# Low-dose penicillin × Reduced first recurrence during 12 months of treatment

Verdict 2973 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-14

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Adults with at least two leg-cellulitis episodes in the previous three years. Original PATCH I: 28 hospitals, 274 participants, 136/138. Detailed eligibility/baseline risk, time-specific observation/risk denominators and withdrawal/missingness remain unverified. PATCH I conditions are not automatically applied to the separate 123-person PATCH II cohort.
- Ingredient, formulation and route: Only original PATCH I study exposure is preserved: penicillin V 250 mg twice daily for 12 months. Actual adherence/discontinuation and product/formulation remain unverified; no intake/prevention/cellulitis-management or other-drug/dose/route instructions.
- Dose: Separate 12 months during treatment from off-treatment follow-up afterwards. Actual intake/duration, discontinuation/re-exposure and post-treatment windows remain unverified; no new dose/frequency/duration conversion.
- Comparator: Multicentre double-blind randomized placebo comparison. Central-pharmacy dispensing, ITT and pre-recruitment registration/matching-endpoint descriptions are preserved history, not current original-text/procedural verification. Actual placebo/contact, concurrent treatment and masking/allocation details remain unread/unverified.
- Measured outcome: Time to first clinician-confirmed recurrence; during treatment 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86)/P=.01, original absolute difference −15 percentage points and NNT 5 (4–9) are preserved as separate original estimands. People/first events/all repeated events/time are not combined; no new arithmetic/effects/CI. Post-treatment 27% in both arms is a separate-period result.
- Duration: Distinguish original PATCH I first recurrence during 12 months from lost protection after stopping. PATCH II HR 0.53 (0.26–1.07)/P=.08, 123 participants, concerns a separate cohort in the same network; exact exposure/duration/eligibility remain unverified.
- Questions outside this scope: Calculating new effects/CI, proportions/events, observation time or repeated totals from 30/136, 51/138 or 22%/37%; Recalculating/correcting original absolute difference −15 percentage points, NNT 5 (4–9) or HR 0.55, or transferring them to other periods/populations; Turning post-treatment 27% in both arms into new proof of during-treatment effects, permanent protection or exactly zero effect/equivalence; Adding/mixing first-recurrence time, recurrent people within a period and all repeated events/people/time; Applying PATCH I eligibility, 12-month exposure, registration/denominators/plans to PATCH II’s 123 participants/HR 0.53/CI/P=.08; Turning original PATCH I/II relationships into independent replication, new pooled effects or clinical-participant/trial totals; Repurposing adverse-event reporters 37/48/P=.50 as total related events, no harm, resistance measurements or equivalent safety; Inheriting original parent values/axes and historical cross-checking/registration/allocation/masking/analysis descriptions as subclaim scores or current clinical-content review/full-text reading; New arithmetic, invented quantities, effects/CI, grades/independence certification or antibiotic-use/prevention/cellulitis-management/treatment-replacement instructions

## Checklist items

### N01 · Selected first recurrence during treatment and original grade

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Selected subclaim: reduced first recurrence during 12 months, grade B, with the original 22% versus 37%/NNT 5 note. Subclaim score/status/axes are absent; parent B with 76 points does not fill the subclaim score.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence. Existing content review remains incomplete.
- Reason for missing information: Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence.
- Required materials and conditions: Original wording/grade/note versus parent values and post-treatment results
- Materials to obtain first: Original selected-subclaim/parent records and user correction comments
- Further research: Proposed follow-up comparative research specifying first-recurrence endpoints by period; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original wording/grade/note versus parent values and post-treatment results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original wording/grade/note versus parent values and post-treatment results to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N02 · Recurrence risk, eligibility and population

