{ "schema_version": "chamgap-public-criteria-1.0", "title": "Single-ingredient oral ordinary thiamine (vitamin B1) × Endurance time-trial completion time in trained adults", "criteria_version": "v3119-ORAL-THIAMINE-TRAINED-TT-1.1", "criteria_date": "2026-10-05", "condition_origin": "Chamgap application criteria", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "Historical reuse of actual method HTML copies/SHA from 1585 and the principles recorded at that time. This is not new reading of complete method texts or official implementation/certification." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "Historical reuse of actual method HTML copies/SHA from 1585 and the principles recorded at that time. This is not new reading of complete method texts or official implementation/certification." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Historical reuse of actual method HTML copies/SHA from 1585 and the principles recorded at that time. This is not new reading of complete method texts or official implementation/certification." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Historical reuse of actual method HTML copies/SHA from 1585 and the principles recorded at that time. This is not new reading of complete method texts or official implementation/certification." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "Historical reuse of actual method HTML copies/SHA from 1585 and the principles recorded at that time. This is not new reading of complete method texts or official implementation/certification." } ], "status_dictionary": { "Met": "Meeting narrow record criteria, such as identity, exclusion/attribution, original verdicts, and current versus historical reading. This is not verification of clinical efficacy/safety or complete external texts.", "Partly verified": "Some actual retained reports exist, but verification of original methods, denominators/dispersion, implementation, plans/access remains outstanding.", "Unverified": "The required values/materials cannot be established from the current inputs and the historical verification scope. Distinguish unverified information in the materials from actual review still outstanding.", "Not reported": "Limited to non-reporting in specific materials/sections actually read; not extended to complete external texts that have not been read.", "Conflicting information": "Used only when incompatible records of the same fact have actually been verified. S04's dose ambiguity and differences between trials/formulations/endpoints are not turned into newly confirmed conflicts.", "Inaccessible": "Used only when actual external access has failed in this review. External access was not attempted and external materials were not read in this review; historical failures are not inherited.", "Review incomplete": "Means external materials have not been cross-checked in this review or actual work remains outstanding. Unverified information in materials already reviewed within the limited scope is not labeled as failure of the entire review.", "Not applicable": "Not applicable to establishing long-term outcomes/optimal dose, personal application or regulatory compliance outside the narrow TT question. This is not certification of absence of studies, no effect or safety for those questions." }, "requirements": [ { "item_id": "N01", "question_type": "Independent question", "question": "What is the performance-efficacy question in this table?", "needed": "The identity of the current claim and the boundaries of the population, single-ingredient oral exposure, matched control and completion time", "role": "Required", "role_reason": "Needed to avoid combining the entire B1 family or all exercise performance into one verified effect.", "application_exception": "The subclaim array is empty. Reports on related derivatives, combinations and other endpoints are not split into new primary tables of direct evidence.", "criterion": "Preserve the exact /ko/effect and link it to one question about trained adults, single-ingredient oral ordinary thiamine and fixed-distance/work completion time.", "basis": "C01: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are locally designed / C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed. Reason for application in this case: Needed to avoid combining the entire B1 family or all exercise performance into one verified effect. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original claim with the actual population, intervention, control and endpoint, and record the inclusion/exclusion boundaries." }, { "item_id": "N02", "question_type": "Scope of eligible materials", "question": "What is the verification scope of 0 directly eligible families?", "needed": "The original search/access scope, candidate-specific grounds for inclusion/exclusion, and whether eligible results exist", "role": "Required", "role_reason": "Needed to avoid turning an unverified direct comparison into worldwide absence of studies, an effect of 0 or absence of human research.", "application_exception": "The existence of related human research differs from the existence of a trial eligible for the selected question about thiamine alone.", "criterion": "Preserve 0 directly eligible families together with any_human_study=true and absence_proven=false.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a local application / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; local application. Reason for application in this case: Needed to avoid turning an unverified direct comparison into worldwide absence of studies, an effect of 0 or absence of human research. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "In an authorized update, recheck question-specific selection criteria, candidate-specific reasons for inclusion/exclusion and the search scope." }, { "item_id": "N03", "question_type": "Identity of ordinary thiamine", "question": "Which salts/products qualify as single-ingredient ordinary thiamine?", "needed": "Verification of the free base/hydrochloride/mononitrate identity, product, batch, manufacturing source and single-ingredient composition in an eligible trial", "role": "Required", "role_reason": "Needed to avoid using the shared B1 label as evidence of molecular/product equivalence or an effect of the ingredient alone.", "application_exception": "Allithiamin, TTFD/fursultiamine, TPP and combinations do not substitute for ordinary thiamine alone. The free base/hydrochloride/mononitrate are not automatically pooled either.", "criterion": "Distinguish single-ingredient oral ordinary thiamine in the original question from the unverified actual salt/product, and do not create converted derivative doses.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid using the shared B1 label as evidence of molecular/product equivalence or an effect of the ingredient alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the product's ingredient list with the trial's actual formulation and supply/batch records to establish the exposure to include." }, { "item_id": "N04", "question_type": "Trained population", "question": "Adults from which sport and with which training criteria are targeted?", "needed": "Sport, training qualifications, competition level, training volume/years, age/sex and inclusion/exclusion criteria in an eligible trial", "role": "Required", "role_reason": "Needed to avoid transferring data from highly trained cyclists or non-athletes to all trained adults.", "application_exception": "Mean VO2max is not a training eligibility threshold. The female group with physical-education/Taekwondo experience is not relabeled as untrained.", "criterion": "Separate the trained adults specified in the question, the actual population of each trial, and the unverified eligible sport/qualifications.