| 1 |
Met |
Full text not readStored summary read |
N01 · Claim and independent scopeWhich population, intervention, distance and time comparison does this table address?Required |
The original claim concerns 161.3 km race finishing time in experienced adult ultramarathon runners. The table presents a one-race comparison of oral single-ingredient B2 versus a color-matched placebo. subclaims=[]; pain, 400 m recovery, CK, vitamin status and laboratory time trials are separate outcomes. |
The identity and inclusion/exclusion boundaries of the independent claim have been linked to the current ID and exact original wording. This condition being met does not establish a reduction in finishing time. |
Linkage of the current claim, population, formulation/route, comparator and endpoint to the excluded endpoints on the same page |
In subsequent research, prespecify the finishing-time question for the same distance separately from the recovery question. |
| 2 |
Partly verified |
Full text not readStored summary read |
N02 · Ingredient and product identityAre the study's single-ingredient riboflavin and exact product specifications verified?Required |
The study reports oral capsules containing riboflavin as the single active nutrient. Documentation of the exact salt, product batch and complete excipients has not been verified. Results for B-vitamin combinations or other formulations are not treated as the same intervention. |
The molecule, single active nutrient and route are preserved, but the full product specifications have not been verified. |
Documentation of the trial capsule's molecule/salt, batch, active amount, complete excipients and quality |
Disclose batch specifications and analytical data for the trial product and directly compare interventions with the same specifications. |
| 3 |
Partly verified |
Full text not readStored summary read |
N03 · Actual population and selectionTo what extent do the actual runners match the population in the original claim?Required |
The actual data concern experienced adult ultramarathon participants in the 2016 Western States Endurance Run. Finishing time is restricted to 32 study completers with complete data. Exact age eligibility limits and renal/hepatic-disease and pregnancy subgroups are unverified. |
The race setting, experienced adults and actual time-analysis population have been linked, but detailed selection criteria and special-population coverage have not been verified. |
2016 WSER inclusion/exclusion criteria, age range, experience, baseline racing ability and special-population data |
Subsequent trials should specify racing experience and selection criteria and predefine population-specific applicability limits. |
| 4 |
Unverified |
Full text not readStored summary read |
N04 · Baseline B2 and dietIs it verified whether this is correction of deficiency or additional supplementation on top of adequate intake?Required |
Although presented as a supplementation question, the population has not been verified as deficient or adequate through measurements of baseline B2 markers, deficiency thresholds and total dietary intake. Unverified status is not used as confirmation of nondeficiency. |
The necessary baseline measurement/intake records could not be verified within the currently retained scope. |
Baseline B2 markers/deficiency thresholds, total dietary B2, concurrent supplements and baseline data by group |
Measure baseline B2, diet and concurrent supplementation, and plan prespecified effect-modification analyses by deficiency status. |
| 5 |
Met |
Full text not readStored summary read |
N05 · Planned dose and timingAre the two administrations in one race distinguished from long-term daily dosing?Required |
The plan is to administer oral B2 100 mg 0.5–1 hour before the start and 100 mg at 90 km. The planned total in one 161.3 km race is 200 mg. This is not a trial of long-term daily use of 200 mg or 400 mg. |
The planned route, amount and timing in the actual manuscript have been linked to correction QA02. This is distinct from the N06 question of whether everyone actually absorbed the planned amount. |
Administration specifications, oral route, timing before the start/at 90 km, and planned total amount |
Fix the timing within the same race, and design studies directly comparing administration timing/doses as separate questions. |
| 6 |
Partly verified |
Full text not readStored summary read |
N06 · Actual intake and deviationsDid everyone actually receive the planned second dose?Required |
Omission of the second dose and vomiting were reported, and analgesic use also occurred. The current records cannot verify that every runner fully received or absorbed the two planned capsules. |
The occurrence of deviations is preserved, but individual actual administered amounts and the scope of their analytical handling could not be verified. |
Individual administration/omission, vomiting, time available for absorption, adherence and analytical-handling records |
Record administration/deviations for each individual and analyze prespecified effects of assignment separately from effects of adherence. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · Placebo and active amountAre powder mass and active amount distinguished for the color-matched placebo?Required |
