification
Conditions for verification: Retain reported declarations together with gaps in product involvement/independent verification.
Requirement and applicability: Supplementary; required for claims of independence
Application exceptions: Do not automatically exclude results or establish absence of bias solely from funding.
Why this condition is needed: Required to avoid turning reported declarations into an independent audit of implementation or replication.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N24 · What do the different stage, duration and eGFR change in S02 answer?

Required materials and conditions: S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI
Conditions for verification: Indicate the scope of the adjacent abstract and the unverified exposure/denominators and precision.
Requirement and applicability: Supplementary (adjacent comparison)
Application exceptions: Do not fill in analyzed denominators from the randomization of 35 participants, 18/17.
Why this condition is needed: Required to avoid transferring results with a different measure and duration into direct replication of the 3-month CG result.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N25 · Have S02 and S22 been kept from being counted as different trials?

Required materials and conditions: Online/print dates, DOI/institutional bibliography and links to the same TF02 report
Conditions for verification: Distinguish the bibliography of the same TF02 report and its different measure/duration relative to the locked question.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not arbitrarily harmonize the 2025 online and 2026 print publication years into a single year.
Why this condition is needed: Required to avoid adding an institutional bibliographic entry as an independent replication.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N26 · Has the relationship between the review's 0.31 estimate and the original end means been verified?

Required materials and conditions: S12 estimand, denominators, additional-data/change definitions and links to original results
Conditions for verification: Retain the unverified link between the review's MD/CI and the original end means.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not declare a review error or conflicting information solely from the current difference.
Why this condition is needed: Required to avoid removing the possibility of a different analysis and automatically declaring an error or the same effect.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N27 · Has benfotiamine been transferred into a direct effect of ordinary thiamine?

Required materials and conditions: Distinctions between molecule/exposure, endpoints and trial families
Conditions for verification: Exclude the different derivative TF03 from the locked direct comparison.
Requirement and applicability: Supplementary (boundary for other derivatives)
Application exceptions: Retain the historical access limitations for S09.
Why this condition is needed: Required to avoid attributing results and safety for other derivatives to ordinary thiamine.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N28 · Has the individual contribution been verified from combination products or multinutrient registry records?

Required materials and conditions: Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results
Conditions for verification: Separate S10 combination cognition data and the S18 multinutrient registry record from the locked direct comparison.
Requirement and applicability: Supplementary (combination/dialysis boundary)
Application exceptions: Do not label a registry index record as completed results.
Why this condition is needed: Required to avoid turning combination results into the renal-function contribution of single-ingredient ordinary thiamine.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N29 · Have status associations, acute AKI and animal data been transferred into chronic oral effects?

Required materials and conditions: Distinctions between population/design, exposure, endpoints and data roles
Conditions for verification: Retain the design and population differences in S19–S21.
Requirement and applicability: Supplementary (data boundary)
Application exceptions: Do not expand the scope of index/abstract reading into full-text review.
Why this condition is needed: Required to avoid calling observational/acute/animal data a causal effect of chronic oral treatment in humans.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N30 · Do single-dose 100 mg data in ESRD answer chronic 300 mg safety?

Required materials and conditions: S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms
Conditions for verification: Separate the reported single-dose conditions from gaps concerning chronic harms/dose.
Requirement and applicability: Supplementary; required for safety claims concerning repeated exposure
Application exceptions: Do not harmonize single-dose nitrate/benfotiamine with the trial's 300 mg regimen whose salt was not reported.
Why this condition is needed: Required to avoid turning pharmacokinetic exposure into chronic efficacy or prescribing by kidney-disease stage.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N31 · Has the identity of the S13 SmPC product and the trial product been established as the same?

Required materials and conditions: Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product
Conditions for verification: Separate historical verification of the separate product from the unverified trial product.
Requirement and applicability: Supplementary (product/safety context)
Application exceptions: Do not turn an authorized product's doses/warnings into an individual CKD prescription.
Why this condition is needed: Required to avoid substituting a separate regulated product for the unreported trial product.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N32 · Does the absence of an established UL mean unlimited safety?

Required materials and conditions: Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population
Conditions for verification: Retain insufficient data and medication wording together with gaps in quantitative harms.
Requirement and applicability: Supplementary; required for safety claims
Application exceptions: Do not use general explanations as direct CKD trials or prescribing guidance.
Why this condition is needed: Required to avoid turning the absence of an established UL into high-dose CKD safety or unrestricted intake.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N33 · Have denominators for adverse reactions, serious events and discontinuations been verified?

Required materials and conditions: Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation
Conditions for verification: Retain unverified events/denominators and duration for the original harms data.
Requirement and applicability: Supplementary; required for safety claims
Application exceptions: Do not transfer reactions to injectable products into oral incidence rates.
Why this condition is needed: Required to avoid turning unverified quantitative harms into 0 events/0 risk.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N34 · Have long-term accumulation and doses for special populations/by stage been verified?

Required materials and conditions: Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use
Conditions for verification: Indicate the scope for which direct long-term/special-population data are unavailable.
Requirement and applicability: Supplementary; required for those extension claims
Application exceptions: Do not require all extension studies as prerequisites for the narrow question about the mean at 3 months.
Why this condition is needed: Required to avoid extending a short-term pilot trial into long-term/stage-specific prescribing.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N35 · Does the 3-month CG readout answer questions about annual slope or kidney-failure events?

Required materials and conditions: Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure
Conditions for verification: Do not claim annual slope and long-term events as direct locked results.
Requirement and applicability: Supplementary; required for claims about long-term events
Application exceptions: Distinguish the status of the current narrow numerical question from that of the long-term-event question.
Why this condition is needed: Required to avoid turning a surrogate renal-function readout and urinary albumin into patient-centered inhibition of progression.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N36 · Has the actual body of NCT06322212 been read?

