| 1 |
Verified |
Full text not readStored summary read |
N01 · Independent questionDoes the table address only the between-group change in usual gait speed in frail older adults?Required |
The original claim is improvement of usual gait speed in frail older adults. The single question addresses community-dwelling adults aged 75 or older with a Fried score of 3 or higher, a planned oral NR regimen of 2,000 mg/day for 52 weeks versus placebo, and change in usual speed (m/s). |
The claim boundaries are specified in the identity of the retained assessment question. Verification of these boundaries does not verify a completed trial yielding that result or verify efficacy. |
Explicit boundaries of the original claim, population, planned oral NR, placebo, and change in usual speed at 52 weeks |
In a new study, specify usual speed as a single outcome of interest and prespecify the population, comparison, measurement time points, and analysis. |
| 2 |
Unverified |
Full text not readStored summary read |
N02 · Ingredient identityAre the NR salt, product, dosage form, and batch in the plan verified?Required |
The ingredient is retained as NR, but its salt, crystal form, brand, manufacturer, manufacturing source, dosage form, purity, batch, and release form are unverified. NIAGEN information from another trial was not copied into this plan. |
The retained identity fields are null or unverified. The molecular name NR alone cannot verify an identical salt, product, or basis for exposure conversion. |
Documentation of the exact NR salt, product, manufacturer, assayed purity, batch, and release form in NADage |
A suitable comparative study records the test product's analytical results, batch, and active ingredient together with the placebo composition to define a reproducible exposure. |
| 3 |
Partly verified |
Full text not readStored summary read |
N03 · Single interventionAre other active ingredients or exercise packages separated from the NR-versus-placebo comparison?Required |
The question requires an NR-versus-placebo contrast. The principle of not transferring effects from NMN, nicotinamide, niacin, resveratrol, or an exercise package is specified, but full product composition and common care have not been verified. |
The contrast to be selected is defined, but the actual plan's full composition and concomitant-intervention rules remain unverified. Requesting a single-component contrast differs from having implemented single-component exposure. |
Full product composition and rules for exercise, rehabilitation, diet, and active-ingredient use in both groups |
Specify standard care in both groups and record differences in exercise or rehabilitation, or design these as a separate factor, to estimate the NR contrast. |
| 4 |
Partly verified |
Full text not readStored summary read |
N04 · Frail populationAre the criteria of age 75 or older and Fried score 3 or higher, and the population actually selected, verified?Required |
The official registration index records criteria of community dwelling, age 75 or older, and a Fried Frailty Phenotype score of 3 or higher. The relationship between the investigator page's description of mild-to-moderate frailty, detailed exclusion criteria, and the population actually selected is unverified. |
The criteria are a description of the plan verified from a limited official index. The full registration and actual baseline table cannot be verified from the retained summary currently held, so a match with the actual population is not established. |
Full eligibility criteria, selection flow, Fried components, and actual baseline characteristics table |
Record the actual selection criteria, baseline Fried components, and comorbidities, and link the analysis denominator for the frail population of interest. |
| 5 |
Unverified |
Full text not readStored summary read |
N05 · Baseline statusAre baseline usual speed, nutrition, and deficiency status verified?Required |
Upper and lower limits for baseline usual gait speed, nutritional status, dietary NR/NAD precursors, and deficiency tests are unverified. The label frailty alone does not establish NR deficiency. |
Values related to baseline speed and deficiency in the original assessment question's identity are null. Data are unavailable to distinguish applicability according to the degree of baseline impairment and nutritional status. |
Data on baseline gait speed, nutrition and dietary assessment, deficiency testing, medications, and walking aids |
Specify baseline functional and nutritional measures, and, if an effect-modification analysis is needed, prespecify its rationale and analysis plan. |
| 6 |
Partly verified |
Full text not readStored summary read |
N06 · Planned doseDoes 2,000 mg/day represent a value for which the actual intake and dosing schedule are also verified?Required |
NADage's 2,000 mg/day is the planned daily NR amount. Amount per dose, daily frequency, dose escalation, basis for salt conversion, and actual intake are unverified. The conversion to 2 g/day in the original historical calculation is only a cross-check of mass units. |
The planned daily amount is retained, but it is not actual exposure. The unit conversion also does not verify equivalence in salt or active-moiety amount. |
Amount per dose, frequency, dose escalation, basis for salt conversion, and actual medication-taking and adherence records |
