This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children (NCT00824655), a non-randomized phase 3 study. The primary outcome is Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00824655 |
| Phase | Phase 3 |
| Condition | Pneumococcal Vaccines |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 234 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Healthy children previously partially immunized with Prevenar were eligible for the study. The primary immunogenicity analysis concerned an evaluable toddler population: eligible participants who received vaccine at the expected dose or doses, had blood drawn within specified timeframes, had at least one valid and determinate assay result for the proposed analysis, and had no major protocol violations. Enrollment was 234.
Intervention
The study evaluated 13-valent pneumococcal conjugate vaccine, abbreviated 13vPnC, in children who had already received Prevenar. The registry describes groups with vaccine schedules labeled as 13vPnC/13vPnC at 5 months, 13vPnC/13vPnC at 6 months of age, 13vPnC/13vPnC at 12 months, and 13vPnC at 12 months. Detailed arm descriptions are not reported in the registry record.
Comparator
All listed groups received 13vPnC, and allocation was non-randomized. The registry record therefore does not describe a randomized control comparison. Differences between groups should not be read as like-for-like causal contrasts; the record itself cautions that the arms are not a like-for-like control comparison.
Primary question
The primary endpoint was the geometric mean concentration of serotype-specific pneumococcal IgG antibodies one month after the toddler dose, at 13 months of age. It covered seven common serotypes and six additional serotypes specific to 13vPnC. The stated aim was to assess the antibody response after vaccination, alongside the study’s safety and tolerability aims. Numerical primary endpoint estimates are not reported in the registry record.
3. Trial Design
This was a Phase 3, open-label, non-randomized, parallel-group trial. It evaluated 13-valent pneumococcal conjugate vaccine in healthy children previously partially immunized with Prevenar. The registry lists enrollment of 234 and marks the study completed. The recorded start was 2009-03, and primary completion was 2010-06.
The group labels describe schedules involving 13vPnC at 5 months, 6 months of age, or 12 months, including labels that list two 13vPnC vaccinations. The registry lists two biological interventions, both named 13vPnC. However, the detailed arm descriptions are blank, so the complete dose sequence and the intended distinctions among arms are not reported in the registry record. The record identifies no masking.
Because allocation was non-randomized, the groups should not be interpreted as randomized treatment arms. Their composition may differ for reasons that the record does not describe, and any contrast could reflect those differences as well as the vaccination schedule. The registry explicitly cautions that these arms are not a like-for-like control comparison. No separate untreated or placebo group is listed in the record.
The primary immunogenicity outcome was assessed one month after the toddler dose, at 13 months of age. Its analysis population was defined by eligibility, receipt of the expected vaccine dose or doses, blood collection within specified timeframes, an available valid and determinate assay result, and absence of major protocol violations. The study also assessed safety, tolerability, injection-site reactions, and antibody responses at other timepoints. A complete statistical analysis plan, including any prespecified contrasts between groups, is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.
Infant Series (5 Months of Age)
| Stage | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| STARTED | 118 | 0 |
| COMPLETED | 118 | 0 |
| NOT COMPLETED | 0 | 0 |
After Infant Dose (6 Months of Age)
| Stage | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| STARTED | 118 | 0 |
| COMPLETED | 118 | 0 |
| NOT COMPLETED | 0 | 0 |
Toddler Dose (12 Months of Age)
| Stage | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| STARTED | 118 | 116 |
| COMPLETED | 116 | 116 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | 13vPnC/13vPnC | 13vPnC |
|---|---|---|
| Adverse Event | 1 | 0 |
| Parent/legal guardian request | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | 13vPnC/13vPnC | 13vPnC | Total |
|---|---|---|---|---|
| Participants analysed | 118 | 116 | 234 | |
| Age Continuous | months | 5.1 (SD 0.37) | 11.9 (SD 0.52) | 8.5 (SD 3.42) |
| Sex/Gender, Customized: Female | participants | 50 | 60 | 110 |
| Sex/Gender, Customized: Male | participants | 68 | 56 | 124 |
6. Primary Endpoint
The registry lists the primary outcome as Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose, measured over 1 month after the toddler dose (13 months of age).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mcg/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the geometric mean concentration, or GMC, of pneumococcal immunoglobulin G antibodies one month after the toddler dose, at 13 months of age. Concentrations were measured in mcg/mL. The endpoint covered serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, as well as serotypes 1, 3, 5, 6A, 7F, and 19A, described as additional serotypes specific to 13vPnC.