Required materials and conditions: Actual structured registry body; eligibility/exposure; results/status; original change history
Conditions for verification: Distinguish the unacquired body and failed access from background/eligibility criteria.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not automatically promote a registry lead to an eligible direct comparison or completed results.
Why this condition is needed: Required to avoid calling a JavaScript shell and CKD background descriptions actual participants/results.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N37 · Have search attempts been distinguished from completed native-database/correction reviews?

Required materials and conditions: Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions
Conditions for verification: Distinguish the historical 41 general-web searches from incomplete native lookups and the current local conversion.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: No new search in the current work does not mean 0 studies or no recent corrections.
Why this condition is needed: Required to avoid turning search errors, homepages and existing routes into exhaustive searches or current correction reviews.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N38 · Are the existing D30 and document A being read as new clinical verification?

Required materials and conditions: Original grade/score; document assessment; verification actor; actual scope of conversion
Conditions for verification: Preserve the original D30/Caution and document/self-checking records as historical values.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not use the current table's statuses/counts as a new efficacy score.
Why this condition is needed: Required to separate document self-checking from clinical/safety certification.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

N39 · Are summary links and past publication metadata being read as verification of current original sources/publication?

Required materials and conditions: ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links
Conditions for verification: Link to the exact stored summary, and indicate current nonreading of external materials and local nonpublication.
Requirement and applicability: Required (selected renal-function question)
Application exceptions: Do not use a local stored-summary SHA as the hash of an external PDF's original bytes.
Why this condition is needed: Required to distinguish reading retained stored summaries from external clinical originals/public publication in the current work.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.
Extent of review: From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work.

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

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

Referenced principle: Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.
Extent of review: From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work.

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

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

Referenced principle: Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.
Extent of review: From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work.

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.
Extent of review: From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work.

What the statuses mean

Partly verified: Some records are available, but gaps remain in actual exposure, population/comparator, denominators/intervals and original-source access.
Unverified: The necessary information/conditions cannot be established within the scope checked in the current work.
Review incomplete: Comparison/search of original materials was not performed within the authorized scope.
Not reported: A scope-limited status indicating that the item was not stated in the specific material/section read.
Inaccessible: Used only for materials where access was actually attempted and failed. Not assigned to clinical materials in the current work.
Insufficient eligible evidence: Used only when relevant studies within a defined scope have been reviewed and the evidence is insufficient to answer the conditions. Not applied exhaustively in the current work.
Not applicable: A specific exception under the applicability conditions. Not a substitute status for material that has not been read.
Conflicting information: An unresolved difference in dosage-form descriptions within the same trial. Differences in results from different analyses/measures are not automatically called conflicts.
Met: Verification of the specified preservation/distinction/linking conditions. This is not certification of clinical efficacy, reading of external full texts or individual safety.
Does not apply: A material/extension boundary that does not apply to the direct conditions of the current locked question. Direct evidence is required for the corresponding separate claim.

Change history

2026-11-07 · Public page/material version 1.0

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

The stored-material review date (2026-10-04) and original evidence cut-off (2026-09-16) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which thiamine renal-function question is being presented in a single table?

Current findings: The original claim concerns the renal-function readout derived using Cockcroft–Gault at 3 months in early diabetic nephropathy. There are currently no subclaims; the question concerns the end mean with oral ordinary thiamine as a single active ingredient versus placebo/usual care. It was not extended to CKD overall, annual slope or long-term progression.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified.
Reason for missing information: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified.
Required materials and conditions: The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months
Materials to obtain first: The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months
Further research: Extract direct comparative results within this boundary, and keep eGFR slope and kidney-failure events as separate questions.
Remaining uncertainty: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified.
Conditions for verification: Retain the same independent question as the original /ko/effect and the actual PICO/time point, and explain the excluded questions.
Why this condition is needed: Required to avoid combining renal-function values, urinary albumin, long-term progression and other preparations into a single efficacy status.
Application exceptions: Do not remove the unspecified CKD stage and unreported salt to present an apparently precise identity.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N02 · Have the actual salt and equivalent amount of single-ingredient ordinary thiamine been verified?

Current findings: Ordinary thiamine is the trial's sole active ingredient, and the actual salt is not reported. Manufacturing origin, manufacturer, excipients and free-thiamine equivalent are also unverified. Do not identify the trial product from the authorized thiamine hydrochloride product in S13 or benfotiamine in S09.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.
Reason for missing information: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.
Required materials and conditions: Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent
Materials to obtain first: Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent
Further research: Verify identity against the original product and manufacturing/ingredient records, and review other salts and derivatives separately.
Remaining uncertainty: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.
Conditions for verification: Record the original trial's single active ingredient separately from the unverified chemical form/product identity.
Why this condition is needed: Required to avoid treating ordinary thiamine, hydrochloride, nitrate, benfotiamine and a separate authorized product as the same exposure.
Application exceptions: Preserve the record of a single active ingredient, but do not fill in hydrochloride for the unreported salt.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S09 S13

N03 · Has the difference between the capsule and tablet descriptions in the original article been resolved?

Current findings: The current Korean record describes capsules in the S01 abstract and tablets in the methods, leaving the actual physical dosage form in conflict. The boundary of ordinary thiamine as a single active ingredient is separate from this unresolved wording.
Verification status: Conflicting information
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.
Reason for missing information: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.
Required materials and conditions: Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials
Materials to obtain first: Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials
Further research: Compare the original article's dosage-form descriptions with product records to clarify the physical dosage form in the same trial.
Remaining uncertainty: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.
Conditions for verification: Preserve both descriptions and retain the conflict until verified against evidence about the actual product.
Why this condition is needed: Required to avoid silently harmonizing different dosage-form descriptions within the same original article.
Application exceptions: Do not infer a different trial or a difference in effects from the capsule/tablet discrepancy.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N04 · Have the nominal dose and the actual dosing schedule and adherence been distinguished?