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original PATCH I population: adults with at least two leg-cellulitis episodes in the previous three years. Do not extend to prevention after a first episode or other sites/populations.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified. Existing content review remains incomplete.
- Reason for missing information: Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified.
- Required materials and conditions: Recent recurrence, age/eligibility, baseline risk and applicability
- Materials to obtain first: Eligibility/recruitment and baseline risk/characteristic tables
- Further research: Proposed follow-up research specifying recurrence risk and population scope; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Recent recurrence, age/eligibility, baseline risk and applicability should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Recent recurrence, age/eligibility, baseline risk and applicability to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
- Related sources: S01

### N03 · Penicillin V study exposure

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original study exposure was penicillin V 250 mg twice daily for 12 months. Preserve study exposure only; do not convert it to intake/prevention/cellulitis-management instructions.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified. Existing content review remains incomplete.
- Reason for missing information: Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified.
- Required materials and conditions: Original antibiotic, dose/frequency/duration and formulation identity
- Materials to obtain first: Study-drug ingredients/formulation, manufacture and exposure data
- Further research: Proposed follow-up research separating drug/duration from applicability; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original antibiotic, dose/frequency/duration and formulation identity should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original antibiotic, dose/frequency/duration and formulation identity to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
- Related sources: S01

### N04 · Placebo and comparison specifications

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: S01 was a multicentre double-blind randomized placebo-controlled trial. The placebo name does not verify matching of all composition/contact/concurrent management.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified. Existing content review remains incomplete.
- Reason for missing information: Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified.
- Required materials and conditions: Actual placebo composition/sensory features, contact and concurrent treatment matching
- Materials to obtain first: Placebo/contact and concurrent-exposure/masking materials
- Further research: Proposed follow-up trial specifying actual comparison conditions; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Actual placebo composition/sensory features, contact and concurrent treatment matching should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Actual placebo composition/sensory features, contact and concurrent treatment matching to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: S01

### N05 · Central pharmacy and allocation concealment

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records central-pharmacy dispensing as allocation-concealment evidence. This is not current verification of original text/allocation records or certification of the whole randomization process.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.
- Reason for missing information: Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread.
- Required materials and conditions: Original allocation/drug-supply descriptions versus actual original-text verification
- Materials to obtain first: Original allocation/drug supply, baseline and protocol materials
- Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original allocation/drug-supply descriptions versus actual original-text verification should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original allocation/drug-supply descriptions versus actual original-text verification to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed
- Related sources: S01

### N06 · Double masking and assessors

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original double-blind design and clinician-confirmed recurrence are preserved. Maintained masking of every role or exclusion of expectation effects are not treated as newly verified.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread. Existing content review remains incomplete.
- Reason for missing information: Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread.
- Required materials and conditions: Actual masking/maintenance of participants, clinicians and analysts
- Materials to obtain first: Original masking roles and adjudication/assessment materials
- Further research: Proposed follow-up research specifying endpoint adjudication and masking; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Actual masking/maintenance of participants, clinicians and analysts should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Actual masking/maintenance of participants, clinicians and analysts to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP
- Related sources: S01

### N07 · Clinician-confirmed recurrence definition

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original recurrence was clinician-confirmed, not based only on participant reports. It is not treated as the same endpoint as suspected self-reported symptoms, other infections/sites or all repeated events.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified. Existing content review remains incomplete.
- Reason for missing information: Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified.
- Required materials and conditions: Reporting, diagnostic confirmation, first/all recurrences and site definitions
- Materials to obtain first: Recurrence definitions, clinician confirmation and event adjudication data
- Further research: Proposed research specifying first clinical recurrence definitions/adjudication; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Reporting, diagnostic confirmation, first/all recurrences and site definitions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Reporting, diagnostic confirmation, first/all recurrences and site definitions to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary
- Related sources: S01

### N08 · Time to first recurrence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The primary endpoint was time to first clinician-confirmed recurrence. HR, proportions of people within a period, all recurrences and total observation time are not combined as the same estimand.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified. Existing content review remains incomplete.
- Reason for missing information: Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified.
- Required materials and conditions: Prespecified primary time endpoint versus proportions/total events
- Materials to obtain first: Time/censoring, first-event and model/at-risk population data
- Further research: Proposed follow-up research distinguishing time endpoints from period proportions/repeated events; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Prespecified primary time endpoint versus proportions/total events should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Prespecified primary time endpoint versus proportions/total events to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application
- Related sources: S01