In the trial, collect records of each administration and adherence, discontinuations, and dose reductions, and distinguish the prespecified effect of assignment from analyses of actual exposure. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · Planned durationIs the 52-week plan linked to actual exposure, measurement, and follow-up after discontinuation?Required |
The plan specifies 52 weeks of treatment and assessment at week 52. Actual exposure duration and separate follow-up after discontinuation are unverified. The original gait-speed result at that time point is also unverified. |
The planned duration is known, but actual completion, exposure, and measurement times are unavailable. The plan cannot be read as evidence that long-term results or a maintenance effect exist. |
Records of actual initiation, discontinuation, the week 52 visit, observation windows, and follow-up after discontinuation |
Record visit windows, actual days of exposure, and missing data appropriate to the original question; if persistence is a separate objective, design follow-up after discontinuation separately. |
| 8 |
Partly verified |
Full text not readStored summary read |
N08 · Placebo comparisonAre the placebo composition, matching method, and common care in both groups verified?Required |
The official registration index describes a placebo-comparison plan. The fields for the placebo's exact composition, matching method, and common care in both groups are null or unverified. |
The comparator's name is verified, but it cannot be verified whether NR was the only actual difference or how blinding was implemented. |
Placebo composition, appearance/sensory matching, and rules for common medications, diet, exercise, and rehabilitation |
Disclose the placebo and common care, and record blinding for medication taking and assessment and differences in care between groups. |
| 9 |
Partly verified |
Full text not readStored summary read |
N09 · Allocation implementationAre the actual implementation and concealment of the randomized, double-blind plan verified?Required |
S01–S02 are retained as a randomized, double-blind, placebo-controlled plan. The full registration, actual allocation, concealment, baseline balance, and data on actual implementation and results have not been verified. |
The design description in the public plan alone does not verify the actual allocation process. Do not reassess unknown implementation as either unbiased or failed. |
Full protocol, allocation-sequence generation/concealment, and data on actual allocation and baseline balance |
Document the actual allocation sequence, concealment, blinding, and baseline characteristics, and report results for the selected effect of assignment. |
| 10 |
Unverified |
Full text not readStored summary read |
N10 · Measurement of usual speedAre the test distance, acceleration section, repetitions, and instrument for usual speed verified?Required |
The question concerns change in m/s at a usual, comfortable pace. The actual test distance, acceleration section, instrument, repetitions, walking aids, and assessor blinding are unverified. |
target_endpoint defines the measurement concept for the question, but protocol_details is null. Matching units or the word gait alone does not establish that the tests are identical. |
Usual-speed measurement manual, walking aids, assessors, repetitions, and unit definitions |
Standardize the usual gait-speed procedure and specify assessment time points, aids, assessor blinding, and repeated measurements. |
| 11 |
Partly verified |
Full text not readStored summary read |
N11 · 6-minute-walk boundaryIs NADage's 6-minute walk with concurrent sensors the same endpoint as usual speed over a short course?Required |
The public plan for NADage, the closest study, describes a 6-minute walk with concurrent sensor gait assessment. Whether this is an endpoint equivalent to usual short-course gait speed has not been verified. |
The endpoint's actual name in the plan is verified, but usual_gait_equivalence is not_verified. Creating usual gait speed from distance÷time does not resolve this gap. |
Definitions of the 6-minute walk/sensors and data on equivalence with the usual-speed test and separately reported results |
Measure the two tests separately, describe their protocols, units and observation windows, and report a usual gait speed estimate that matches the question. |
| 12 |
Partly verified |
Full text not readStored summary read |
N12 · Endpoint hierarchyAre the page's usual gait speed endpoint and its actual trial hierarchy as primary, secondary or post hoc verified?Required |
Usual gait speed is this page's single editorial endpoint. The investigator page describes the 6-minute walk and sensor assessment as primary, but the field for the hierarchy of usual gait speed within the actual trial is null. |
The two descriptions concern different things, so this alone is not designated a data conflict. The prespecified hierarchy and analysis plan for usual gait speed, and their agreement with the actual report, remain unverified. |
The hierarchy of usual gait speed and reasons for changes in dated registration histories, protocols and analysis plans |
Specify the hierarchy and analysis of usual gait speed in the advance plan, and compare the reasons for changes in the actual report together with their dates. |
| 13 |