Current findings: In S01, the nominal 3×100 mg/day and total 300 mg/day are previously verified values. However, a divided schedule of 3 times a day, meal timing, the actual adherence rate and free-thiamine equivalent remain unverified. Do not turn the nominal amount into an individual dosing recommendation.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.
Reason for missing information: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.
Required materials and conditions: Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent
Materials to obtain first: Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent
Further research: Link the original intake and adherence records to product identity to extract actual exposure.
Remaining uncertainty: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.
Conditions for verification: Preserve the original nominal amount, and indicate gaps in the actual divided-dose schedule, meals, adherence and equivalence conversion.
Why this condition is needed: Required to avoid automatically converting a nominal total amount into actual exposure or a schedule of 3 times a day.
Application exceptions: The retained 300 mg/day is an existing record, not a value calculated in the current work or a suggested dose for self-administration.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N05 · Have 3 months of treatment and 2 months of observation after discontinuation been separated?

Current findings: The selected main time point and treatment duration are 3 months. The 2 months of observation after discontinuation in the existing manuscript are separate; they are not combined with the end mean at 3 months and called 5 months of treatment or a sustained effect.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.
Reason for missing information: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.
Required materials and conditions: Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation
Materials to obtain first: Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation
Further research: Extract actual renal-function results at each visit and post-discontinuation time point separately to retain the time boundaries.
Remaining uncertainty: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.
Conditions for verification: Record the main time point/treatment and additional observation after discontinuation separately, and retain the scope for which direct results on maintenance are unavailable.
Why this condition is needed: Required to avoid turning end-of-treatment results into a sustained effect over 5 months or an annual slope.
Application exceptions: Do not establish a sustained effect solely from the existence of additional observation.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N06 · Have the actual participants' diabetes, microalbuminuria and CKD stage been verified?

Current findings: S01 is a pilot trial in adults aged 35–65 years with type 2 diabetes and persistent microalbuminuria, with 40 participants. CKD stage is unspecified, and this is not the same population as dialysis, transplant or nondiabetic CKD populations.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.
Reason for missing information: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.
Required materials and conditions: Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage
Materials to obtain first: Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage
Further research: Compare original eligibility criteria, baseline distributions and stage data, and review direct comparisons by stage/cause separately.
Remaining uncertainty: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.
Conditions for verification: Retain the verified age/disease/albuminuria together with the unverified stage, and indicate population differences.
Why this condition is needed: Required to avoid extending early diabetic nephropathy to CKD of all causes/stages or to dialysis/transplantation.
Application exceptions: Do not replace the currently unspecified CKD stage with an arbitrary stage 1/2/3.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N07 · Can correction of deficiency be distinguished from additional supplementation in nondeficient participants?

Current findings: The retained manuscript contains both low plasma thiamine and indicators of adequate dietary intake. It did not classify everyone as deficient or replete. For the analysis exclusion of 1 participant with very high baseline thiamine and possible prior supplementation, the arm and the extent of applicability to GFR remain unverified.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.
Reason for missing information: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.
Required materials and conditions: Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status
Materials to obtain first: Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status
Further research: Link nutritional-status definitions and analyses by status to actual renal-function denominators.
Remaining uncertainty: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.
Conditions for verification: Distinguish verified status indicators from unverified uniform deficiency and separately attributable effects.
Why this condition is needed: Required to avoid harmonizing low plasma levels and indicators of dietary adequacy into a single deficient/nondeficient population.
Application exceptions: Do not confuse the analysis exclusion of 1 participant with high thiamine levels with uniform deficiency status across the whole population.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N08 · Has the actual balance of placebo and usual treatment been verified?

Current findings: The comparator is placebo with usual diabetes/blood-pressure treatment. The current manuscript explicitly notes imbalances in background treatment, including insulin. Changes and rescue treatment by arm, and the adjusted contribution of thiamine, have not been established.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.
Reason for missing information: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.
Required materials and conditions: Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment
Materials to obtain first: Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment
Further research: Compare baseline/follow-up differences in concomitant treatment and their impact on analysis against the original materials.
Remaining uncertainty: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.
Conditions for verification: Distinguish placebo/usual care from actual imbalances and unverified changes/adjustments.
Why this condition is needed: Required to avoid attributing differences in background treatment to thiamine's contribution.
Application exceptions: Compare the actual effect of interest and analysis without requiring every change in both arms to be identical.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S03

N09 · At what level were randomization and concealment procedures reported?

Current findings: S01 reports a random-number table, central allocation and numbered opaque envelopes. The retained assessment also distinguishes this from an independent audit of concealment implementation. Do not describe the 40-person pilot trial as certified as a formal confirmatory trial.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.
Reason for missing information: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.
Required materials and conditions: Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records
Materials to obtain first: Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records
Further research: Compare allocation, concealment and baseline-characteristic data for the outcome of interest.
Remaining uncertainty: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.
Conditions for verification: Link the level of allocation/concealment recorded in the original source to unverified implementation and baseline limitations.
Why this condition is needed: Required to avoid claiming that allocation/concealment has been verified solely from the randomized-trial label.
Application exceptions: Distinguish reported procedures from an independent audit of implementation, and do not call the pilot trial a formal confirmatory trial.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N10 · Have reported blinding and actual adherence/blinding success been distinguished?

Current findings: Blinding of participants, care providers and assessors is reported, but the actual adherence rate and blinding success remain unverified. Do not erase this limitation solely because the creatinine-derived measure is objective.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Reported blinding and actual success/adherence have different levels of verification.
Reason for missing information: Reported blinding and actual success/adherence have different levels of verification.
Required materials and conditions: Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm
Materials to obtain first: Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm
Further research: Link data on actual blinding, adherence and changes by arm to the original analysis.
Remaining uncertainty: Reported blinding and actual success/adherence have different levels of verification.
Conditions for verification: Record whose blinding was reported separately from gaps concerning success/adherence.
Why this condition is needed: Required to avoid turning the double-blind label into actual balance of exposure or absence of bias.
Application exceptions: Do not remove post-allocation deviations or changes in measurement/treatment on the grounds that the formula-derived value is objective.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N11 · Have the formula, units and measurement boundaries of the value labeled GFR been verified?