As a general statistical concept, a geometric mean is useful for measurements that are positive and may be distributed unevenly across participants. It summarizes the central level on a multiplicative scale and can be less dominated by unusually high values than an arithmetic mean. The registry says GMCs were calculated using participants with available data for the specified blood draw. It also says corresponding two-sided 95% confidence intervals were evaluated.
Antibody concentration is an immunogenicity measure: it describes the measured antibody response, not a direct count of infections or a clinical disease outcome. The registry record does not report the numerical GMCs or their confidence intervals, so the size and precision of the observed antibody concentrations cannot be assessed from the recorded primary results. The endpoint alone also cannot establish a clinical benefit.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint is a serotype-specific antibody concentration measured one month after the toddler dose. The registry describes the measure and the population used for its analysis, but numerical GMC estimates and confidence limits are not reported in the registry record. Consequently, the primary result’s magnitude and statistical precision cannot be described from this record. The endpoint definition is not itself a numerical finding.
The record lists 13 serotypes: seven common pneumococcal serotypes and six additional serotypes specific to 13vPnC. A separate antibody estimate for each serotype would describe the measured concentration for that serotype; it would not, by itself, establish a clinical effect. The registry also lists secondary immunogenicity outcomes involving the percentage of participants meeting an antibody threshold and GMCs at other timepoints, but their numerical results are not included in the registry record recorded.
The trial was open-label and non-randomized. Therefore, the groups do not support the same interpretation as randomized, exchangeable groups. A difference across the group labels, if considered, could be associated with the schedule or with other differences between the children; the registry does not report enough information to separate those possibilities. The record specifically warns that the arms are not a like-for-like control comparison. It is not appropriate to interpret group contrasts as clean causal estimates.
The posted safety counts are descriptive. For the groups labeled 13vPnC/13vPnC at 5 months, 13vPnC/13vPnC at 6 months of age, 13vPnC/13vPnC at 12 months, and 13vPnC at 12 months, the recorded serious adverse event counts are 1, 4, 1, and 0, respectively. The corresponding numbers at risk are 118, 118, 116, and 116. These counts alone do not establish whether events were caused by vaccination, and without a comparable randomized control group they do not support a causal safety comparison. Death counts are not reported in the registry record.
As a general statistical concept, a confidence interval describes uncertainty around an estimate under the analysis assumptions; it is not a guarantee that the true value lies within its limits. Since the numerical confidence intervals are not reported, no claim about the precision of the GMC estimates is warranted. The registry also reports no listed analyses, so inferential claims such as a tested difference or statistical significance are not available. Overall, the record supports description of the trial’s aims, endpoint, populations, and posted safety counts, but not a numerical conclusion about the primary immunogenicity result.
9. Statistical Methods Explained
What does a geometric mean concentration describe?
The primary endpoint is the geometric mean concentration of serotype-specific IgG antibodies. As a general statistical explanation, a geometric mean is calculated by taking the mean on a logarithmic scale and converting it back to the original measurement scale. This approach is often used for positive concentration data, which may vary multiplicatively and have a skewed distribution. The resulting value summarizes the typical concentration without treating every absolute increase as equally informative across the full range.
The endpoint is reported in mcg/mL. The registry specifies that GMCs were calculated using participants with available data for the specified blood draw. It lists results for seven common pneumococcal serotypes and six additional serotypes specific to 13vPnC. The numerical GMC values are not reported in the registry record, so the actual concentrations cannot be interpreted from the record.
How should the confidence interval be understood?
The registry says that corresponding two-sided 95% confidence intervals were evaluated. In general, a confidence interval conveys the uncertainty associated with an estimate under the statistical model and sampling process. A narrower interval indicates greater precision than a wider interval, but the interval does not describe the range of individual participants’ antibody concentrations. Nor does a confidence interval, on its own, determine whether a measured antibody concentration implies protection.
Although the confidence interval method and nominal level are described, the interval endpoints are not reported in the registry record. There is therefore no basis for characterizing the precision of any particular serotype estimate. The record does not state whether the GMC estimates were adjusted for other variables or whether comparisons between groups were formally tested.
Who was included in the primary analysis?
The primary analysis used an evaluable toddler immunogenicity population. The registry defines eligibility for that population by receipt of the expected dose or doses, blood collection within specified timeframes, at least one valid and determinate assay result for the proposed analysis, and no major protocol violations. This is a restricted analysis population rather than a simple description of every enrolled child.
Such criteria can make an immunogenicity analysis dependent on whether participants have usable blood samples and valid assay results. As a general point, exclusions from an evaluable population can affect how representative an estimate is of all enrolled participants. The numbers excluded, reasons for exclusion, and any comparison of included and excluded participants are not reported in the registry record. The record does not describe imputation or another method for handling unavailable antibody measurements.