The placebo contains 95 mg maltodextrin and 5 mg of 10% beta-carotene powder per capsule. The retained nominal calculation is 0.5 mg/capsule of active beta-carotene, not an active amount of 5 mg. Race diet and usual care are not standardized. |
The reported ingredients and historical nominal calculation were verified, but measured batch content and physiological equivalence/inertness comparisons were not. |
Placebo batch/ingredients, maltodextrin and beta-carotene powder specifications, and assessment of physiological effects |
Disclose the control capsule's ingredients/color and measured content, and assess nonspecific differences from the intervention. |
| 8 |
Conflicting information |
Full text not readStored summary read |
N08 · Race care and conflicting medication dataAre the diet, usual-care and analgesic differences actually internally consistent?Required |
Race diet and usual care were not standardized. For medication use during the race in the placebo group, the text records 6 participants, Table 1 records 36% of 14 participants, and the sum across medication types is 5 participants. QA04 leaves these unreconciled and preserves reconciled count=null. |
The original text, table and total referring to the same medication-user count could not be verified as consistent. This is an internal conflict in the source data, not a difference between analytical estimates. |
Diet/race care in both groups, medication types/participant counts, original table/text and corrections, and analytical handling |
Cross-check individual concomitant-use data against the original table, and preplan recording/handling of common care and rescue treatment. |
| 9 |
Met |
Full text not readStored summary read |
N09 · Allocation designHas the randomized title been distinguished from actual alternating allocation?Required |
Actual allocation alternated by order of arrival at registration; it was not a random sequence. This differs from the randomized wording in the S04 conference title; QA03 records randomized=false according to the detailed Methods of the original journal article. |
The actual design identity was attributed to the retained detailed methods/corrections. Meeting the allocation-identity condition does not mean confounding was controlled or that this was a confirmatory RCT. |
Allocation by registration-arrival order, sequence generation, baseline balance and related report identities |
Subsequent comparisons should disclose the random sequence and its actual implementation, and assess balance in baseline racing ability. |
| 10 |
Unverified |
Full text not readStored summary read |
N10 · Allocation concealmentWas it impossible to predict or change the allocation sequence?Required |
Alternating allocation by registration-arrival order is predictable. Whether allocation concealment was effectively implemented has not been verified in the current records. |
The allocation procedure is known, but the information needed to assess concealment implementation/effectiveness is unverified. |
Allocation personnel/concealment implementation, registration process, any breaches and baseline characteristics |
Separate responsibility for sequence generation, storage and implementation from registration procedures, including an audit of the allocation process. |
| 11 |
Partly verified |
Full text not readStored summary read |
N11 · Maintenance of blindingAre participant/onsite-researcher blinding and noticing urine color distinguished?Required |
Blinding of participants and onsite researchers was reported. Urine color was noticed by 3 participants in the B2 group and 1 in the placebo group, so fully maintained blinding cannot be verified. The actual time-recording assessors and checks of maintained blinding are also unverified. |
The blinding report and cases of awareness were verified, but sufficient information on actual maintenance and the assessment stage is lacking. |
Blinding implementation, timing of noticing urine color, allocation guesses, assessors and checks of maintained blinding |
Collect allocation guesses and the timing of awareness, and specify blinding of those recording race times. |
| 12 |
Met |
Full text not readStored summary read |
N12 · Starting, finishing and analysis denominatorsWhat denominators do 44 participants, 37 participants and 32 participants each represent?Required |
Allocation/starting counts were 22 participants in the B2 group and 22 participants in the placebo group; finishing counts were 20 participants and 17 participants; and complete-data counts in Table 1 were 18 participants and 14 participants. The actual denominator for the finishing-time means is 32 participants, not 44 participants or 37 participants. |
The group-specific stages and denominators for the Table 1 means are clearly linked. They have not been renamed randomized n. |
Group-specific allocation/starting, finishing and data-completeness flow, and the identity of the Table 1 analysis |
Disclose the full participant flow and the actual analysis denominator for each outcome using consistent identifiers. |
| 13 |
Partly verified |
Full text not readStored summary read |
N13 · Nonfinishing and missing dataHow were nonfinishing and incomplete data after finishing handled?Required |