Partly verified |
Full text not readStored summary read |
N13 · Planned sampleAre the planned 100 participants distinguished from the actual enrolled, randomized, completed and usual gait speed analysis counts?Required |
NADage's 100 participants are a planned count. Actual enrollment, randomization, completion and usual gait speed analysis counts remain unverified. |
The nature of the planned n is clear, but actual sample-flow data are unavailable. The 100 participants cannot be converted into a per-group n or an analysis denominator. |
Participant flow diagram; enrollment, allocation and completion by group; usual gait speed analysis denominators and reasons for exclusion |
Report the actual sample flow at each stage, the corresponding usual gait speed analysis n and reasons for missingness alongside the results. |
| 14 |
Unverified |
Full text not readStored summary read |
N14 · Current registry statusCan the latest recruitment and results-posting status as of the reference date be verified?Required |
The wording on the investigator page about recruitment starting is a historical record. S02's directly accessed body was a glossary-only application shell, and the latest status, registration history and posted results were not verified at that time. |
The registry was not accessed in the current work. Do not read the generic word Withdrawn in the shell seen at that time as this trial's withdrawal status, or conclude that no latest results exist. |
NCT06208527 registration history, status and posted results documents as of the relevant reference date |
Verification of suitable materials means linking registry versions and results documents to their dates at the time; it is distinct from conducting a new trial itself. |
| 15 |
Unverified |
Full text not readStored summary read |
N15 · Effect of interestAre the actual between-group analysis, ITT/PP and adjustment for usual gait speed verified?Required |
The question concerns the between-group difference in change in usual gait speed from baseline to 52 weeks under treatment assignment. The actual analysis population, ITT/PP, adjusted model and results remain unverified. |
The estimand in the original question identity is the requested question. It cannot automatically be elevated to an analysis performed in the actual trial. |
Documents defining the estimand of interest, analysis population, model, adjustment and actual results |
Prespecify the effect of interest, handling of missingness and adherence, and adjustment in the analysis plan, and report an estimate for that contrast. |
| 16 |
Unverified |
Full text not readStored summary read |
N16 · Missingness and attritionWho was missing from the 52-week speed measurement, and how was this handled?Required |
Actual completion and usual gait speed analysis counts and the reasons for missing measurements are not verified in the retained materials. Observation losses cannot be assessed solely from the planned 52 weeks and 100 participants. |
Without actual sample flow and analysis data, the adequacy of missing-data handling or completeness of follow-up cannot be judged. |
Missed visits, discontinuation, death/illness, inability to measure, handling of missingness and sensitivity analyses by group |
Report visit flow, including discontinuation, death and inability to measure, together with prespecified handling of missingness and sensitivity analyses. |
| 17 |
Unverified |
Full text not readStored summary read |
N17 · Target effect estimateAre direct usual gait speed changes, the between-group difference and CI verified?Required |
The original values, changes, between-group estimate and CI for directly eligible usual gait speed remain unverified. target_between_group_effect_mps and target_ci are null. |
The currently retained materials include plans and results for other questions. Failure to verify direct results does not mean that the effect is 0 or that all human research is absent. |
Group-specific original usual gait speed values/changes, between-group estimate and CI for the fixed population, exposure and time point |
An eligible study reports group-specific results for the defined usual gait speed test together with the estimate, CI and denominator for the selected contrast. |
| 18 |
Unverified |
Full text not readStored summary read |
N18 · Variance and intervalsAre the SD, SE, covariance and interval type for the target change verified?Required |
The analysis denominator and CI for the target result remain unverified. The manuscript states that it did not estimate or fill in the target CI, SD, SE or covariance. |
No observed variance is available for calculating a new standardized effect or precision. The one-sided 90% interval from PAD pertains to a different endpoint. |
Variance type, analysis n and model for usual gait speed change, and the reported between-group interval |
Disclose the variance type, denominator, interval construction and analysis model for the relevant usual gait speed result. |
| 19 |
Unverified |
Full text not readStored summary read |
N19 · Clinical importanceIs a clinically important between-group difference appropriate to this frail population and test verified?Required |
The applicable between-group MCID field is null. The original question separately requires a valid between-group estimate and an interpretation of clinical importance appropriate to the population and test. |