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / E08: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are locally designed. Reason for application in this case: Needed to avoid transferring data from highly trained cyclists or non-athletes to all trained adults. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare recruitment, baseline characteristic tables and training qualifications, and record differences in applicability across sports." }, { "item_id": "N05", "question_type": "Baseline nutritional status", "question": "Have deficiency correction and performance in trained adults with different nutritional status been distinguished?", "needed": "Baseline thiamine markers/assays, thresholds, diet/energy availability, concomitant supplementation and deficiency-related selection", "role": "Required", "role_reason": "Needed to avoid extending deficiency improvement or blood-level categorization to additional performance benefits in nutritionally sufficient athletes.", "application_exception": "S03's blood-level division at 40 ng/mL is the authors' classification, not a universal diagnostic criterion for deficiency. A request to follow a normal diet does not verify adequate baseline B1.", "criterion": "Preserve unverified eligible baseline status and the limitations of markers/diet in related trials, and separate deficiency treatment from the performance question.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application / E08: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are locally designed. Reason for application in this case: Needed to avoid extending deficiency improvement or blood-level categorization to additional performance benefits in nutritionally sufficient athletes. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare baseline testing and diet/concomitant supplementation records with the presence of prespecified stratification or interaction analyses." }, { "item_id": "N06", "question_type": "Dose and frequency", "question": "What are the actual dose and administration frequency of an eligible single-ingredient product?", "needed": "Actual salt/active amount, dose per administration (1 time), total daily dose, frequency, meal timing/loading, adherence and concomitant exposure", "role": "Required", "role_reason": "Needed to avoid transferring a derivative or combination dose to a study dose or personal recommended dose for ordinary thiamine alone.", "application_exception": "Derivative mass is not converted to a thiamine-equivalent dose. Reported amounts of other products are attributed only to those products.", "criterion": "Retain null for eligible dose/frequency, and link doses and ambiguities in related reports to separate rows.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application / E08: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are locally designed. Reason for application in this case: Needed to avoid transferring a derivative or combination dose to a study dose or personal recommended dose for ordinary thiamine alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare actual administration with ingredient/active-amount records, and analyze any dose comparison as a separate prespecified question." }, { "item_id": "N07", "question_type": "Duration and time point", "question": "Which completion time after which supplementation duration is being compared?", "needed": "Eligible supplementation duration, actual exposure, principal measurement time point, discontinuation/follow-up and reasons for selecting the duration", "role": "Required", "role_reason": "Needed to avoid pooling results after 3/4/7 days or 4 weeks with different formulations as effects at the same time point or sustained effects.", "application_exception": "Long-term studies are not unconditionally imposed as a requirement for a short completion-time question; long-term persistence of effects is a separate question.", "criterion": "Distinguish null eligible duration/principal time point from each duration/time point in related reports.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / E08: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are locally designed. Reason for application in this case: Needed to avoid pooling results after 3/4/7 days or 4 weeks with different formulations as effects at the same time point or sustained effects. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the administration schedule, measurement time points and planned principal time point, and design additional follow-up as a separate question about persistence." }, { "item_id": "N08", "question_type": "Control and concomitant treatments", "question": "Are other treatments matched, with only added thiamine differing?", "needed": "Eligible control ingredients, diet/hydration/caffeine, training, concomitant supplementation, adherence/rescue treatment and changes by group/period", "role": "Required", "role_reason": "Needed to avoid attributing differences in diet, training or combined ingredients to an effect of thiamine alone.", "application_exception": "Do not require all treatment changes to be identical; distinguish the actual effect of interest and how changes are handled. A placebo label alone does not verify matching.", "criterion": "Separate the matched control specified in the question from the unverified actual eligible control/concomitant treatments.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid attributing differences in diet, training or combined ingredients to an effect of thiamine alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare control composition, diet/training by period, concomitant exposure and adherence records to examine the contribution of the single ingredient." }, { "item_id": "N09", "question_type": "Completion-time definition", "question": "Have fixed-distance/work completion time and time to exhaustion been distinguished?", "needed": "Eligible sport, fixed distance/work, principal completion time, unit, direction and prespecified endpoint definition", "role": "Required", "role_reason": "Needed to avoid transferring completion time, for which shorter is better, and time to exhaustion, for which longer is better, into the same outcome.", "application_exception": "Biochemistry/RPE during fixed 60-minute exercise, VO2max, lactate and subjective fatigue are not substitutes for completion time.", "criterion": "Retain lower_is_better=true for the selected endpoint and the unverified actual eligible protocol/unit, and separate outcomes with a different direction.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / E03: M08 Table 8.2.a, M03 §3.2.4; local application / E09: M03 §3.2.4; locally defined boundaries for extensions. Reason for application in this case: Needed to avoid transferring completion time, for which shorter is better, and time to exhaustion, for which longer is better, into the same outcome. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare distance/work, stopping criteria, units and the prespecified endpoint list, and link only comparable completion times." }, { "item_id": "N10", "question_type": "Measurement implementation", "question": "Were measurement conditions and learning effects from repeated testing controlled?", "needed": "Familiarization, warm-up, pacing, resistance/gradient, environment, equipment calibration, encouragement, time of day, hydration/feeding/caffeine", "role": "Required", "role_reason": "Needed because even objective records in seconds can be affected by differences in measurement implementation and learning effects across periods.", "application_exception": "Do not automatically judge objective records to be unbiased or fill unverified measurement procedures in as properly implemented.", "criterion": "Link unverified eligible implementation information and limitations of related reports to their locations.