The retained records distinguish 7 nonfinishers among 44 starters from 5 finishers with incomplete data. Historical arithmetic gives group-specific nonfinisher counts of 2 participants/5 participants and incomplete-data counts after finishing of 2 participants/3 participants. These subtraction records are not new calculations, and the comparison of 32 participants does not recover the effect in all 44 assigned participants. |
Loss stages and retained group-specific counts have been linked, but the reasons, handling and estimation of the effect of interest in all starters could not be verified. |
Individual reasons for nonfinishing/missing data, the analysis plan for the effect in all assigned participants, and raw data |
Define the prespecified effect of interest including nonfinishers and missing-data sensitivity analyses, and report the full data flow. |
| 14 |
Partly verified |
Full text not readStored summary read |
N14 · Time endpoint and recordingFor what distance, at what time point and with what device was time measured?Required |
The outcome is finishing time (in hours) at completion of one 161.3 km ultramarathon race. It is the value for study completers in Table 1, not a standardized laboratory time trial or a 400 m recovery run. Timing-device and recording/adjudication details are unverified. |
The endpoint, distance, unit and completion time point were verified, but actual recording/verification procedures are unverified within the retained scope. |
Official race-completion time, timing device/adjudication, course conditions, record verification and Table 1 location |
Disclose official timing records and course/adjudication procedures, and audit measurement errors/differences. |
| 15 |
Unverified |
Full text not readStored summary read |
N15 · Finishing-time analysis hierarchyWas finishing time a prespecified primary efficacy endpoint?Required |
The study focuses on pain and recovery, and finishing time appears in a characteristics table. A registration/planned hierarchy establishing finishing time as a prespecified primary efficacy endpoint could not be verified. |
The fact that an outcome was reported does not by itself establish a prespecified primary (1st) endpoint or confirmatory analysis. |
Registration/protocol/SAP, endpoint/time-point hierarchy, the table's purpose and reasons for changes |
Fix the primary/supporting role of finishing time, testing hierarchy and handling of multiple comparisons before the race. |
| 16 |
Met |
Full text not readStored summary read |
N16 · Means, SD and unitsAre the Table 1 means and dispersion measures attributed to the same population/units?Required |
In Table 1, the 18 B2 participants have 27.26 ± 2.36 hours and the 14 placebo participants have 27.08 ± 2.88 hours, expressed as mean±SD. This SD is not a between-group CI or SE. |
The original means, dispersion notation and group-specific denominators were accurately linked to the retained results/inputs. Meeting the numerical-attribution condition is separate from establishing causal efficacy. |
Group-specific complete-data n, mean time, SD notation, and original table/units |
Disclose the dispersion definition for each outcome together with precise numerical values/denominators. |
| 17 |
Met |
Full text not readStored summary read |
N17 · Nonsignificance and interpretation limitsHas nonsignificance for time been kept from being converted into an effect of 0 or equivalence?Required |
The retained original table/manuscript states that a significant between-group difference in finishing time was not identified. Alternating allocation and selected-finisher analysis prevent this from establishing an effect of 0, equivalence or exclusion of important time benefit. |
The nonsignificance statement and its interpretation limits were linked to the same time endpoint and preserved. This condition being met does not establish no effect. |
The original table's no-difference statement, coherent between-group estimates/intervals and a validated important-difference criterion |
Prespecify coherent between-group intervals and important-difference criteria to provide interpretation beyond significance. |
| 18 |
Unverified |
Full text not readStored summary read |
N18 · Original CI and exact PAre author-reported between-group CI, exact P and adjusted estimates available?Required |
Author-reported finishing-time CI, exact P and adjusted causal effect are null in the retained stored summary. Historical t-reconstruction values are recorded separately and do not fill these original values. |
The required originally reported estimates/tests and adjusted values could not be verified and cannot be replaced with existing descriptive calculations. |
CI for the original time outcome, exact test P, adjusted model/estimand and results table |
Disclose the original between-group CI/P and model/denominator for the prespecified effect of interest on finishing time. |
| 19 |
Met |
Full text not readStored summary read |
N19 · Historical mean difference and directionAre the sign and descriptive meaning of the retained mean difference preserved?Required |