The clinical importance for this question cannot be determined from another gait test, a threshold for individual change or a planned participant count. Exclusion of an important benefit has not been verified either. |
Evidence for a clinically important between-group difference for the relevant frail population and usual gait speed protocol |
First justify the evidence for an important difference appropriate to the population, test and between-group contrast, then interpret it alongside the estimated interval. |
| 20 |
Partly verified |
Full text not readStored summary read |
N20 · Funding and provisionAre the plan's funding, product provision and authors' conflicts of interest directly verified?Supplementary; required for a claim of independence |
The record that S01 contains funding information and the relevant location are retained. Because no directly eligible result has been verified, the original independence axis is null. This retained summary contains no extracted values for the specific funding source, product provision or all author roles, so their content was not inferred. |
The existence and location of funding information are recorded, but the level of actual content in the current input is limited. Do not copy ChromaDex relationships from other NR trials as NADage's provision information. |
NADage's original funding information, product provision, author roles, and patent/employment/declared conflicts of interest |
Link funding, product provision and author roles to the results data, and verify the actual study families when claiming independent replication. |
| 21 |
Partly verified |
Full text not readStored summary read |
N21 · Studies and reportsAre plans, papers, registrations and corrections kept from being double-counted as independent trials of effect?Required |
The native evidence distinguishes NADage F01, NR-VETS F02, Orr MCI F03, the healthy-adult crossover F04 and NICE PAD F05. S01–S02, S03–S04 and S09–S10 are related reports within their respective families; retain the narrow original record that the number of directly eligible results is 0. |
The 5 family descriptions and 15 actual citations record existence; they are not counts of direct usual gait speed trials or unique participants. Within the S05–S07 range notation in evidence, individual S06/S07 citations are absent from the current list and must not be created. |
A mapping of report identifiers, native F01–F05 relationships, and eligible results/endpoints/time points |
When collecting materials, verify the relationships between registration numbers/DOIs and results/time points/analyses to link multiple reports of the same study. |
| 22 |
Not met |
Full text not readStored summary read |
N22 · Adjacent trial in prefrailtyIs the NR-VETS population the same as the selected frail population with Fried scores of 3 or higher?Required |
The institutional index for NR-VETS describes non-frail and prefrail participants, Fried<3. This does not match the Fried≥3 population criterion for this question, and the complete protocol and target results remain unverified. |
The population described in the currently retained index differs from the fixed question. This does not mean that NR-VETS has no efficacy or that exclusion of frail participants across all amended versions has been established. |
Complete NR-VETS eligibility criteria, amendment history and usual gait speed results by frailty stratum |
Verify separate results by frailty stratum in that study, or perform the same usual gait speed comparison in the selected Fried≥3 population. |
| 23 |
Not met |
Full text not readStored summary read |
N23 · Within-group MCI resultsAre Orr's two p-values a between-group effect on usual gait speed in frail participants?Required |
In Orr MCI, placebo p=0.0402 and NR p=0.4698 are tests of within-group walking-speed change in each group. They are not a between-group effect in m/s, and the clinical MCI eligibility criteria differ from the frailty eligibility conditions for this question. |
A difference in significance between the two within-group tests is not a test of the between-group effect. The target population, protocol and between-group estimate have not been verified, so these cannot be used as direct results. |
Orr's gait test, actual between-group m/s estimate/CI and results tables by population |
Report a direct between-group estimate appropriate to the population of interest and usual gait speed test, and distinguish it from within-group results. |
| 24 |
Partly verified |
Full text not readStored summary read |
N24 · MCI denominators and scheduleAre Orr's actual completion count, gait analysis denominator and dosing schedule verified?Required |
Orr’s abstract and figure captions record 20 completers. The total number randomized and the gait-outcome analysis denominator are unverified in this manuscript. The historical calculation cross-checking the phases 1+1+1+6 against 9 weeks records ambiguity in the abstract’s duration wording; it does not constitute a correction of the original table or a target 52-week result. |
Only the completed count and a cross-check of the historical schedule are available; an analysis count for the target population is absent. That calculation is not presented as a new clinical calculation or as confirmed actual treatment days. |