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / E03: M08 Table 8.2.a, M03 §3.2.4; local application. Reason for application in this case: Needed because even objective records in seconds can be affected by differences in measurement implementation and learning effects across periods. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the measurement SOP with actual equipment/environment, familiarization and period-specific implementation records." }, { "item_id": "N11", "question_type": "Allocation process", "question": "Have actual allocation and concealment in the eligible comparison been verified?", "needed": "Parallel/crossover design, random sequence, allocation concealment and baseline/sequence balance in the selected comparison", "role": "Required", "role_reason": "Needed to avoid inheriting a related trial's randomized label as verification of allocation for causal inference in an as-yet-unselected eligible trial.", "application_exception": "Preserve the designs of related ineligible trials, but do not score bias in the effect of an eligible single-ingredient product on those designs alone.", "criterion": "Distinguish the absence of a selected eligible trial from unverified actual allocation/concealment, and assign no new RoB grade.", "basis": "E01: M08 §8.1–8.2.3; local application / C04: M03 §3.2.1; detailed population criteria are locally designed. Reason for application in this case: Needed to avoid inheriting a related trial's randomized label as verification of allocation for causal inference in an as-yet-unselected eligible trial. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the eligible protocol, sequence generation/concealment, and baseline and sequence-specific characteristics." }, { "item_id": "N12", "question_type": "Blinding", "question": "Have the actual blinding procedures and their success been verified?", "needed": "Participant/assessor blinding, placebo matching, actual unblinding and assessment of blinding", "role": "Required", "role_reason": "Needed to avoid turning a double-blind label into actual successful blinding or the absence of differences in encouragement/assessment.", "application_exception": "Inability to blind is not automatically judged a failure. S05's manufacturer assistance with placebo/blinding is recorded alongside its separate funding/product roles.", "criterion": "Separate unverified eligible blinding from the levels of verification/non-verification in related trials.", "basis": "E01: M08 §8.1–8.2.3; local application / E03: M08 Table 8.2.a, M03 §3.2.4; local application. Reason for application in this case: Needed to avoid turning a double-blind label into actual successful blinding or the absence of differences in encouragement/assessment. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare placebo composition, blinding implementation/unblinding, assessor roles and verified assessments." }, { "item_id": "N13", "question_type": "Eligible denominators", "question": "Who was allocated, analyzed, completed or dropped out?", "needed": "Eligible allocation/analysis/completion, period-specific dropout, exclusions, analysis populations and reasons", "role": "Required", "role_reason": "Needed to avoid turning reported participant counts or repeated periods into eligible analysis denominators.", "application_exception": "Do not replace null direct results with 0 participants. Participant counts in S01/S02 do not represent separately verified analysis flow.", "criterion": "Retain null for eligible randomized_n/analyzed_n/completed_n and record what the related reported counts represent.", "basis": "C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E04: M08 §8.2.2, M15 §15.3.1; local application. Reason for application in this case: Needed to avoid turning reported participant counts or repeated periods into eligible analysis denominators. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare participant flow, those analyzed by period and reasons for missingness/exclusion to verify endpoint-specific denominators." }, { "item_id": "N14", "question_type": "Effect of interest in a crossover", "question": "Have pairing, period and carryover effects in the crossover trial been verified?", "needed": "Eligible effect of interest, sequence/period, washout, handling of carryover/learning, adherence, analysis model and paired variance", "role": "Required", "role_reason": "Needed to avoid converting marginal crossover summaries into an effect between two independent groups or a paired effect/CI.", "application_exception": "Do not replace an unverified eligible design with a designation that crossover design is not applicable. Preserve unique participants in ineligible crossover results.", "criterion": "Explain the unverified eligible estimand/model and the lack of pairing/carryover information in related crossovers.", "basis": "E04: M08 §8.2.2, M15 §15.3.1; local application / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed. Reason for application in this case: Needed to avoid converting marginal crossover summaries into an effect between two independent groups or a paired effect/CI. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original analysis plan with individual period/sequence data to assess the effect of interest and the suitability of handling period/carryover effects." }, { "item_id": "N15", "question_type": "Direct effect", "question": "Has a completion-time effect of single-ingredient ordinary thiamine versus control been reported?", "needed": "Eligible endpoint-specific effect, CI/confidence level, P, unit, denominator and original table/model", "role": "Required", "role_reason": "Needed to avoid moving derivative or combination values into the primary-effect field and making a direct effect appear verified.", "application_exception": "Unverified null is not replaced with an effect of 0 or P=1, and indirect values are not pooled or subjected to new arithmetic.", "criterion": "Retain null for effect/CI/P/unit/n in primary_result and the eligible fact_capsule.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E04: M08 §8.2.2, M15 §15.3.1; local application / E05: M15 §15.3.1–15.3.3; local application. Reason for application in this case: Needed to avoid moving derivative or combination values into the primary-effect field and making a direct effect appear verified. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Directly cross-check eligible original tables against the definition, denominator, unit and reported intervals of the model for the effect of interest." }, { "item_id": "N16", "question_type": "Precision and importance", "question": "Can a nonsignificant result be interpreted as no effect or equivalence?", "needed": "The eligible effect's CI, paired variance, prespecified important-difference/equivalence criteria and supporting justification", "role": "Required", "role_reason": "Needed to avoid establishing an effect size as sufficient, absent or equivalent from P values and small sample sizes alone.", "application_exception": "Do not invent an unsupported common MCID, minimum n, number of trials or duration. Do not fill in unverified parenthetical dispersion as SD/SE.", "criterion": "Separate nonsignificance at P=0.58/0.61 from absence of effect/equivalence, and retain unverified direct precision/importance.", "basis": "E05: M15 §15.3.1–15.3.3; local application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed. Reason for application in this case: Needed to avoid establishing an effect size as sufficient, absent or equivalent from P values and small sample sizes alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare reported intervals with verified prespecified criteria for performance importance, and record the limits to interpretation." }, { "item_id": "N17", "question_type": "S01 product and population", "question": "What are the product and exposure in the closest report on trained cyclists?", "needed": "S01's original formulation, composition, administration, trained population/baseline characteristics and information on the ingredient's contribution alone", "role": "Required", "role_reason": "Needed to avoid relabeling a derivative combination as a trial of ordinary thiamine alone because it is a TT in a closely related trained population.", "application_exception": "ordinary_thiamine=false denies the product's eligibility as single-ingredient ordinary thiamine; it does not mean the combination contains no B1-family ingredient.", "criterion": "Link the allithiamin+pantothenic-acid-related combination, reported dose/7 days, trained cyclist population and reasons for exclusion.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid relabeling a derivative combination as a trial of ordinary thiamine alone because it is a TT in a closely related trained population. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original product/methods with the existence of an actual contrast that isolates the ingredient's contribution." }, { "item_id": "N18", "question_type": "S01 TT values", "question": "Have the status of S01's time summaries and historical arithmetic been preserved?", "needed": "S01's original TT protocol, numerical sentence, mean/dispersion type, paired analysis/CI and flow", "role": "Required", "role_reason": "Needed to avoid promoting marginal summaries and the simple difference recorded at retention into a direct ordinary-thiamine effect or paired estimate.", "application_exception": "Do not infer that the parenthetical 8.4/10.2 are SD or SE. −7.5 seconds is historical descriptive arithmetic, not a new calculation in this review.", "criterion": "Preserve the 50 km preload followed by a 2,000 m TT, 178.2(8.4)/170.7(10.2) seconds, P=0.58 and reported n=6 together with unverified dispersion/CI.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E04: M08 §8.2.2, M15 §15.3.1; local application / E05: M15 §15.3.1–15.3.3; local application. Reason for application in this case: Needed to avoid promoting marginal summaries and the simple difference recorded at retention into a direct ordinary-thiamine effect or paired estimate. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original numerical sentence, endpoint time point and paired model/variance materials to distinguish descriptive summaries from the effect of interest." }, { "item_id": "N19", "question_type": "S02 formulation and exposure", "question": "How are S02's TTFD dose, duration and route distinguished?", "needed": "S02 TTFD identity, product, administration route, daily dose/duration, washout and actual training criteria", "role": "Required", "role_reason": "Needed to avoid transferring a TTFD dose or the label supplement into verification of oral ordinary-thiamine exposure.", "application_exception": "The route is null in the original structure. Oral administration is not inferred from the word supplementation or from the washout.", "criterion": "Preserve TTFD 1 g/day, 4 days per period and a 10-day washout, with unverified route/training qualifications.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid transferring a TTFD dose or the label supplement into verification of oral ordinary-thiamine exposure. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original administration methods and selection/training criteria, and record eligibility differences from ordinary thiamine alone." }, { "item_id": "N20", "question_type": "S02 timing and values", "question": "Are S02's TT and the preceding day's exhaustion test the same endpoint?", "needed": "Definitions and values/central tendency, dispersion/denominators and paired analyses for S02's day 4 TT and day 3 progressive exhaustion test", "role": "Required", "role_reason": "Needed to avoid pooling different tests and nonsignificant time summaries in the same paper as one direct performance effect.", "application_exception": "The 14 are unique reported participants; the two crossover periods are not counted as 28 people. Whether the parenthetical 5.5/4.3 are SD/SE is unverified.", "criterion": "Separate the day 4, 2,000 m TT values of placebo 204.5(5.5) seconds, TTFD 200.9(4.3) seconds and P=0.61 from the day 3 exhaustion test.", "basis": "C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E04: M08 §8.2.2, M15 §15.3.1; local application / E05: M15 §15.3.1–15.3.3; local application. Reason for application in this case: Needed to avoid pooling different tests and nonsignificant time summaries in the same paper as one direct performance effect. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original schedule with each endpoint's numerical sentence, denominator and paired model to attribute results to their respective tests." }, { "item_id": "N21", "question_type": "S03 fatigue and blood-level classification", "question": "Is S03's favorable fatigue report a completion-time effect?", "needed": "S03 original formulation/route, blood-level classification, fatigue/biochemical measurements, values and whether a standardized TT exists", "role": "Required", "role_reason": "Needed to avoid omitting favorable fatigue/metabolic reports or transferring them into a direct positive effect on fixed-distance completion time.", "application_exception": "Distinguish the keyword fursultiamine/TTFD from the unverified product in the full text. The blood-level division at 40 ng/mL is not a universal diagnostic criterion for deficiency.", "criterion": "Preserve the 16 male athlete volunteers, 100 mg/day for 3 days, and the authors' blood-level classification/favorable fatigue report, while leaving route and standardized TT effect unverified.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / E09: M03 §3.2.4; locally defined boundaries for extensions. Reason for application in this case: Needed to avoid omitting favorable fatigue/metabolic reports or transferring them into a direct positive effect on fixed-distance completion time. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare original product/methods, classification criteria and fatigue/metabolic results, and verify their differences from the completion-time endpoint." }, { "item_id": "N22", "question_type": "S04 population and other endpoints", "question": "What are the results in S04's female population with athletic experience?", "needed": "S04 selection/athletic experience, crossover periods, TTFD/training/placebo, fixed-duration measurements and each result", "role": "Required", "role_reason": "Needed to avoid mislabeling a population with athletic experience as untrained or turning biochemical/RPE results into a completion-time effect.", "application_exception": "The training and TTFD periods are separate crossover treatments. Do not assign the TT completion-time direction to a fixed 60-minute test.", "criterion": "Distinguish the 9 women, physical-education/athletic and Taekwondo experience, oral TTFD, and biochemistry/RPE during fixed 60-minute exercise.