The retained mean difference is B2−placebo +0.18 hours (+10.8 minutes); a positive value is descriptively in the slower direction. The original retained values are 0.18000000000000327 hours and 10.800000000000196 minutes. This is arithmetic on selected-sample means, not a new estimate of causal harm or significant delay. |
The inputs, direction and original values of the retained calculation were accurately distinguished from the rounded reader-facing expression. No new calculation was performed in this work. |
Historical arithmetic inputs, B2−placebo direction, original mean-difference values/limits and calculation provenance |
Subsequent research should report the prespecified direction and between-group estimates/intervals for the overall effect of interest. |
| 20 |
Met |
Full text not readStored summary read |
N20 · Historical pooled intervalCan the assumptions of the equal-variance t-reconstructed interval be verified?Supplementary |
The historical pooled-variance unpaired t model is a descriptive model for the selected sample. The retained 95% CI is [−1.7108254419152404, 2.0708254419152468] hours, P = 0.8471597784689339, SE = 0.925843873613083 hours, and df = 30. Equal variance is an explicit calculation assumption, not a verified author-used t subtype. It does not remedy missingness/confounding. |
The historical calculation's model, values and assumptions were linked separately from the unverified original CI. This meets a calculation-preservation condition, not a causal-precision condition. |
Original retained pooled-calculation values, inputs, assumptions, selected sample and distinction from original reporting |
Disclose participant-level data and a prespecified model to examine direct estimation that accounts for selection/nonrandomization limitations. |
| 21 |
Met |
Full text not readStored summary read |
N21 · Historical Welch sensitivity analysisWere the unequal-variance sensitivity results also preserved as a separate model?Supplementary |
The historical Welch unpaired t sensitivity analysis uses an unequal-variance model. The retained 95% CI is [−1.7761840334977923, 2.136184033497799] hours, P = 0.8512055048234594, SE = 0.9496732938644559 hours, and df = 24.925799135526574. These results use assumptions different from pooled analysis; they are neither a source-data conflict nor author CI. |
Both models were preserved and attributed to their respective assumptions; the conclusion was not changed through new recalculation/model selection. |
Retained Welch values, assumptions, inputs, differences from pooled results and verification status of the original interval |
Prespecify variance assumptions and sensitivity analyses for missingness/confounding, and report model-specific results transparently. |
| 22 |
Unverified |
Full text not readStored summary read |
N22 · Important difference and equivalenceIs there a basis for deciding how much faster a time constitutes important benefit?Required |
A validated important difference (MCID) for the same race/runners is null. The retained record has equivalence_demonstrated=false, and reconstructed intervals allow both faster and slower times. NNT is null because this continuous-time/selected descriptive comparison has no eligible binary-risk/time estimate. |
The relationship between an important difference and a coherent original interval could not be verified, so exclusion of important benefit or equivalence cannot be claimed. |
Justified important-difference and equivalence thresholds for the same race/population, and appropriate original estimation intervals |
Justify an important difference in the runner/race context and prespecify a precision/equivalence design incorporating it. |
| 23 |
Unverified |
Full text not readStored summary read |
N23 · Confounding and adjusted effect of interestIs a comparative effect accounting for baseline racing ability and selection verified?Required |
Adjustment for baseline racing ability on an equivalent course and adjusted causal estimation have not been verified. The mean difference from predictable alternating allocation and selected-completer analysis cannot be regarded as estimating the intervention effect in all starters. |
Baseline balance/adjustment and full-analysis data needed for the causal effect of interest could not be verified. |
Baseline racing ability, experience on the same course, nutritional/care covariates and prespecified adjustment/analysis of all participants |
Measure racing ability before allocation and prespecify the effect of interest and handling of covariates/losses. |
| 24 |
Unverified |
Full text not readStored summary read |
N24 · Acquisition of registration and plansHave the official registration, protocol and SAP been compared with the original report?Required |
S01 registration_id is null; registration was not reported in the original at the time, and the external record was recorded as unverified. Ethics approval or the existence of an article is not reading the full registration, protocol or SAP. Access to the relevant external materials was not attempted in this work; they were not acquired or read. |
Full texts needed to actually compare the prospective plan with the original results were not acquired/read in this work. This differs from absence of registration or confirmed selective reporting. |
Full original registration/protocol/SAP, versions/dates and endpoint/analysis comparisons |