### N09 · During treatment: 30/136 and 51/138

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: First recurrence during treatment was 30/136 (22%) versus 51/138 (37%). Distinguish recurrent participants, all repeated events, observation time and randomized populations; no new proportions/event totals are calculated.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified. Existing content review remains incomplete.
- Reason for missing information: Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified.
- Required materials and conditions: Original first-recurrence people/denominators and 22%/37%
- Materials to obtain first: Original recurrence/at-risk populations and observations/events
- Further research: Proposed research reporting people/event/time denominators separately; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original first-recurrence people/denominators and 22%/37% should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original first-recurrence people/denominators and 22%/37% to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: S01

### N10 · HR 0.55·CI·P

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original HR 0.55 (95% CI 0.35–0.86), P=.01 is preserved. No new RR/OR, HR, CI or individual risks are calculated from 22%/37%.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread. Existing content review remains incomplete.
- Reason for missing information: Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread.
- Required materials and conditions: Original first-recurrence time effect/CI versus proportions
- Materials to obtain first: Time models, adjustment/CI and assumption/sensitivity data
- Further research: Proposed follow-up research reporting time effects and uncertainty; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original first-recurrence time effect/CI versus proportions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original first-recurrence time effect/CI versus proportions to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design
- Related sources: S01

### N11 · Original absolute difference and NNT

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original absolute difference −15 percentage points and NNT 5 (4–9) are preserved unchanged. They are not recalculated/corrected through new arithmetic or transferred to other periods/populations/drugs.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original estimation/period/model, CI methods and risk-reference details for each number remain unread. Existing content review remains incomplete.
- Reason for missing information: Original estimation/period/model, CI methods and risk-reference details for each number remain unread.
- Required materials and conditions: Original absolute difference/NNT and period/analysis/estimation specifications
- Materials to obtain first: Original absolute difference/NNT and period/method/CI materials
- Further research: Proposed follow-up research separating absolute/time effects and calculation specifications; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original absolute difference/NNT and period/analysis/estimation specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original absolute difference/NNT and period/analysis/estimation specifications to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M15 §15.3.1–15.3.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed
- Related sources: S01

### N12 · 27% after stopping and persistence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original off-treatment follow-up had 27% recurrence in both arms and no persistent protection. This is not new proof of the during-treatment HR/proportions, permanent prevention or exactly zero effect/equivalence.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified. Existing content review remains incomplete.
- Reason for missing information: Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified.
- Required materials and conditions: During-treatment versus post-treatment results, denominators/estimation
- Materials to obtain first: Post-treatment results, follow-up/denominators and effects/CI
- Further research: Proposed follow-up research distinguishing persistence during/after treatment; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for During-treatment versus post-treatment results, denominators/estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing During-treatment versus post-treatment results, denominators/estimation to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed
- Related sources: S01

### N13 · 12 months, exposure, adherence/discontinuation

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original 12-month study exposure is preserved. It does not establish full-period complete intake/actual exposure in everyone or continued protection afterwards.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified. Existing content review remains incomplete.
- Reason for missing information: Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified.
- Required materials and conditions: Planned treatment duration versus actual exposure/stopping/changes
- Materials to obtain first: Exposure/adherence, discontinuation/changes and period records
- Further research: Proposed research distinguishing planned/actual exposure and period-specific effects; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Planned treatment duration versus actual exposure/stopping/changes should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Planned treatment duration versus actual exposure/stopping/changes to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed
- Related sources: S01