Current findings: The original article calls it GFR, but the selected value is the end mean derived using Cockcroft–Gault at 3 months, in mL/min. The table notes recorded at the time mention Cockcroft–Gault/Jaffé; the value was not recast as body-surface-area-adjusted eGFR or measured GFR. The current work checked the retained location and did not newly audit the original measurement procedures.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.
Reason for missing information: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.
Required materials and conditions: Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures
Materials to obtain first: Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures
Further research: Check the table notes and original measurement/calculation procedures to extract results by the same measure and units.
Remaining uncertainty: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.
Conditions for verification: Distinguish the formula, units and labeling from unverified measurement procedures/errors.
Why this condition is needed: Required to avoid turning a formula-derived value into measured GFR, body-surface-area-adjusted eGFR or an annual slope.
Application exceptions: What was read in the current work was the retained extraction and the location of the notes, not a new audit of measurement in the original PDF.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N12 · Have the page's target and the original trial's primary endpoint been distinguished?

Current findings: GFR is this page's target, and the original trial's primary endpoint is urinary albumin. The retained primary_result also explicitly states that the page's target differs from the trial's primary endpoint. Do not transfer a reduction in urinary albumin to inhibition of renal-function deterioration.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified.
Reason for missing information: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified.
Required materials and conditions: The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan
Materials to obtain first: The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan
Further research: Compare the registry and plan with the reported endpoint hierarchy, keeping urinary-albumin and renal-function results separate.
Remaining uncertainty: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified.
Conditions for verification: Keep the page's renal-function target separate from the trial's primary urinary-albumin endpoint, and indicate the gap in comparison with the original plan.
Why this condition is needed: Required to avoid automatically transferring a reduction in urinary albumin to improved renal function or inhibition of long-term progression.
Application exceptions: GFR being this page's target does not mean it was preregistered as the trial's primary endpoint.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N13 · Have the baseline and 3-month end means±SD been retained unchanged?

Current findings: The baseline means±SD in the retained original S01 table are thiamine 85±19 and placebo 93±23 mL/min. The 3-month end means±SD are 90±30 and 97±18 mL/min. These are all arm-specific marginal means and SD, distinct from change SD and between-group CI. Analyzed/completer denominators remain null.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified.
Reason for missing information: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified.
Required materials and conditions: S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators
Materials to obtain first: S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators
Further research: Extract the original table together with the analyzed denominator at each time point and the definition of dispersion.
Remaining uncertainty: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified.
Conditions for verification: Assign the original retained arm-specific means/SD to the correct time points/units, leaving gaps in analyzed denominators.
Why this condition is needed: Required to avoid turning arm-specific baseline/end values and SD into change SD or causal-effect intervals.
Application exceptions: Do not fill in analyzed denominators from the 20/20 allocation or newly calculate the difference between the two time points.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N14 · Have the historical end-mean difference and the adjusted effect been distinguished?

Current findings: The existing unadjusted end-mean difference is −7 mL/min. With baseline means of 85 versus 93, this value is not interpreted as a causal effect or harm. The originally reported between-group estimate, baseline-adjusted effect and CI are null, and no calculation was created in the current work.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.
Reason for missing information: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.
Required materials and conditions: Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval
Materials to obtain first: Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval
Further research: Compare effect magnitude only when the original adjusted model, between-group estimate and analyzed denominators have been obtained.
Remaining uncertainty: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.
Conditions for verification: Record the historical unadjusted end-mean difference separately from the unverified adjusted causal effect/interval.
Why this condition is needed: Required to avoid interpreting a simple difference in end means with baseline differences as thiamine's causal effect or harm.
Application exceptions: −7 is existing descriptive arithmetic in the manuscript, not a value calculated, estimated or prescribed in the current work.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N15 · Have the 20/20 allocation and actual GFR analyzed/completer denominators been distinguished?

Current findings: Randomization involved 40 participants, 20/20. Analysis exclusion of 1 participant with very high baseline/urinary thiamine and possible prior supplementation is reported, but the arm and scope of applicability to GFR analysis remain unverified. GFR analyzed/completer denominators were not filled in as 20/20 or 19/20.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.
Reason for missing information: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.
Required materials and conditions: Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion
Materials to obtain first: Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion
Further research: Compare the original flow diagram and analysis exclusions with the arm-specific denominators in the GFR table.
Remaining uncertainty: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.
Conditions for verification: Distinguish allocation from analysis/completion, and preserve unverified denominators as null.
Why this condition is needed: Required to avoid automatically using the 40 randomized participants as 40 analyzed participants or as 20/20 outcome denominators.
Application exceptions: From the existing record of 1 participant excluded from analysis, do not infer that an arm had 19 participants.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N16 · Have GFR missing data, analysis populations and change variance been verified?

Current findings: Beyond the exclusion of 1 participant, arm-specific GFR missing-data handling and analysis populations remain unverified. Paired-change SD and baseline–follow-up correlation are also null. Do not use arm-specific marginal SD as change SD or establish ITT without the original source.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.
Reason for missing information: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.
Required materials and conditions: ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation
Materials to obtain first: ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation
Further research: Link the original analysis population, missing-data/sensitivity handling and change variance to the outcome of interest.
Remaining uncertainty: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.
Conditions for verification: Retain the reported exclusion and unverified analysis/missing data and paired variance, without creating new estimates.
Why this condition is needed: Required to avoid reconstructing missing-data handling or change CI from known marginal SD and randomized numbers.
Application exceptions: Do not label the analysis population ITT without the original source.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N17 · Have the exact P, CI and clinical importance been verified?