Disclose original plans and change histories, and compare outcome-specific plan adherence/reasons for changes. |
| 25 |
Partly verified |
Full text not readStored summary read |
N25 · Conference report and same familyAre the conference title and original journal article being counted as independent replications?Required |
The HTML/PDF/index versions of the S01 original article are the same report. S04 is a probable conference companion on the same investigators/intervention topic, but full-text/exact-identity comparison is incomplete. It is not counted as a separate cohort or independent replication; randomized in the conference title differs from the alternating allocation in S01. |
The probable family link and exclusion of duplicate counting were verified, but the exact identity of the full conference text is unverified. |
S01/S04 original reports, full conference text, cohort/time-point/participant linkage and design wording |
Link participants, registrations and time points across related reports, and disclose a map of unique families and outcome locations. |
| 26 |
Met |
Full text not readStored summary read |
N26 · Recovery and other favorable outcomesAre positive signals for pain/400 m recovery being substituted as time evidence?Required |
Favorable signals for some pain and 400 m recovery results from the same study are preserved. These outcomes differ from finishing time for the 161.3 km race and do not replace the nonsignificant finishing-time result. CK and vitamin status are also separate endpoints. |
Favorable adjacent outcomes and the boundary of the selected time outcome were preserved together according to the manuscript. No new numerical values or intervals for positive signals were created. |
Endpoint-specific results, time points, tests/hierarchy and finishing-time separation records from the same study |
Prespecify race performance and post-race recovery separately, and report endpoint-specific estimates/intervals and multiple comparisons. |
| 27 |
Met |
Full text not readStored summary read |
N27 · Ex PLUS and combination productDoes time to exhaustion with a combination product in nonathletes answer the single-ingredient B2 race-time question?Supplementary |
S02 Ex PLUS is a combination of multiple vitamins, minerals, taurine and inositol. It involved 32 healthy nonathletes, a 28-day intervention and a 14-day washout, testing time to exhaustion at 85% VO2max. Do not combine it as field-race finishing-time evidence for single-ingredient B2. |
The actual differences in ingredients, population, duration and endpoint in the current materials have been linked, allowing the exclusion role to be explained. This status does not confirm Ex PLUS or B2 efficacy. |
S02 ingredient table, population, exposure/washout, actual performance test and registration/original results |
Design a direct comparison in the same ultramarathon population differing only in single-ingredient B2. |
| 28 |
Partly verified |
Full text not readStored summary read |
N28 · 1984 swimming study and unresolved statusHave the swimming article's eligibility and numerical values been verified?Supplementary |
S05 is a candidate identified through the title and bibliography of a 1984 study of B2 supplementation, nutritional status and performance in elite swimmers. Incomplete access to the original/DOI resolution at the time prevented verification of age, exact endpoint, dose, design and effect/CI. The external original remains unread in the current work. |
Bibliographic identity is preserved, but the eligibility and precise numerical values of the performance data are unverified. |
Full original 1984 article, age/ingredient/dose, design, performance test, denominators and effect/intervals |
In a subsequent review that acquires the original, verify the actual sport, test and population, and separate evidence according to directness. |
| 29 |
Met |
Full text not readStored summary read |
N29 · 1992 population correctionHave the Winters1992 population and the swimming study been separated?Supplementary |
The title of S06 Winters1992 concerns B2 requirements/exercise adaptation in older women. QA01 separated it from the 1984 elite-swimming candidate. Access at the time was limited to official-index search metadata; no direct performance numbers were imported. |
The retained population/question correction and the boundary preventing numerical transfer were linked. Verification of the original article's results was not claimed. |
S06 bibliography, original article/abstract, exercise-adaptation/nutrient-requirement endpoints and QA01 correction |
Subsequent original-source review should first verify each population, endpoint and ingredient, then extract by independent question. |
| 30 |
Met |
Full text not readStored summary read |
N30 · Direction of exercise→B2 statusIs post-exercise B2 status in adult men an effect of supplementation→time?Supplementary |
S07 addresses the direction of exercise affecting B2 status in adult men. Historical access was limited to the publisher landing page, and this status response is not a direct result showing that B2 supplementation reduces race time. |
The boundary explaining the direction and endpoint differences in the current title/facts has been linked. |