What does non-randomized allocation mean for comparisons?
In a randomized study, random allocation is intended to make groups comparable on average, including for factors that may not be measured. This is a general statistical principle, not a description of this trial. Here, allocation was non-randomized, masking was absent, and the record cautions that the arms are not a like-for-like control comparison. As a result, group differences cannot automatically be attributed to schedule differences. The registry does not provide enough detail about allocation or group characteristics to assess potential confounding.
The trial is described as parallel-group, but that label does not make the groups randomized or establish that their participants were comparable. Both listed interventions are 13vPnC. The arm descriptions are blank, and the record does not provide a full account of the schedule distinctions. No prespecified method for a between-group comparison is reported.
What can be inferred from the analysis record?
The record lists eight outcome measures and zero analyses. This means the record as described contains endpoint definitions but no listed analysis results from which to assess statistical tests or estimated contrasts. The primary measure is descriptive in the available information: a GMC and its stated confidence interval approach. P-values, adjusted estimates, and a formal statistical comparison are not reported in the registry record.
As a general concept, multiple serotypes and multiple timepoints create multiple opportunities to examine results. When many outcomes are tested, the chance of at least one apparently unusual result can increase unless the analysis accounts for multiplicity. Whether any multiplicity adjustment or hierarchy was planned is not reported in the registry record, so no correction method should be assumed.
The record includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are planning illustrations based on the observed effect, not a report of the trial’s original design assumptions. Their sample-size values should be understood as hypothetical planning quantities, not observed power. The actual sample-size justification and statistical plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures, including the primary serotype-specific GMC and secondary immunogenicity measures at other timepoints. The primary outcome itself spans 13 serotypes. Examining multiple outcomes can raise multiplicity concerns: as a general statistical concept, the more hypotheses tested, the greater the chance that at least one result appears notable by chance alone. The registry record does not report a multiplicity strategy, such as an adjustment method, a prespecified hierarchy, or a rule for interpreting results across serotypes.
The record lists zero analyses. It does not provide numerical outcome estimates, confidence limits, p-values, or a description of which comparisons were performed. The intended statistical analysis plan, including any planned group contrasts or confirmatory testing strategy, is not reported in the registry record. Thus, the presence of several outcome definitions should not be mistaken for evidence that every outcome was analyzed or formally tested.
For the primary immunogenicity endpoint, the stated analysis population required an expected vaccine dose or doses, a blood draw within specified timeframes, at least one valid and determinate assay result, and no major protocol violations. The registry says GMCs used participants with available data for the specified blood draw. This indicates that availability of assay data was relevant to analysis, but the number of missing samples, the reasons for missingness, and any sensitivity analyses are not reported in the registry record.
Imputation, handling of invalid assays, and treatment of protocol deviations beyond the evaluable population definition are not described. The record also does not report whether analysis populations were defined separately for safety outcomes. These omissions limit assessment of how missing information or analysis-population selection may have affected the results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 13vPnC/13vPnC at 5 Months | 1 | 118 | 0.8% |
| 13vPnC/13vPnC at 6 Months of Age | 4 | 118 | 3.4% |
| 13vPnC/13vPnC at 12 Months | 1 | 116 | 0.9% |
| 13vPnC at 12 Months | 0 | 116 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 13vPnC/13vPnC at 5 Months | 92 of 118 |
| 13vPnC/13vPnC at 6 Months of Age | 4 of 118 |
| 13vPnC/13vPnC at 12 Months | 91 of 116 |
| 13vPnC at 12 Months | 86 of 116 |
Most frequent serious adverse event terms
| Event term | Organ system | 13vPnC/13vPnC at 5 Months | 13vPnC/13vPnC at 6 Months of Age | 13vPnC/13vPnC at 12 Months | 13vPnC at 12 Months |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | 0 of 118 | 4 of 118 | 0 of 116 | 0 of 116 |
| Diarrhoea | Gastrointestinal disorders | 1 of 118 | 0 of 118 | 1 of 116 | 0 of 116 |
| Intussusception | Gastrointestinal disorders | 0 of 118 | 1 of 118 | 0 of 116 | 0 of 116 |