Current findings: The exact GFR P, CI, adjusted effect and MCID are null. Intervals were not reconstructed merely because arm-specific SD are available. These data do not support saying that clinically important benefit has been excluded or harm established.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.
Reason for missing information: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.
Required materials and conditions: Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model
Materials to obtain first: Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model
Further research: Obtain the original estimate, CI, exact P and endpoint-specific basis for importance to review the scope of interpretation.
Remaining uncertainty: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.
Conditions for verification: Link the original intervals/importance criteria, or indicate why interpretation is not possible.
Why this condition is needed: Required to avoid concluding an effect of 0, exclusion of clinical benefit or equivalence from the word nonsignificant alone.
Application exceptions: Do not propose arbitrary numbers for sample size, duration or the minimum important difference.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N18 · Has a nonsignificant result been kept from being recast as an effect of 0 or equivalence?

Current findings: The authors reported no statistically significant effect on GFR during treatment. The manuscript did not strengthen this to a true effect of 0, equivalence, exclusion of clinical benefit or exclusion of inhibition of long-term progression. It also retained the gap in exact effect magnitude.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.
Reason for missing information: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.
Required materials and conditions: Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit
Materials to obtain first: Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit
Further research: Review the original nonsignificant results together with intervals/denominators, avoiding an inaccurate interpretation as an effect of 0.
Remaining uncertainty: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.
Conditions for verification: Preserve the reported direction together with uncertainty, distinguishing them from a true effect of 0, equivalence or exclusion of benefit.
Why this condition is needed: Required to avoid strengthening verified nonsignificant results into definitive favorable or unfavorable conclusions.
Application exceptions: Retain the record of nonsignificance, but do not use it to assign a new efficacy/safety grade.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N19 · Have reports, mirrors and companion reports been kept from being summed as independent trials?

Current findings: For the locked 3-month CG result, the sole direct family at the time was TF01. Publisher PDF/HTML, PubMed and author uploads are mirrors, while S03/04 are correspondence. Participant-level overlap in the S05–08 companion reports is unresolved, so no additional replications or participants were counted.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.
Reason for missing information: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.
Required materials and conditions: TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results
Materials to obtain first: TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results
Further research: Compare family/registry/report/result/participant relationships to separate independent comparisons from potential overlaps.
Remaining uncertainty: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.
Conditions for verification: Distinguish verified families from provisional links, and preserve only their contributions to the direct locked result.
Why this condition is needed: Required to avoid counting publisher/PubMed/author mirrors and companion analyses as independent replications/participants.
Application exceptions: Do not turn unverified participant overlap in companion reports into confirmation of either the same cohort or a different trial.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S03 S04 S05 S06 S07 S08

N20 · Have the substantive content of the critical letter and the unread reply been distinguished?

Current findings: S03 is a critical letter on background treatment and urinary-albumin summaries/interpretation, not a correction, retraction or new trial. The body of the S04 reply was unread at the time. Do not assume that a difference of medians equals the median of individual changes or state that the authors' substantive response was verified.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The role of the critique has been verified, but the actual arguments in the reply remain unverified.
Reason for missing information: The role of the critique has been verified, but the actual arguments in the reply remain unverified.
Required materials and conditions: S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions
Materials to obtain first: S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions
Further research: Compare the full reply with the points in the original critique by endpoint, checking actual correction events separately.
Remaining uncertainty: The role of the critique has been verified, but the actual arguments in the reply remain unverified.
Conditions for verification: Keep the scope of the verified critique separate from that of the unread reply.
Why this condition is needed: Required to avoid claiming that the authors' substantive reply was read or turning correspondence into a new trial/correction.
Application exceptions: Do not automatically transfer the issue concerning urinary-albumin medians to an error in the GFR result.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S03 S04

N21 · Have the same participants and additional results in S05–S08 been verified?

Current findings: S05 risk-factor, S06 transketolase, S07 protein-marker and S08 enzyme reports are companion discovery materials. Some registry leads exist, but recruitment wording differs, so they are neither established as the same 40 participants nor counted as independent additional participants. Do not read the S08 repository upload date as the year of a new trial.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Full texts, participant-level links and additional contributions to the direct CG result remain unverified.
Reason for missing information: Full texts, participant-level links and additional contributions to the direct CG result remain unverified.
Required materials and conditions: Registration, recruitment, populations and denominators; participant/result links between reports
Materials to obtain first: Registration, recruitment, populations and denominators; participant/result links between reports
Further research: Compare full companion reports, recruitment/registration and denominators to verify cohort links.
Remaining uncertainty: Full texts, participant-level links and additional contributions to the direct CG result remain unverified.
Conditions for verification: Separate verified links from unverified participant-level overlap.
Why this condition is needed: Required to avoid adding companion analyses as new participants or direct replications.
Application exceptions: Do not establish that all of the same 40 participants were included solely from a shared registry lead.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S05 S06 S07 S08

N22 · Have a printed registration number and actual reading of the registry/plan been distinguished?

Current findings: S01 prints CTRI2008/091/000112. The official S15 lookup at the time did not obtain the actual registry record because of a human-verification barrier. Registration dates and comparisons of plans/analyses/hierarchy remain unverified; no conclusion of nonregistration is drawn.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Beyond the number, the actual original registry and plan contents remain unread/unverified.
Reason for missing information: Beyond the number, the actual original registry and plan contents remain unread/unverified.
Required materials and conditions: CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy
Materials to obtain first: CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy
Further research: In an authorized update, link the actual registry/plan and change history to the outcome hierarchy.
Remaining uncertainty: Beyond the number, the actual original registry and plan contents remain unread/unverified.
Conditions for verification: Record the reported number, actual failure/nonreading and gaps in the prespecified hierarchy.
Why this condition is needed: Required to avoid turning a printed number into comparison with the entire registry record or verification of the prespecified hierarchy.
Application exceptions: Do not use an access barrier as evidence of nonregistration.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S15

N23 · Have the levels of verification of public funding and conflict-of-interest declarations been distinguished?