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application / E09: M03 §3.2.4; locally defined boundaries for extensions. Reason for application in this case: Needed to avoid mislabeling a population with athletic experience as untrained or turning biochemical/RPE results into a completion-time effect. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare selection criteria, the three crossover treatments and measurement schedule/stopping criteria to verify the attribution of each result." }, { "item_id": "N23", "question_type": "S04 dose ambiguity", "question": "Can S04's 10 mg/kg and three administrations be converted?", "needed": "S04 original dose sentence, dose per administration (1 time)/total daily dose, actual administration and product/duration records", "role": "Required", "role_reason": "Needed to avoid repairing an ambiguous dose expression into an arbitrary daily dose or thiamine-equivalent dose.", "application_exception": "Do not multiply 10 mg/kg by 3 or by mean body weight based on the wording three administrations. Do not turn ambiguity into a newly established conflict between verified opposing facts.", "criterion": "Retain the records of 10 mg/kg, three administrations, 30 minutes after meals/150 mL water and 4 weeks, together with unverified total dose/dose per administration (1 time).", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid repairing an ambiguous dose expression into an arbitrary daily dose or thiamine-equivalent dose. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original dose sentence with actual administration records to verify the definitions of total daily dose and divided amounts." }, { "item_id": "N24", "question_type": "S05 combination composition", "question": "Does S05's B1 content constitute a contrast of added B1 alone?", "needed": "All Ex PLUS ingredients/salts, product, daily tablets, duration, concomitant exposure and a contrast isolating the ingredient's contribution", "role": "Required", "role_reason": "Needed to avoid reattributing an effect of a combination containing B1 to B1 alone.", "application_exception": "ordinary_thiamine=false denies eligibility as single-ingredient ordinary thiamine; it does not mean that no B1 molecules are present.", "criterion": "Preserve all reported ingredients in addition to B1 33.6 mg, and label it as a combination product taken at 1 tablet daily for 28 days per period.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; local application. Reason for application in this case: Needed to avoid reattributing an effect of a combination containing B1 to B1 alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare all ingredient/product records with the actual control to examine whether the trial isolated the contribution of a single ingredient." }, { "item_id": "N25", "question_type": "S05 denominator and time to exhaustion", "question": "How are S05's 32 participants and time to exhaustion preserved?", "needed": "Unique participants, sequence/period, washout, non-athlete selection, and the exhaustion result's mean/SD/direction and CI", "role": "Required", "role_reason": "Needed to avoid counting two periods as 64 people or displaying time to exhaustion, for which longer is better, as a TT, for which shorter is better.", "application_exception": "Combination results in non-athletes are not a direct effect of a single-ingredient product in trained adults. Reported SD is retained but not transferred to a paired SD/CI.", "criterion": "Attribute the 32 unique participants, initial sequences of 16/16, 14-day washout, and placebo 12.56±1.9 minutes/combination 15.82±1.91 minutes with P<0.0001 to the respective exhaustion endpoint.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E04: M08 §8.2.2, M15 §15.3.1; local application / E05: M15 §15.3.1–15.3.3; local application. Reason for application in this case: Needed to avoid counting two periods as 64 people or displaying time to exhaustion, for which longer is better, as a TT, for which shorter is better. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare participant flow and crossover schedule with the units, direction and dispersion in Figure 4/results." }, { "item_id": "N26", "question_type": "S05 analysis", "question": "Can repeated-measures ANOVA and marginal SD establish a paired effect?", "needed": "S05 SAP, repeated-measures/period/sequence/carryover model, Bonferroni/multiplicity and paired variance/CI", "role": "Required", "role_reason": "Needed to avoid turning a significant combination exhaustion result into verification of adequate paired estimation or direct precision.", "application_exception": "Do not generalize the record of some unpaired between-group tests to the analysis of every endpoint. Paired variance differs from marginal SD.", "criterion": "Distinguish two-way repeated-measures ANOVA+Bonferroni for exhaustion from unverified actual period/carryover handling and paired CI.", "basis": "E04: M08 §8.2.2, M15 §15.3.1; local application / E05: M15 §15.3.1–15.3.3; local application / E06: M08 Table 8.2.a, M04 §4.6.3; local application. Reason for application in this case: Needed to avoid turning a significant combination exhaustion result into verification of adequate paired estimation or direct precision. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original model for the exhaustion result with the SAP and period/sequence data to verify the scope of the paired structure and handling of multiplicity." }, { "item_id": "N27", "question_type": "S06 TPP and physiological endpoints", "question": "Are S06's TPP and physiological results an oral ordinary-thiamine TT?", "needed": "TPP product, 1 mg/kg administration schedule/route, saline control, training qualifications and physiological endpoints", "role": "Required", "role_reason": "Needed to avoid inferring that TPP and a saline control verify oral ordinary thiamine or transferring physiological results to completion time.", "application_exception": "Do not infer administration route from a 0.9% saline control alone. The 27 are reported participants; separate analysis flow is unverified.", "criterion": "Preserve TPP 1 mg/kg, unverified route/schedule, lactate/VO2max/heart-rate results and an unverified standardized TT.", "basis": "C04: M03 §3.2.1; detailed population criteria are locally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / E09: M03 §3.2.4; locally defined boundaries for extensions. Reason for application in this case: Needed to avoid inferring that TPP and a saline control verify oral ordinary thiamine or transferring physiological results to completion time. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original product, administration methods and physiological measurements/schedule to record eligibility differences in exposure and outcomes." }, { "item_id": "N28", "question_type": "Study families", "question": "Have reports been distinguished from counts of unique trials/people?", "needed": "Original reports, copies/bibliographic records, participant overlap and cohort independence for the six excluded families", "role": "Required", "role_reason": "Needed to avoid counting abstracts/copies/reviews of the same trial as independent replications or merging them based on shared authors alone.", "application_exception": "Whether S01 and S02 are the same cohort is unverified. Shared authors are not evidence of identity or independence.", "criterion": "Distinguish retained F01–F06 from the 11 materials, and do not newly assign unique eligible replications or pooled n.