Orr’s participant flow by stage, gait-analysis n, dose escalation/treatment days, and data for the target frail population |
For adjacent evidence, verify the actual participant flow and analysis denominator in its original table; assess the target comparison using a separate eligible population and 52-week results. |
| 25 |
Not met |
Full text not readStored summary read |
N25 · Healthy-participant crossoverAre Martens’ motor-function results in healthy participants equivalent to the target frailty comparison?Required |
Martens’ crossover trial in healthy middle-aged and older adults reported no improvement in overall motor function. Baseline function and the regimen differ, and no target usual-speed values were reconstructed from the supplementary motor-function figures. |
The population and regimen differ from the fixed question of frailty, 2,000 mg/day, and 52 weeks. The adjacent trial’s no-difference result is retained, but it is not used as evidence that the target effect is 0. |
Exposure, duration, baseline function, usual-speed results, and crossover analysis in the healthy-participant crossover trial |
Verify results using the same frail population, exposure, and test; when using crossover data, report period, sequence, and carryover effects and a paired analysis. |
| 26 |
Not met |
Full text not readStored summary read |
N26 · Positive PAD resultIs NICE’s +17.6 m an effect on usual gait speed in m/s in the frail population?Required |
NICE PAD randomized 90 participants overall. The 6-month between-group result for 6-minute walk distance, +17.6 m, is a positive adjacent result. WIQ speed is a self-reported score; these values are not usual-gait-speed results in m/s for the target frail population. |
The positive signal is retained, but the population, endpoint, and time point differ from the fixed question. Do not use the 90 randomized overall as the analysis n for the target speed or calculate distance÷time. |
NICE’s original 6-minute-walk table and separate usual-speed results for the selected frail population |
Measure usual speed separately in the target frail population and report the selected contrast, time point, and denominator. |
| 27 |
Verified |
Full text not readStored summary read |
N27 · PAD interval and criterionAre NICE’s one-sided 90% CI and p=0.08 distinguished from its study-specific criterion?Required |
NICE’s adjacent distance result is a one-sided 90% CI [+1.77,+∞) m and p=0.08. The manuscript explains that it met the study’s prespecified significance criterion. It was not reclassified as a failure under a universal p<.05 criterion. |
The manuscript retains the interval type, lower bound, open upper bound, and explanation of the study-specific criterion. This does not mean that statistical or clinical success for the target usual speed has been verified. |
NICE’s prespecified statistical criterion, definition of the one-sided interval, and location of the original between-group report |
Future direct studies should disclose the prespecified statistical criterion, interval type, and contrast of interest alongside the results, distinguishing these from clinical importance. |
| 28 |
Partly verified |
Full text not readStored summary read |
N28 · Scope of the correction noticeAre the actual content of the NICE correction notice and its impact on the results verified?Required |
The record states that the existence and identifier of the 2024-08-12 NICE publisher correction were verified in the original article’s change history. The content of the correction notice was not acquired at that time. |
The existence of the correction notice is retained, but its body, what was changed, and its impact on the results are unverified. Do not automatically describe it as a retraction or a correction to an effect estimate. |
The original article’s change history, the full correction notice, and links between results/tables before and after the correction |
When reviewing materials, compare what the full correction notice changes with the original table and record it. This is a verification task distinct from designing a new clinical trial. |
| 29 |
Not met |
Full text not readStored summary read |
N29 · Other moleculesAre NMN, NAM, niacin, and tryptophan materials evidence for NR alone?Required |
S13 concerns tryptophan, nicotinic acid, and nicotinamide; S14 concerns NMN. The S17 NICE-FIT title contains nicotinamide. Candidates not verified as NR are not used as direct NR evidence. |
The retained substance identity differs from the requested NR or is not verified as NR. Positive gait results for NMN also do not verify a direct NR effect because the molecule differs. |
The actual active ingredient, product composition, endpoint, and population identity of candidate studies |
When checking study eligibility, verify the active molecule, salt, and composition, and design a separate direct study for the NR question. |
| 30 |
Not met |
Full text not readStored summary read |
N30 · Combination with exerciseIs the NR+exercise trial in hypertension a contrast of NR alone for gait speed in frailty?Required |
S15 is a pilot trial of NR+exercise in middle-aged and older adults with hypertension. The record is of screening at the level of the publisher’s abstract and bibliographic back matter; it was not counted as a direct replication of usual-speed results in the target frail population. |