Current findings: S01 records public/nonprofit support from Pakistan's HEC, a Warwick doctoral programme and the British Heart Foundation, along with a declaration of no conflicts of interest. Product provision/involvement and an independent audit remain unverified. Do not turn declarations into independent replication or certification of absence of bias.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Reported funding/declarations are available, but product involvement and independent verification remain unverified.
Reason for missing information: Reported funding/declarations are available, but product involvement and independent verification remain unverified.
Required materials and conditions: Reported funding; product provision/involvement; author relationships; scope of independent verification
Materials to obtain first: Reported funding; product provision/involvement; author relationships; scope of independent verification
Further research: Compare original funding, product provision and relationships, and review independent replication separately.
Remaining uncertainty: Reported funding/declarations are available, but product involvement and independent verification remain unverified.
Conditions for verification: Retain reported declarations together with gaps in product involvement/independent verification.
Why this condition is needed: Required to avoid turning reported declarations into an independent audit of implementation or replication.
Application exceptions: Do not automatically exclude results or establish absence of bias solely from funding.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N24 · What do the different stage, duration and eGFR change in S02 answer?

Current findings: S02 is a study in type 2 diabetes and CKD3 lasting 24 weeks, with 35 participants allocated 18/17. Preserve median eGFR changes of 1.59 versus 1.78 mL/min/1.73m² and the existing difference of −0.19 and P=0.61. Actual route, adult age, salt/product and analyzed denominators/CI remain unverified within the abstract's scope. An annual slope or equivalence was not verified.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.
Reason for missing information: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.
Required materials and conditions: S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI
Materials to obtain first: S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI
Further research: Verify actual exposure, change, denominators/intervals in the adjacent full text and review them as a separate question.
Remaining uncertainty: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.
Conditions for verification: Indicate the scope of the adjacent abstract and the unverified exposure/denominators and precision.
Why this condition is needed: Required to avoid transferring results with a different measure and duration into direct replication of the 3-month CG result.
Application exceptions: Do not fill in analyzed denominators from the randomization of 35 participants, 18/17.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S02

N25 · Have S02 and S22 been kept from being counted as different trials?

Current findings: Preserve the S02 online date of 2025-06-12 and print publication record of 2026. The S22 KKU bibliographic entry refers to the same TF02 and is not an additional trial. TF02 concerns change in body-surface-area-adjusted eGFR over 24 weeks, distinct from direct replication of the CG end mean at 3 months.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: This verifies bibliographic/family and measure boundaries, not the adjacent effect.
Reason for missing information: This verifies bibliographic/family and measure boundaries, not the adjacent effect.
Required materials and conditions: Online/print dates, DOI/institutional bibliography and links to the same TF02 report
Materials to obtain first: Online/print dates, DOI/institutional bibliography and links to the same TF02 report
Further research: Retain links to the same DOI/report, and verify any new independent comparison separately.
Remaining uncertainty: This verifies bibliographic/family and measure boundaries, not the adjacent effect.
Conditions for verification: Distinguish the bibliography of the same TF02 report and its different measure/duration relative to the locked question.
Why this condition is needed: Required to avoid adding an institutional bibliographic entry as an independent replication.
Application exceptions: Do not arbitrarily harmonize the 2025 online and 2026 print publication years into a single year.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S02 S22

N26 · Has the relationship between the review's 0.31 estimate and the original end means been verified?

Current findings: In the S12 review, GFR MD0.31 and CI[−4.51,5.13] do not directly correspond to the descriptive difference between the original end means of 90 versus 97. The possibility of a different estimand, change or additional data remains unresolved. They were not automatically judged to represent the same effect or a review error/conflicting information.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The actual analysis/data provenance of the review estimate remains unverified.
Reason for missing information: The actual analysis/data provenance of the review estimate remains unverified.
Required materials and conditions: S12 estimand, denominators, additional-data/change definitions and links to original results
Materials to obtain first: S12 estimand, denominators, additional-data/change definitions and links to original results
Further research: Compare the review's extraction table, estimand and additional data with the original results.
Remaining uncertainty: The actual analysis/data provenance of the review estimate remains unverified.
Conditions for verification: Retain the unverified link between the review's MD/CI and the original end means.
Why this condition is needed: Required to avoid removing the possibility of a different analysis and automatically declaring an error or the same effect.
Application exceptions: Do not declare a review error or conflicting information solely from the current difference.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S12

N27 · Has benfotiamine been transferred into a direct effect of ordinary thiamine?

Current findings: S09 Alkhalaf2010 concerns benfotiamine, TF03. Preserve the access limitations for the primary abstract/full text at the time. Do not import its effects, safety or denominators into the ordinary-thiamine CG result at 3 months.
Verification status: Does not apply
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Because it is a different molecule, it does not meet the conditions of the locked direct comparison.
Reason for missing information: Because it is a different molecule, it does not meet the conditions of the locked direct comparison.
Required materials and conditions: Distinctions between molecule/exposure, endpoints and trial families
Materials to obtain first: Distinctions between molecule/exposure, endpoints and trial families
Further research: Check the relevant original materials when separately reviewing a question about the derivative.
Remaining uncertainty: Because it is a different molecule, it does not meet the conditions of the locked direct comparison.
Conditions for verification: Exclude the different derivative TF03 from the locked direct comparison.
Why this condition is needed: Required to avoid attributing results and safety for other derivatives to ordinary thiamine.
Application exceptions: Retain the historical access limitations for S09.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S09

N28 · Has the individual contribution been verified from combination products or multinutrient registry records?