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a local application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; local application / H07: M04 §4.6.1–4.6.2; adaptations for harm materials are locally designed. Reason for application in this case: Needed to avoid counting abstracts/copies/reviews of the same trial as independent replications or merging them based on shared authors alone. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare original recruitment/participants, trial timing, authors/registration and report links to record family relationships and unverified overlap." }, { "item_id": "N29", "question_type": "Role of the review", "question": "Is the S07 review a new performance trial of the ingredient alone?", "needed": "S07 review links to original trials/formulations and report citations, and the verification scope of the relevant sections", "role": "Supplementary", "role_reason": "Needed to avoid displaying the review's B1 shorthand as direct replication that erases differences in original formulations/combinations and endpoints.", "application_exception": "The review is material for discovery/context; its original study_id null is not assigned a new clinical family identity.", "criterion": "Link citations in the review to the original derivative/combination reports, without counting them as additional trials/denominators.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a local application / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; local application. Reason for application in this case: Needed to avoid displaying the review's B1 shorthand as direct replication that erases differences in original formulations/combinations and endpoints. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the review's citations with the actual formulations, populations and endpoints in the original materials to record citation relationships." }, { "item_id": "N30", "question_type": "Registry shell", "question": "Do the S11 link and the date stated in the article prove prospective registration?", "needed": "NCT05586295 complete official record, first submission/registration, study start, version history and planned endpoints/SAP", "role": "Required", "role_reason": "Needed to avoid promoting a registration number or shell into verification of prospective registration, endpoint hierarchy or actual planned content.", "application_exception": "Preserve S05's 09/12/2022 as the original string without arbitrarily interpreting the date format. S11 links to the plan for the same F05 and is not a new trial.", "criterion": "Separate the historical 11-line shell from unverified first registration/study start and prospective registration/hierarchy.", "basis": "C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a local application / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / E06: M08 Table 8.2.a, M04 §4.6.3; local application. Reason for application in this case: Needed to avoid promoting a registration number or shell into verification of prospective registration, endpoint hierarchy or actual planned content. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the complete official change history with initial recruitment/submission and endpoint/SAP versions to examine the relationship between plans and reporting." }, { "item_id": "N31", "question_type": "Planning and selective reporting", "question": "Have the planned endpoints and reports of each related family been cross-checked?", "needed": "Original registration, protocol, SAP, endpoint hierarchy/time points and reasons for changes for eligible/related families", "role": "Required", "role_reason": "Needed to avoid turning unacquired plans into confirmed non-registration or selective reporting.", "application_exception": "Limitations of the plan audit for related families are not a new bias grade for an eligible single-ingredient product. Do not arbitrarily assign an endpoint hierarchy.", "criterion": "Preserve the unverified original plans and the scope within which selective reporting cannot be cross-checked.", "basis": "E06: M08 Table 8.2.a, M04 §4.6.3; local application / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design. Reason for application in this case: Needed to avoid turning unacquired plans into confirmed non-registration or selective reporting. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare plan versions with actual results' endpoints, time points, analyses and reasons for changes." }, { "item_id": "N32", "question_type": "Funding, products and conflicts of interest", "question": "How are company support and independence distinguished?", "needed": "Family-specific funding, product/placebo supply, analysis/author roles, employment/conflicts of interest and independence", "role": "Required", "role_reason": "Needed to avoid omitting supply/support records or establishing independence solely from declarations/affiliations.", "application_exception": "Company support alone does not lead to automatic exclusion. The absence of a printed company affiliation is not filled in as absence of employment or verified independence.", "criterion": "Preserve S05's company+public funding, product/blinding assistance and conflict-of-interest declaration together with unverified information for other families.", "basis": "C10: Chamgap's own independence/attribution criteria. The official method sections used in this pilot do not validate every detail of these items / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; local application. Reason for application in this case: Needed to avoid omitting supply/support records or establishing independence solely from declarations/affiliations. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare funding/supply, analysis/author roles and conflict-of-interest statements to record verified pathways of influence and gaps." }, { "item_id": "N33", "question_type": "Scope of corrections and retractions", "question": "What is the scope of the historical record that no notice was found?", "needed": "Family-specific correction/retraction check logs, publisher/PMC notices, DOI and cutoff date/version", "role": "Required", "role_reason": "Needed to avoid turning the failure to find a notice in limited historical checks into certification that no notices currently exist.", "application_exception": "Distinguish the historical partial checks of S01/S02/S04/S05 from the unverified scope of S03/S06. There are no publisher/DOI lookups in this review.", "criterion": "Display the limits of none_located_in_checked_sources together with the absence of an external access attempt in the current review.", "basis": "C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design. Reason for application in this case: Needed to avoid turning the failure to find a notice in limited historical checks into certification that no notices currently exist. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "In an authorized update, compare actual sources checked, dates/versions and notices' effects on the respective reports/results." }, { "item_id": "N34", "question_type": "Eligible harm denominators", "question": "Were harms and discontinuations collected for the same single-ingredient product and population?", "needed": "Eligible exposed people/people with events, event counts, duration, AE/SAE definitions/collection, dropout/discontinuation and comparator groups", "role": "Supplementary; required for a safety question", "role_reason": "Needed to avoid turning efficacy-data gaps or general safety descriptions into 0 events/incidence for the same exposure.", "application_exception": "Do not delete indirect efficacy reports because harms are unverified. Distinguish event counts, people and overlap across periods.", "criterion": "Record unverified eligible harm denominators and the lack of AE/SAE/discontinuation information in related families.", "basis": "E10: M19 §19.1.2–19.2.4; local application / H01: M19 §19.1.2–19.2.4; detailed distinctions are locally designed / H02: Design-specific harm questions in M19 §19.2; details of temporal relationships are locally designed / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; local application / H04: M19 §19.1.2–19.2.4; local application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; local application. Reason for application in this case: Needed to avoid turning efficacy-data gaps or general safety descriptions into 0 events/incidence for the same exposure. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare event collection methods, duration and denominators/reasons for discontinuation for the same population/exposure to verify the scope for interpreting frequency." }, { "item_id": "N35", "question_type": "S05 harm description", "question": "Does S05's statement of no adverse effects mean 0 events per group?", "needed": "Combination-product AE/SAE/discontinuation definitions, collection, people/event counts by group/period, exposure and tests", "role": "Supplementary", "role_reason": "Needed to avoid turning a general statement of no adverse effects or routine test results into a complete event count or safety certification.", "application_exception": "Observations of a combination in non-athletes are not incidence for an eligible single-ingredient product. Normal blood tests do not mean absence of all harms.", "criterion": "Preserve the general statement in Discussion/Table 3 together with not_reported_as_arm_period_counts.", "basis": "E10: M19 §19.1.2–19.2.4; local application / H01: M19 §19.1.2–19.2.4; detailed distinctions are locally designed / H04: M19 §19.1.2–19.2.4; local application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; local application / H09: Chamgap's own interpretive boundaries. Informed by M19 principles; not execution of an official causality tool. Reason for application in this case: Needed to avoid turning a general statement of no adverse effects or routine test results into a complete event count or safety certification. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare original collection methods, period-specific events/discontinuations and test tables to distinguish actual counts from the scope of descriptions." }, { "item_id": "N36", "question_type": "Official product safety", "question": "Is S09's oral hydrochloride product document a safety result from an athlete trial?", "needed": "Thiamine HCl 100 mg product SmPC version/jurisdiction, applicable precautions/adverse reactions, populations/excipients", "role": "Supplementary", "role_reason": "Needed to avoid extending an official product's list of harms to incidence in a specific trial or personal safety for all salts/products.", "application_exception": "Injection-related reactions are not transferred to oral incidence. Precautions concerning children/pregnancy and excipients are not turned into universal contraindications for all thiamine.", "criterion": "Limit the specific UK 100 mg oral product and its 2025-02-18 revision/PL43461/0038 record to their respective context.", "basis": "C05: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptations are locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / E10: M19 §19.1.2–19.2.4; local application / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are locally designed / H09: Chamgap's own interpretive boundaries. Informed by M19 principles; not execution of an official causality tool. Reason for application in this case: Needed to avoid extending an official product's list of harms to incidence in a specific trial or personal safety for all salts/products. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the applicable populations, excipients, harms and conditions of use of the same product/version, and record differences from the trial exposure." }, { "item_id": "N37", "question_type": "NIH safety background", "question": "Does the absence of an established upper limit mean unlimited high-dose safety?", "needed": "Version/scope of NIH official safety/interaction and at-risk-population descriptions, and evidence for the same exposure", "role": "Supplementary", "role_reason": "Needed to avoid turning the absence of an established UL or nutritional explanations into unlimited high-dose safety or personal dosing instructions.", "application_exception": "Efficacy descriptions for other diseases are not reassessed in this performance question. Official guidance does not substitute for 0 events per group in an eligible trial.", "criterion": "Separate the historical NIH risk/interaction descriptions and limitations of the absence of an established UL from current external reading.", "basis": "C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / E10: M19 §19.1.2–19.2.4; local application / H08: M19 §19.1.2–19.2.4; local application / H09: Chamgap's own interpretive boundaries. Informed by M19 principles; not execution of an official causality tool. Reason for application in this case: Needed to avoid turning the absence of an established UL or nutritional explanations into unlimited high-dose safety or personal dosing instructions. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the scope of risks/interactions in the official version with population/exposure matching, and define necessary harm questions separately." }, { "item_id": "N38", "question_type": "NICE limited access", "question": "Within what scope was the official refeeding excerpt used?", "needed": "The official original text/version of CG32 recommendation 1.4, high-risk refeeding population/professional context and actual access level", "role": "Supplementary", "role_reason": "Needed to avoid promoting an official search excerpt into full-text reading or direct verification of athlete dosing or deficiency treatment regimens.", "application_exception": "The two historical direct-URL failures are historical records. They do not constitute Inaccessible status in this review, and no dosing regimen is extracted/recommended.", "criterion": "Retain official_search_excerpt_only and the boundary of high-risk refeeding requiring skilled professionals.", "basis": "C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are locally designed / C04: M03 §3.2.1; detailed population criteria are locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / H08: M19 §19.1.2–19.2.4; local application / H09: Chamgap's own interpretive boundaries. Informed by M19 principles; not execution of an official causality tool. Reason for application in this case: Needed to avoid promoting an official search excerpt into full-text reading or direct verification of athlete dosing or deficiency treatment regimens. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the relevant section, population and professional requirements of the official recommendation with the actual access scope." }, { "item_id": "N39", "question_type": "Extensions and personal application", "question": "Do short-term related materials answer questions about optimal dose, long-term safety and other populations?", "needed": "Evidence for direct dose comparisons, long-term/post-discontinuation follow-up, special populations/deficiency, interactions and applicability questions", "role": "Supplementary; required for extended claims", "role_reason": "Needed to avoid establishing optimal supplementation dose, persistence of effects, personal safety or separate regulatory compliance from indirect short-term results.", "application_exception": "Do not impose every long-term/rare-event study as a requirement for the narrow TT question. Anti-doping/product regulatory judgments are separate from performance effects, and current regulations are not checked in this review.", "criterion": "Separate the selected TT from deficiency treatment, general safety/dose, long-term/personal application and other performance questions.", "basis": "E08: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are locally designed / E09: M03 §3.2.4; locally defined boundaries for extensions / H08: M19 §19.1.2–19.2.4; local application / H09: Chamgap's own interpretive boundaries. Informed by M19 principles; not execution of an official causality tool. Reason for application in this case: Needed to avoid establishing optimal supplementation dose, persistence of effects, personal safety or separate regulatory compliance from indirect short-term results. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Fix the population, exposure and duration of a separate extended question, and review suitable direct-comparison/long-term observational designs and applicability limitations." }, { "item_id": "N40", "question_type": "Historical verdict and calculations", "question": "Were the original ?/null and historical calculation failures/drafts used as a new status?", "needed": "Original axes/verdict, score, stage, calculation/verification limitations and draft revision history", "role": "Required", "role_reason": "Needed to avoid reusing the original score/draft or document quality as the new table's proportion of criteria met or efficacy/safety judgment.", "application_exception": "The stage-zero calculation's null-handling error and initial B suggestion are historical records; no new calculation or grade change is made. Self-review assigning document quality A is not independent clinical certification.", "criterion": "Preserve ?/score null, Caution, unscored downstream axes and null direct results unchanged.", "basis": "C01: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are locally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design. Reason for application in this case: Needed to avoid reusing the original score/draft or document quality as the new table's proportion of criteria met or efficacy/safety judgment. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Compare the original verdict and calculation/draft/final history to distinguish the roles of criterion status and clinical grade." }, { "item_id": "N41", "question_type": "Identity and package", "question": "Are the previous publication/package and creation of this new table distinguished as events?", "needed": "Current ID, canonical URL, duplicate proposal, package SHA and actual event materials for previous publication/deployment", "role": "Supplementary", "role_reason": "Needed to avoid inheriting previous site publication or a package hash as publication of the new table or verification of an original-paper binary.", "application_exception": "A duplicate candidate is not a confirmed permanent identity, and the original package SHA does not substitute for individual external-paper hashes. The old ZIP was not read in this review.", "criterion": "Preserve the current 3119/canonical record, candidate_not_permanent identity gaps and historical publication, and indicate that the new table has not been deployed.", "basis": "C01: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are locally designed / C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is a local application / C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design. Reason for application in this case: Needed to avoid inheriting previous site publication or a package hash as publication of the new table or verification of an original-paper binary. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Link the actual receipts for identity/assignment, package and publication events separately to cross-check timing and file scope." }, { "item_id": "N42", "question_type": "Cutoff date and updates", "question": "Have the evidence cutoff date and this conversion review date been distinguished?", "needed": "2026-09-16 original search strategies/results, access/registration/correction logs and the current conversion review scope", "role": "Required", "role_reason": "Needed to avoid retroactively treating historical search/access as a current exhaustive search or proof of absence of studies.", "application_exception": "The separate search/web_queries.json, native_search_log and access_log were not read in this review. Reference paths alone are not grounds for claiming that the actual logs were read.", "criterion": "Separate the original evidence cutoff date 2026-09-16, this review date 2026-10-05 and the actual scope of stored-summary reading.", "basis": "C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is locally designed / E06: M08 Table 8.2.a, M04 §4.6.3; local application. Reason for application in this case: Needed to avoid retroactively treating historical search/access as a current exhaustive search or proof of absence of studies. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "In an authorized subsequent update, cross-check search sources, strategies, dates, results/access and versions, and record change events." }, { "item_id": "N43", "question_type": "Current summary reading", "question": "Are actual stored-summary reading and historical external full-text access separated?", "needed": "Original source bytes, exact pointers/literals, current/historical reading by material type and actual method copies/SHA", "role": "Required", "role_reason": "Needed to avoid labeling historical abstracts, full-text copies, visual checking of some PDF pages and search excerpts/failures as full-text reading in this review.", "application_exception": "Distinguish the relevant sections of S04's original-paper reproduction from search snippets of related papers. full_text_stored=false/hash null is separate from historical HTML access records. Method copies do not mean new full-text reading.", "criterion": "Link only the actual current reading of the stored source summary, and leave all external material types as access not attempted, not acquired and not read in the current review.", "basis": "C03: Data collection/selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are locally designed / C09: M04 §4.5, §4.6.3; limits of the current material conversion follow the user-defined scope and local design. Reason for application in this case: Needed to avoid labeling historical abstracts, full-text copies, visual checking of some PDF pages and search excerpts/failures as full-text reading in this review. This is not new reading of complete method texts, execution of official RoB 2/GRADE/causality tools, or certification of minimum clinical criteria.", "condition_origin": "Individually authored criteria developed after reading the currently retained 3119 content and the actual family definitions. This is a known development case, not a blinded exercise or clinical preregistration.", "proposed_research": "Cross-check input bytes, original locations, actual actions by material type and method copies to verify the scope of reading labels." } ] }