S07 original article, exposure/outcome direction, nutritional-status tests/time points and actual comparison |
Design the performance-improvement question separately as a comparison differing only in B2 exposure. |
| 31 |
Met |
Full text not readStored summary read |
N31 · Female status and original MethodsIs the exercise challenge in women by fitness level a comparison of oral B2 versus placebo?Supplementary |
The S09 female data compare exercise challenge, fitness groups and B2 status; they are not a randomized oral B2 versus placebo supplementation trial. Use of B2-containing supplements was excluded, and the original Methods registration number was recorded as NL7891. Historical access to portions of abstract/Methods copies is separate from verification of the full official registration. |
The retained original Methods' exposure direction, exclusions and registration number were linked to their differences from the direct performance question. This does not mean the entire original/registration was read in this work. |
S09 original abstract/Methods, exposure/exclusion criteria, results, and original location and registration of NL7891 |
A performance-comparison question for single-ingredient B2 requires a separate intervention/control trial in the same population. |
| 32 |
Partly verified |
Full text not readStored summary read |
N32 · Registration discovery and mistaken identityHas discovery of the female study's registration been distinguished from the adjacent TCTR entry?Supplementary |
NL-OMON24874 and NL-OMON48355 in S10 are discovery-level candidate aliases, and the detailed official registration was inaccessible at the time. QA05 identified TCTR20190907005 as an adjacent different entry, not the female study's registration. Unverified registration details were not used to fill in the S09 methods. |
The retained correction of mistaken identity has been linked, but exact comparison of official details/aliases is unverified. |
Official full text/identity of NL7891 and OMON candidates, comparison with the original Methods, and discovery-page structure |
Compare the identities of the official registration and original article using source materials, and mark uncertain aliases. |
| 33 |
Partly verified |
Full text not readStored summary read |
N33 · Replication and search scopeAre repeated citations in reviews and limited searching being read as independent replication or absence of studies?Required |
The retained direct-comparison family is UF2016 alone, and the recorded number of verified independent replications is 0. The S08 review's repeated citation of Hoffman is not a new trial. Historical searching comprised 63 general-web queries and 3 failed native database searches, without assurance of exhaustive searching. No new search was conducted in this work. |
Families/repeated citations and the actual historical search scope have been linked, but independent replication of the same question and exhaustive searching for unpublished work/corrections have not been verified. |
Unique-family/report map, actual search records, registration/unpublished/correction scope and full review article |
Subsequent reviews should transparently record the scope of searches, failures, registrations and corrections, and link independent comparisons addressing the same question. |
| 34 |
Partly verified |
Full text not readStored summary read |
N34 · Support and independenceWhat is the scope of foundation/public support and no-conflict declarations?Supplementary; required for independence claims |
S01 records support from the Western States Endurance Run Foundation, Rossi Family Foundation and VA resources/facilities, and the authors' declaration of no competing interests. Support roles, all donor provenance and product provision are unverified. Historical I2 is not certification of independent replication, external review or absence of influence. |
The level at which funding/declarations were verified is preserved, but information covering the full scope of independence is lacking. |
Funding/product provision, donor provenance, support roles, author declarations/employment and family map |
Disclose support roles, product provision, all interests and linkage to independent study families. |
| 35 |
Partly verified |
Full text not readStored summary read |
N35 · Vomiting and temporal signalWhat can be concluded about vomiting after the 90 km dose?Supplementary; required for harm interpretation |
The original record reports that two participants in the B2 group vomited within 1 hour after the 90 km dose. The temporal relationship of an event after dosing is preserved, but B2 causation and comparative risk/incidence are not established. |
The participant count and temporal signal were verified, but comparative ascertainment/denominators, recovery/re-exposure and alternative explanations were not sufficiently verified. |
Number of participants with vomiting, onset/recovery, administration/discontinuation/re-exposure, alternative causes, and placebo ascertainment/denominators |
Systematically collect exposure/event timing, discontinuation/recovery, alternative explanations and concomitant use, and plan comparable harm analyses. |
| 36 |
Partly verified |
Full text not readStored summary read |