Current findings: S10 concerns thiamine+folic-acid cognition data in maintenance hemodialysis. S18 NCT01473914 is a registry index record for multinutrient/trace-element supplementation. Neither is a direct CG comparison of single-ingredient ordinary thiamine in early diabetic nephropathy.
Verification status: Does not apply
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.
Reason for missing information: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.
Required materials and conditions: Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results
Materials to obtain first: Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results
Further research: For combination/dialysis questions, separately review the results and whether the individual contribution can be identified.
Remaining uncertainty: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.
Conditions for verification: Separate S10 combination cognition data and the S18 multinutrient registry record from the locked direct comparison.
Why this condition is needed: Required to avoid turning combination results into the renal-function contribution of single-ingredient ordinary thiamine.
Application exceptions: Do not label a registry index record as completed results.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S10 S18

N29 · Have status associations, acute AKI and animal data been transferred into chronic oral effects?

Current findings: S19 concerns observational thiamine-status data in ESRD, S20 associations in critically ill patients with AKI, and S21 animal CKD transporter data. Do not count them as causal renal-function effects of chronic oral ordinary thiamine in humans or as additional direct families/participants.
Verification status: Does not apply
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The designs and populations/exposures differ, so these do not apply to the locked direct comparison.
Reason for missing information: The designs and populations/exposures differ, so these do not apply to the locked direct comparison.
Required materials and conditions: Distinctions between population/design, exposure, endpoints and data roles
Materials to obtain first: Distinctions between population/design, exposure, endpoints and data roles
Further research: For each separate question, verify eligible direct materials and the scope actually read.
Remaining uncertainty: The designs and populations/exposures differ, so these do not apply to the locked direct comparison.
Conditions for verification: Retain the design and population differences in S19–S21.
Why this condition is needed: Required to avoid calling observational/acute/animal data a causal effect of chronic oral treatment in humans.
Application exceptions: Do not expand the scope of index/abstract reading into full-text review.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S19 S20 S21

N30 · Do single-dose 100 mg data in ESRD answer chronic 300 mg safety?

Current findings: S11 is an abstract on pharmacokinetics in ESRD following a single oral dose of ordinary thiamine nitrate or benfotiamine, 100 mg, over 24 hours. It does not establish renal benefit, safety regarding accumulation, stage-specific doses or dialysis prescribing for chronic 300 mg ordinary thiamine.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.
Reason for missing information: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.
Required materials and conditions: S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms
Materials to obtain first: S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms
Further research: Separately verify pharmacokinetic/harm data for the same molecule, stage and repeated exposure.
Remaining uncertainty: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.
Conditions for verification: Separate the reported single-dose conditions from gaps concerning chronic harms/dose.
Why this condition is needed: Required to avoid turning pharmacokinetic exposure into chronic efficacy or prescribing by kidney-disease stage.
Application exceptions: Do not harmonize single-dose nitrate/benfotiamine with the trial's 300 mg regimen whose salt was not reported.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S11

N31 · Has the identity of the S13 SmPC product and the trial product been established as the same?

Current findings: S13 is the Flamingo UK thiamine hydrochloride 100 mg SmPC, PL43461/0038. Preserve the historical update record of 2025-09-08 and text revision of 2025-02-18. Do not use this product to identify the salt, manufacturer, excipients or stage-specific dose in S01.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified.
Reason for missing information: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified.
Required materials and conditions: Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product
Materials to obtain first: Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product
Further research: Verify the relationship between the actual trial product and the authorized product, and the version/warnings.
Remaining uncertainty: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified.
Conditions for verification: Separate historical verification of the separate product from the unverified trial product.
Why this condition is needed: Required to avoid substituting a separate regulated product for the unreported trial product.
Application exceptions: Do not turn an authorized product's doses/warnings into an individual CKD prescription.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S13

N32 · Does the absence of an established UL mean unlimited safety?

Current findings: Do not interpret the absence of an upper intake level in S14 NIH ODS as unlimited safety. Preserve the locations of the medication explanations for Furosemide and fluorouracil, but do not create incidence rates or high-dose CKD prescriptions. No UL does not mean unlimited safety.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.
Reason for missing information: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.
Required materials and conditions: Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population
Materials to obtain first: Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population
Further research: Compare official explanations separately with harms for the actual exposure/population concerned.
Remaining uncertainty: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.
Conditions for verification: Retain insufficient data and medication wording together with gaps in quantitative harms.
Why this condition is needed: Required to avoid turning the absence of an established UL into high-dose CKD safety or unrestricted intake.
Application exceptions: Do not use general explanations as direct CKD trials or prescribing guidance.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S14

N33 · Have denominators for adverse reactions, serious events and discontinuations been verified?

Current findings: AE/SAE, discontinuations due to adverse reactions and exact exposure denominators/duration in the selected oral trial remain unverified. Do not describe insufficient reporting as 0 events or as certification of individual safety. Do not transfer parenteral reactions into oral incidence rates.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Arm-specific harm events, exposure and collection/discontinuation data remain unverified.
Reason for missing information: Arm-specific harm events, exposure and collection/discontinuation data remain unverified.
Required materials and conditions: Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation
Materials to obtain first: Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation
Further research: Verify arm-specific harm collection, denominators/duration and discontinuations for the same oral regimen.
Remaining uncertainty: Arm-specific harm events, exposure and collection/discontinuation data remain unverified.
Conditions for verification: Retain unverified events/denominators and duration for the original harms data.
Why this condition is needed: Required to avoid turning unverified quantitative harms into 0 events/0 risk.
Application exceptions: Do not transfer reactions to injectable products into oral incidence rates.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S11 S13 S14

N34 · Have long-term accumulation and doses for special populations/by stage been verified?