### N14 · 274 participants, 28 hospitals and 136/138

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: PATCH I assigned 274 participants at 28 hospitals, 136/138. Hospitals, arms, time, events and citations are not added as new independent trials/participants.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified. Existing content review remains incomplete.
- Reason for missing information: Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified.
- Required materials and conditions: Recruitment/randomization denominators versus endpoint observation/at-risk populations
- Materials to obtain first: Flow, hospital/arm-specific and endpoint/time denominators
- Further research: Proposed research distinguishing recruitment/observation/risk denominators; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Recruitment/randomization denominators versus endpoint observation/at-risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Recruitment/randomization denominators versus endpoint observation/at-risk populations to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application
- Related sources: S01

### N15 · ITT principle and actual analysis populations

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records historical wording that all analyses followed ITT. This does not newly verify complete observation or detailed denominators/models for every result.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread. Existing content review remains incomplete.
- Reason for missing information: Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread.
- Required materials and conditions: Original ITT versus inclusion/exclusion, estimation populations and censoring specifications
- Materials to obtain first: Original ITT, censoring/inclusion and sensitivity materials
- Further research: Proposed research separately disclosing assignment/exposure/observation analyses; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original ITT versus inclusion/exclusion, estimation populations and censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original ITT versus inclusion/exclusion, estimation populations and censoring specifications to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed
- Related sources: S01

### N16 · Missingness, withdrawals and observation time

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: Original randomized denominators and ITT descriptions are preserved. No assumption of zero missingness/withdrawal or no effects from infection reporting/confirmation/follow-up differences is filled in.
- Why unverified: Required current information remains unverified in the preserved summary. Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified. Existing content review remains incomplete.
- Reason for missing information: Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified.
- Required materials and conditions: Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation
- Materials to obtain first: Flow, observation time/censoring and missingness/sensitivity data
- Further research: Proposed research reporting follow-up and its effects on first-event estimation; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application
- Related sources: S01

### N17 · Two registrations and prespecified plans

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original evidence registration identifier: ISRCTN34716921 · EudraCT 2006-000381-36. Pre-recruitment registration and matching first-recurrence endpoint descriptions are preserved; full registration/plans remain unread.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread. Existing content review remains incomplete.
- Reason for missing information: Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread.
- Required materials and conditions: ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions
- Materials to obtain first: Both registration histories, protocol and SAP
- Further research: Proposed research linking and disclosing prespecified plans and actual period-specific analyses; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
- Related sources: S01

### N18 · Primary/secondary outcomes, periods and multiple tests

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original primary endpoint was time to first recurrence. Post-treatment, all-recurrence, safety and other analyses are not upgraded to new primary endpoints or independent confirmation.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified. Existing content review remains incomplete.
- Reason for missing information: All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified.
- Required materials and conditions: First-recurrence primary endpoint versus other events/periods/subgroup hierarchy
- Materials to obtain first: SAP, all results and endpoint/period hierarchies
- Further research: Proposed research distinguishing primary from period-specific/secondary results; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for First-recurrence primary endpoint versus other events/periods/subgroup hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing First-recurrence primary endpoint versus other events/periods/subgroup hierarchy to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application
- Related sources: S01

### N19 · Concurrent treatment and recurrence-risk management

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: This was a placebo-controlled trial in adults at risk of recurrent leg cellulitis. The original summary is not extended to confirm identical concurrent treatment/management or no influence on effects.
- Why unverified: Required current information remains unverified in the preserved summary. Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified. Existing content review remains incomplete.
- Reason for missing information: Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified.
- Required materials and conditions: Concurrent medications/conditions/lifestyle management and contact by arm
- Materials to obtain first: Concurrent exposure/management, contact and analysis materials
- Further research: Proposed follow-up research distinguishing concurrent management from study-drug effects; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Concurrent medications/conditions/lifestyle management and contact by arm should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Concurrent medications/conditions/lifestyle management and contact by arm to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design
- Related sources: S01