N36 · Urine color and awareness eventsDo the 3 participants versus 1 participant noticing urine color represent harm incidence?Supplementary; required for harms/blinding |
The retained counts of participants who noticed urine color are 3 in the B2 group and 1 in the placebo group. This record signals a limitation in maintained blinding; it does not establish participant-level incidence of systematically collected adverse events or clinical harm. |
The awareness record was verified, but actual ascertainment denominators/definitions, timing and information for clinical-harm interpretation are unverified. |
Definition/timing of awareness, participant counts, ascertainment scope, actual denominators in both groups and blinding checks |
Collect awareness/allocation guesses identically in both groups and disclose ascertainment denominators and onset timing. |
| 37 |
Unverified |
Full text not readStored summary read |
N37 · Safety ascertainment and denominatorsWere adverse events, serious events and discontinuations due to harm systematically counted?Supplementary; required for safety claims |
Group-specific denominators and ascertainment scope for systematic adverse events, serious adverse events and discontinuations due to harm have not been verified. The existence of vomiting/color-awareness reports is distinct from complete ascertainment or absence of events. |
The required systematic definitions, ascertainment and exposure/loss/participant-level denominators could not be verified. Unverified information was not converted into 0 events. |
AE/SAE definitions in both groups, ascertainment procedures, participants/events, exposure time, discontinuations and loss denominators |
Track exposure and losses among all assigned participants, and record events, participants and discontinuations using the same procedures in both groups. |
| 38 |
Partly verified |
Full text not readStored summary read |
N38 · Official safety contextHave the meanings of no established UL and no known interactions been appropriately limited?Supplementary; required for general safety extensions |
The S03 NIH ODS context records that no UL was established because of limited harm data. This does not prove that high doses cannot cause adverse effects. No known clinically relevant drug interactions is likewise not extended to a guarantee of safety for all concomitant use. |
The retained general official context was verified, but it is not direct verification of all harms/concomitant use in the same race/at the same dose. The full official text was not read in this work. |
S03 official safety/interaction original text, update date, evidence scope and data on the same exposure/population |
Review harm data addressing the same dose/duration/concomitant use and official updates separately. |
| 39 |
Unverified |
Full text not readStored summary read |
N39 · Long-term use, special populations and interferenceDoes the evidence also answer dose/duration, special-population and test-interference questions beyond one race?Supplementary; required for scope extensions |
One-race data do not verify pregnancy, lactation, children, renal/hepatic disease, long-term high-dose use or test interference. They do not answer questions about the optimality of other doses/repeated races or persistence of effects after discontinuation. Study doses are not personal dosing recommendations or instructions to replace symptom assessment/treatment during a race. |
Direct evidence for this extended scope could not be verified in the current retained-material review. Extension conditions were not promoted merely because a narrow time result exists. |
Direct evidence on long-term/repeated dosing, vulnerable populations/renal or hepatic conditions, pregnancy/lactation/children, concomitant use and test interference |
For each needed extension, separately design a study with the appropriate population, duration and focus on harms/interactions or test interference. |
| 40 |
Met |
Full text not readStored summary read |
N40 · Current reading and preservation of original valuesHas this summary review been distinguished from historical full-text and verdict records?Required |
The materials actually read in this work are the Korean/structured evidence, bibliography, corrections and historical records in the currently retained 3124 stored summary. Original HTML/PDF access covering 8 pages and other partial access on 2026-09-16 are historical reports; access to external full texts was not attempted in this work, and they were not acquired or read. The original D·30/Caution and historical calculations/self-review are preserved; no new grade, verdict, search or calculation was produced. |
Original bytes/hashes, dates, current/historical reading and the scope of original-verdict preservation were recorded according to the actions actually taken. This table is not independent clinical/official certification or site publication. |
Current original/snapshot SHA, scope actually read, historical access/calculations, existing grade/score and reading receipts |
In a subsequent case where new evidence is permitted, preserve original values/previous originals together with dates, access and locations/versions before reviewing linkage conditions. |