Current findings: Direct data on long-term high-dose CKD safety, accumulation, doses by kidney-disease stage and special populations/concomitant use remain unverified. Do not combine the mean at 3 months, single-dose ESRD pharmacokinetics and a separate authorized product into long-term/optimal-dose prescribing.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.
Reason for missing information: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.
Required materials and conditions: Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use
Materials to obtain first: Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use
Further research: For extension questions, review harms and direct dose comparisons for the same molecule, stage and repeated exposure.
Remaining uncertainty: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.
Conditions for verification: Indicate the scope for which direct long-term/special-population data are unavailable.
Why this condition is needed: Required to avoid extending a short-term pilot trial into long-term/stage-specific prescribing.
Application exceptions: Do not require all extension studies as prerequisites for the narrow question about the mean at 3 months.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S11 S13 S14

N35 · Does the 3-month CG readout answer questions about annual slope or kidney-failure events?

Current findings: The annualized_slope for the original 3-month CG end mean is null. Do not extend a reduction in urinary albumin or this readout into preventing dialysis, kidney failure or death, or slowing long-term progression. These events differ from the currently selected endpoint.
Verification status: Does not apply
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.
Reason for missing information: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.
Required materials and conditions: Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure
Materials to obtain first: Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure
Further research: For a long-term-progression question, review direct endpoints and adequate follow-up/denominators separately.
Remaining uncertainty: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.
Conditions for verification: Do not claim annual slope and long-term events as direct locked results.
Why this condition is needed: Required to avoid turning a surrogate renal-function readout and urinary albumin into patient-centered inhibition of progression.
Application exceptions: Distinguish the status of the current narrow numerical question from that of the long-term-event question.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S02

N36 · Has the actual body of NCT06322212 been read?

Current findings: For S17 NCT06322212, the structured body was not obtained at the time because access yielded a JavaScript shell/API failure. Do not read CKD background descriptions as actual eligible populations/results or add eligible families/participants.
Verification status: Unverified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: The actual registry body, eligibility/exposure and results remain unverified.
Reason for missing information: The actual registry body, eligibility/exposure and results remain unverified.
Required materials and conditions: Actual structured registry body; eligibility/exposure; results/status; original change history
Materials to obtain first: Actual structured registry body; eligibility/exposure; results/status; original change history
Further research: In an authorized update, verify the actual registry body and results/changes to reconsider the boundaries.
Remaining uncertainty: The actual registry body, eligibility/exposure and results remain unverified.
Conditions for verification: Distinguish the unacquired body and failed access from background/eligibility criteria.
Why this condition is needed: Required to avoid calling a JavaScript shell and CKD background descriptions actual participants/results.
Application exceptions: Do not automatically promote a registry lead to an eligible direct comparison or completed results.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S17

N37 · Have search attempts been distinguished from completed native-database/correction reviews?

Current findings: The original cutoff date is 2026-09-16, and the 41 general-web searches at that time were not an exhaustive native PubMed search. The S23 native query returned no result set because of an internal error, and S16 viewed only the Thai registry homepage. No external search, correction/retraction lookup or reading of the old qa/corrections.json was performed in the current work.
Verification status: Partly verified
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.
Reason for missing information: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.
Required materials and conditions: Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions
Materials to obtain first: Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions
Further research: In a separately authorized update, record actual search/registry/correction results and the scope of failures.
Remaining uncertainty: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.
Conditions for verification: Distinguish the historical 41 general-web searches from incomplete native lookups and the current local conversion.
Why this condition is needed: Required to avoid turning search errors, homepages and existing routes into exhaustive searches or current correction reviews.
Application exceptions: No new search in the current work does not mean 0 studies or no recent corrections.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S15 S16 S23

N38 · Are the existing D30 and document A being read as new clinical verification?

Current findings: Preserve the existing D, 30 and Caution and the original verdict, including axes such as E0/CX. Document A and self-checking by the same model are not independent clinical review or efficacy/safety certification. The current work converted stored materials into a table; no new grade, score or clinical calculation was created.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: This verifies the distinction between original values and document roles, not a new clinical verdict.
Reason for missing information: This verifies the distinction between original values and document roles, not a new clinical verdict.
Required materials and conditions: Original grade/score; document assessment; verification actor; actual scope of conversion
Materials to obtain first: Original grade/score; document assessment; verification actor; actual scope of conversion
Further research: If a new evidence event is authorized, link a separate version/decision to the clinical evidence.
Remaining uncertainty: This verifies the distinction between original values and document roles, not a new clinical verdict.
Conditions for verification: Preserve the original D30/Caution and document/self-checking records as historical values.
Why this condition is needed: Required to separate document self-checking from clinical/safety certification.
Application exceptions: Do not use the current table's statuses/counts as a new efficacy score.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01

N39 · Are summary links and past publication metadata being read as verification of current original sources/publication?

Current findings: Preserve the current 3121 identity, original URL, cutoff/publication and deployment metadata of 2026-09-16, and revision history. What was read in the current work was the local stored summary; historical access differs among the 23 provenance entries. All local_original_copy values are null. Summary links connect to retained locations/values/SHA, without claiming current external full-text reading or public publication in the current work.
Verification status: Met
Materials actually read: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work.
Why unverified: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.
Reason for missing information: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.
Required materials and conditions: ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links
Materials to obtain first: ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links
Further research: When new materials arrive, preserve everything before changes and reconsider the relevant rows, materials, criteria version and change decision.
Remaining uncertainty: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.
Conditions for verification: Link to the exact stored summary, and indicate current nonreading of external materials and local nonpublication.
Why this condition is needed: Required to distinguish reading retained stored summaries from external clinical originals/public publication in the current work.
Application exceptions: Do not use a local stored-summary SHA as the hash of an external PDF's original bytes.
Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods.

Related sources S01 S02 S03 S04 S11 S12 S13 S14