### N20 · PATCH II companion report and directness

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original S02 PATCH II: 123 participants, HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. The same 12-month/recurrence-risk/exposure specifications are not automatically filled in.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified. Existing content review remains incomplete.
- Reason for missing information: PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified.
- Required materials and conditions: Separate-cohort results versus PATCH I specifications
- Materials to obtain first: PATCH II original text/plans and correspondence between both trials
- Further research: Proposed follow-up research specifying separate cohorts/specifications; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate-cohort results versus PATCH I specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate-cohort results versus PATCH I specifications to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed
- Related sources: S02

### N21 · Two estimates, nonsignificance and conflict scope

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original interpretation that PATCH II’s CI includes PATCH I’s 0.55 and is not statistically conflicting is preserved. No new pooled effects, CI, significance or equivalence/conflict verdicts are calculated.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified. Existing content review remains incomplete.
- Reason for missing information: Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified.
- Required materials and conditions: PATCH II CI and the original verdict’s relationship interpretation
- Materials to obtain first: Both results/specifications and comparison/pooling methods
- Further research: Proposed research distinguishing matching specifications from result relationships; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for PATCH II CI and the original verdict’s relationship interpretation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing PATCH II CI and the original verdict’s relationship interpretation to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application
- Related sources: S01, S02

### N22 · Reports, cohorts, network and independence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: PATCH I/II were separate cohorts in the same network, so the original verdict did not count independent replication. 274/123, hospitals, arms, time points, citations/related sheets are not added as new participant/trial totals.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. No new unique-clinical-trial/participant or independent-replication totals are established. Existing content review remains incomplete.
- Reason for missing information: No new unique-clinical-trial/participant or independent-replication totals are established.
- Required materials and conditions: PATCH I/II separate cohorts versus the same network
- Materials to obtain first: Cohort/network and report/registration relationships, plus separate research materials
- Further research: Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.
- Conditions for verification: Relevant originals and analysis scope for PATCH I/II separate cohorts versus the same network should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing PATCH I/II separate cohorts versus the same network to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: S01, S02

### N23 · Action Medical Research funding

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original PATCH I funding was nonprofit support from Action Medical Research. This does not become new certification of no support/COI or independence.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Funder roles, contracts, other support and original data/publication authority remain unread. Existing content review remains incomplete.
- Reason for missing information: Funder roles, contracts, other support and original data/publication authority remain unread.
- Required materials and conditions: Nonprofit funding versus support roles/other relationships
- Materials to obtain first: Original funding, support/authority and COI materials
- Further research: Proposed follow-up research disclosing support roles; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Nonprofit funding versus support roles/other relationships should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Nonprofit funding versus support roles/other relationships to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N24 · Nottingham sponsorship and pharmaceutical support

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records University of Nottingham as sponsor and pharmaceutical cash/product/analysis support as not identified. Unverified does not mean actually absent or no author relationships.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread. Existing content review remains incomplete.
- Reason for missing information: Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread.
- Required materials and conditions: Research sponsor and verification of cash/product/analysis support
- Materials to obtain first: Sponsor, cash/product/analysis and author/writing support disclosures
- Further research: Proposed research separately disclosing research roles and item-specific support; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Research sponsor and verification of cash/product/analysis support should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Research sponsor and verification of cash/product/analysis support to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design
- Related sources: S01

### N25 · Adverse-event reporters and P

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original adverse-event reporters numbered 37 versus 48, P=.50. Person counts are not converted to total events, related reactions, no harm or equivalent safety.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified. Existing content review remains incomplete.
- Reason for missing information: Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified.
- Required materials and conditions: People versus event counts/denominators and nonsignificance versus safety
- Materials to obtain first: Adverse-event tables, denominators/collection and causality/severity data
- Further research: Proposed harm research distinguishing people/events and uncertainty; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for People versus event counts/denominators and nonsignificance versus safety should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing People versus event counts/denominators and nonsignificance versus safety to connect materials needed for the selected question with available materials.
- Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application
- Related sources: S01