The population and concurrent intervention in the screening record differ from the fixed question. Separation of exercise by arm and the target speed results were not verified. |
S15’s exercise requirements in both arms, NR contrast, frail stratum, and usual-speed results |
Specify the exercise common to both arms and the NR difference, or separate their contributions using a factorial design, and measure usual speed in the target frail stratum. |
| 31 |
Not met |
Full text not readStored summary read |
N31 · Species and combination productsDoes the combination-product cognition study in senior dogs address the NR gait question in older humans?Required |
S18 concerns a senolytic/NAD-precursor combination and owner-assessed cognition in senior dogs. It was excluded at screening because the species, intervention, and endpoint differ, and no dog effect estimates were used. |
The actual question in the archived bibliographic record differs from the selected question about gait with NR alone in humans. The title/abstract screening record is not a refutation of human research. |
S18’s species, active ingredients, and measured outcomes, and direct evidence in humans |
A direct comparison with the target human population, exposure to the single intervention, and a usual-speed test is needed. |
| 32 |
Unverified |
Full text not readStored summary read |
N32 · Mechanism and functionAre direct usual-speed results verified separately from NAD increases, SPPB, strength, and fatigue?Required |
NAD increases, SPPB, chair rises, strength, fatigue, and usual gait speed are different outcomes. P on the original axis denotes a functional endpoint performed by the patient; it does not mean that a direct effect has been verified. |
Signals from other measures or the existence of a functional-test battery cannot fill in the between-group difference for the target usual speed. That direct value is currently null. |
A report distinguishing direct results for the target usual speed from other functional and biochemical results |
Measure the selected usual speed separately from mechanisms and other functions, and prespecify and report each contrast of interest. |
| 33 |
Unverified |
Full text not readStored summary read |
N33 · Harms for the target questionAre events, discontinuations, and denominators verified for this plan in the frail population at 2,000 mg/day for 52 weeks?Supplementary; required for expansion to safety |
Adverse events, discontinuations, and long-term safety are unverified for the high-dose, long-term plan in the target frail population. Caution in the original safety label does not mean that NR harm has been established. |
Event frequency or causality cannot be assessed because records are absent for event definitions, systematic/spontaneous collection, exposure denominators, temporal order, discontinuation/recovery, between-arm comparisons, other causes, and missing data. |
Arm-specific AE/SAE, numbers of people and events, discontinuations, collection periods, and collection methods for the same population, product, and exposure |
In long-term comparisons, collect event definitions, collection schedules, discontinuations, exposure time, concomitant treatments, and arm-specific numbers of people and events. Consider follow-up designs suited to rare events separately. |
| 34 |
Not met |
Full text not readStored summary read |
N34 · Scope of official safety assessmentsDoes EFSA’s assessment of specified NR chloride for use at 300 mg/day in healthy adults guarantee safety for the target question?Supplementary; required for expansion to safety |
S11/S12 are official safety and use assessments of specified NR chloride. Assessment of use at 300 mg/day in healthy adults is neither a safety guarantee for this frail population’s plan of 2,000 mg/day for 52 weeks nor approval of walking efficacy. |
The populations, substances, and conditions of use in the official materials are not equivalent to direct safety information for the target plan. The manuscript also did not copy nicotinic-acid flushing or hepatic harm to NR. |
The substance, use amount, population, and duration in the EFSA assessment, and direct safety data from the target trial |
Separately review long-term safety follow-up appropriate to the target product, dose, and frail population, along with data on concomitant treatments and vulnerable groups. |
| 35 |
Unverified |
Full text not readStored summary read |
N35 · Actual concomitant treatments and adherenceAre arm-specific changes in medicines, diet, exercise, rehabilitation, and dose reduction/discontinuation verified?Required |
Policies for common medicines, diet, exercise, and rehabilitation in both arms, and actual dosing frequency, dose escalation, adherence, and changes, are unverified. Do not attribute effects of other medicines or rehabilitation to NR. |
The full registration and actual implementation records have not been verified, so the effects of concurrent changes and discontinuations cannot be assessed. Do not fill these gaps with an absence of concomitant treatment or completed medication use. |
Lists and timing of concomitant treatments in both arms, medication adherence, dose reduction/discontinuation, rescue treatment, and analytical handling |
Collect the timing of medication changes and concurrent treatments, and explicitly distinguish the effect of assignment, the effect of adherence, and attribution of harms. |