### N26 · Allergy, gastrointestinal and resistance gaps

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original parent caution and allergy/gastrointestinal/antimicrobial-resistance burdens are preserved. Warnings are not made into actual event rates/resistance measurements or intake/prevention instructions.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified. Existing content review remains incomplete.
- Reason for missing information: Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified.
- Required materials and conditions: Parent caution wording versus actual harm/resistance measurement
- Materials to obtain first: Harm-specific collection and resistance/long-term follow-up data
- Further research: Proposed follow-up research specifying harm/resistance collection scope; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Parent caution wording versus actual harm/resistance measurement should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Parent caution wording versus actual harm/resistance measurement to connect materials needed for the selected question with available materials.
- Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M19 §19.1.2–19.2.4; CHAMGAP adaptation
- Related sources: S01

### N27 · Other drugs/populations and persistent application

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and permanent protection. Preserve research results only; no management/treatment-replacement instructions.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified. Existing content review remains incomplete.
- Reason for missing information: Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified.
- Required materials and conditions: Original recurrence risk, drug/route/duration versus long-term generalization
- Materials to obtain first: Direct population/drug/duration-specific trials and follow-up data
- Further research: Proposed follow-up research distinguishing specifications/period from persistent protection; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original recurrence risk, drug/route/duration versus long-term generalization should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original recurrence risk, drug/route/duration versus long-term generalization to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed
- Related sources: S01

### N28 · Parent/subclaim, bilingual text and history

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Parent B with 76 points, B/H/R1/I2/E+/B0, unrecorded precision, true large-hard-endpoint-RCT and two false indicators, empty grade-override reasons and subclaim B/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim scores.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification. Existing content review remains incomplete.
- Reason for missing information: Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification.
- Required materials and conditions: Separate original score/axes, evidence date, corrections and verification descriptions
- Materials to obtain first: Original corrections, versions and user correction comments
- Further research: Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate original score/axes, evidence date, corrections and verification descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate original score/axes, evidence date, corrections and verification descriptions to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed
- Related sources: S01, S02

### N29 · Actual summary reading and material links

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The entire preserved summary/citations were used for production and PATCH I/II links retained. Original papers/registration/protocol/SAP/support/COI remain unread, access unattempted and external links untested.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact denominators/duration/models and accessibility remain unverified. Existing content review remains incomplete.
- Reason for missing information: External original content, exact denominators/duration/models and accessibility remain unverified.
- Required materials and conditions: Reading preserved summaries versus external papers/two registrations/plans
- Materials to obtain first: Original paper, registration, protocol, SAP and support materials or user comments
- Further research: Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.
- Conditions for verification: Relevant originals and analysis scope for Reading preserved summaries versus external papers/two registrations/plans should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Reading preserved summaries versus external papers/two registrations/plans to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: S01, S02

## Evidence and sources

### S01

Thomas KS et al. 2013 PATCH I

[PubMed](https://pubmed.ncbi.nlm.nih.gov/23635049/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 30/136 (22%) vs 51/138 (37%); HR 0.55 (0.35–0.86), P=.01; NNT 5 (4–9). Grade B. PATCH I first recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86), P=.01, absolute difference −15 percentage points and NNT 5 (4–9). After stopping, 27% in both arms recurred and protection did not persist.  
Record level: Outcome wording in the stored summary  
Independent replication: PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

### S02

UK Dermatology Clinical Trials Network. PATCH II. Br J Dermatol. 2012. PMID: 21910701.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/21910701/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: PATCH II’s 123 participants had HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. Its interval includes PATCH I’s 0.55 estimate and was described as not statistically conflicting. It was a separate cohort in the same network and was not counted as independent replication.  
Record level: Outcome wording in the stored summary  
Independent replication: PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. |
| External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |
| Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
- Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
- Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
- Review incomplete: Existing content review remains incomplete.
- Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
- Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
- Not applicable: Not used as a substitute for an evidence gap.
- Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
- Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

## Change history

2026-10-14 · Public page/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.