| 36 |
Not applicable |
Full text not readStored summary read |
N36 · Extension to dose and persistenceDoes the claim also extend to the optimal dose, maintenance after discontinuation, and effects in other frailty strata?Supplementary; required for extended claims |
The current table concerns usual speed under the planned conditions of 2,000 mg/day, 52 weeks, and Fried≥3. It does not establish the optimal dose, persistence after discontinuation, or effects across all frailty strata at the same time. |
Extended claims are outside the scope of this independent question. Not applicable does not mean that those extended effects are absent or that external full text has been read. |
Direct dose comparisons, follow-up after discontinuation, and prespecified subgroup/interaction data needed when making such extended claims |
If a new extension question is requested, first define separate questions and plans for dose comparisons, follow-up after discontinuation, and effect modification. |
| 37 |
Not applicable |
Full text not readStored summary read |
N37 · Extension to clinical eventsDoes the claim also encompass prevention of falls, hospitalization, and death, and improvement in quality of life?Supplementary; required for extension to clinical events |
The original question concerns usual walking function itself. Prevention of falls, hospitalization, and death, and improvement in quality of life are not adjudicated together with it. |
Separate clinical events are outside the fixed question. This boundary of non-applicability does not imply an absence of effects on those events, nor does it remove the necessary conditions for the current speed outcome. |
Event definitions, observation windows, comparison denominators, and direct estimation data required when making claims about those events |
If event prevention becomes a new question, a design with definitions, follow-up, denominators, and comparisons for those events is reviewed separately. |
| 38 |
Verified |
Full text not readStored summary read |
N38 · Search scope and 0Do 0 direct results and no_human_study mean that all human NR research amounts to 0?Required |
In the logged search as of 2026-09-15, no directly eligible result for the fixed question was verified; that is the meaning of the original 0. human_NR_trials_exist=true and no_human_study=true coexist; the latter has the narrow meaning of a gate for calculator compatibility. |
The original grade_semantics specifies the scope. The original ? and null score are preserved, without carrying them over as this table's verification status, an efficacy probability, or a new judgment. |
The original search reference date, selection records, and explicit scope within which directly eligible results were checked |
Future evidence updates retain the same boundaries, search dates, and eligibility records, and distinguish new results from existing plans and other outcomes. |
| 39 |
Verified |
Full text not readStored summary read |
N39 · Reading of materialsAre the currently preserved archived summaries distinguished from external access and full-text reading at that earlier time?Required |
This time, the entire KO/EN text, structure, bibliography, and history of the preserved archived summaries, identical to the current source, were read. Report-specific access records dated 2026-09-15 for official indexes, application shells, abstracts, figure legends, HTML, and correction metadata are historical records. External materials have not been accessed or read this time; access has not been attempted. |
The scope of the current summary reading and the attribution of the historical access descriptions were checked. The existence of publisher, PMC, and official links is distinguished from having read the full text now. |
Each report's actual material type, original address, current access-not-attempted/unread status, historical access_level/date, and original location |
When materials are acquired, their original locations, access events, dates, and material types are recorded by report, and original summaries are distinguished from directly obtained full texts. This is a method for reviewing materials, separate from a clinical trial proposal. |
| 40 |
Verified |
Full text not readStored summary read |
N40 · Preservation of historyWere the original ?, null values, axes, calculations, and publication metadata preserved without a new judgment?Required |
Record from the time the preservation table was prepared: The original grade ?, null score, B/P, unscored axes, compatibility boolean, 4 historical arithmetic calculations, document self-review, and publication reference date are preserved. In that record, the original deployed_at was null, and the map current at that time was also not publicly deployed. |
Preservation of the original values is neither a new efficacy judgment nor document-quality certification. The preserved arithmetic was performed at that earlier time; no new clinical calculations were performed this time. |
The exact original values for the original judgment, unscored axes, historical arithmetic, document quality, and manuscript publication/deployment metadata |
Future updates preserve the source bytes before and after changes and the reasons for changes, and distinguish changes in conditions, additions of materials, and new publication events. |