| Foreign body | Injury, poisoning and procedural complications | 0 of 118 | 1 of 118 | 0 of 116 | 0 of 116 |
| Vomiting | Gastrointestinal disorders | 0 of 118 | 0 of 118 | 1 of 116 | 0 of 116 |
| Bronchitis | Infections and infestations | 0 of 118 | 0 of 118 | 1 of 116 | 0 of 116 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 118 | 0 of 118 | 1 of 116 | 0 of 116 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 13vPnC/13vPnC at 5 Months | 13vPnC/13vPnC at 6 Months of Age | 13vPnC/13vPnC at 12 Months | 13vPnC at 12 Months |
|---|---|---|---|---|---|
| Irritability | General disorders | 92 of 114 | 0 of 0 | 91 of 111 | 86 of 113 |
| Redness (Any) | Skin and subcutaneous tissue disorders | 43 of 107 | 0 of 0 | 65 of 104 | 67 of 113 |
| Tenderness (Any) | Skin and subcutaneous tissue disorders | 39 of 108 | 0 of 0 | 62 of 104 | 58 of 110 |
| Swelling (Any) | Skin and subcutaneous tissue disorders | 35 of 104 | 0 of 0 | 56 of 104 | 60 of 110 |
| Redness (Mild) | Skin and subcutaneous tissue disorders | 39 of 107 | 0 of 0 | 54 of 103 | 58 of 113 |
| Increased sleep | General disorders | 54 of 106 | 0 of 0 | 50 of 101 | 42 of 108 |
| Swelling (Mild) | Skin and subcutaneous tissue disorders | 33 of 104 | 0 of 0 | 52 of 104 | 57 of 109 |
| Decreased appetite | General disorders | 39 of 107 | 0 of 0 | 48 of 103 | 48 of 109 |
| Decreased sleep | General disorders | 44 of 112 | 0 of 0 | 38 of 105 | 35 of 106 |
| Fever ≥38°C but ≤39°C | General disorders | 27 of 103 | 0 of 0 | 31 of 99 | 34 of 105 |
Serious events with the highest arm-level rate: gastroenteritis (3.4%), diarrhoea (0.9%), vomiting (0.9%), bronchitis (0.9%), asthma (0.9%).
The safety summary records serious adverse events for four schedule-labeled groups. In the order listed in the registry, the groups were 13vPnC/13vPnC at 5 months, 13vPnC/13vPnC at 6 months of age, 13vPnC/13vPnC at 12 months, and 13vPnC at 12 months. The numbers at risk were 118, 118, 116, and 116; the serious adverse event counts were 1, 4, 1, and 0. The corresponding counts recorded for other adverse events were 92, 4, 91, and 86.
These are descriptive counts. The registry record does not establish that an event was caused by vaccination, and the groups are non-randomized rather than like-for-like controls. The counts should not be treated as causal comparisons. The death entries are not reported in the registry record, so they cannot be interpreted as zero deaths.
The registry also lists serious-event terms and percentages: Gastroenteritis, 3.4%; Diarrhoea, 0.9%; Vomiting, 0.9%; Bronchitis, 0.9%; Asthma, 0.9%; and Intussusception, 0.8%. The record does not assign these terms to a particular group in the registry record. These percentages should therefore be read as listed safety information, not as group-specific rates or evidence of causation.
12. What the Result Does, and Does Not, Mean
The trial was designed to evaluate safety, tolerability, and immunogenicity of 13vPnC in healthy children previously partially immunized with Prevenar. Its primary endpoint was an antibody concentration measure at a specified time after the toddler dose. That measure can describe the immune response in the analyzed population, but it is not a direct measure of clinical disease or protection.
The registry record gives the endpoint definition and states that GMCs and corresponding two-sided 95% confidence intervals were evaluated. It does not report the numerical estimates or confidence limits. Therefore, the registry entries do not show how high or low the measured antibody concentrations were, or how precisely they were estimated. No conclusion about the primary result’s magnitude can be drawn from the endpoint description alone.
The record also does not establish that the vaccine prevents illness, nor does it establish that it fails to do so. Clinical efficacy outcomes are not presented in the registry record. Antibody levels can be useful immunogenicity measures, but translating a concentration into a clinical outcome requires evidence beyond the concentration measure itself. No such inference should be made from this record alone.
Safety counts are likewise descriptive, not proof of causation. The non-randomized allocation and the registry’s explicit warning that the arms are not like-for-like comparisons limit interpretation of between-group differences. The record does not provide a randomized control group or enough information to adjust for possible group differences.
The result that can be stated precisely is what the registry intended to measure and how it defined the primary analysis population. Numerical primary endpoint findings, a formal inferential comparison, and causal conclusions are not reported in the registry record. The trial’s schedule labels and safety summaries provide context, but do not replace those missing outcome estimates or a suitable comparative design.
13. Why This Trial Matters Statistically
This trial illustrates why an endpoint’s definition and its numerical result are not interchangeable. The registry clearly identifies a serotype-specific antibody GMC, the measurement unit, the assessment time, and the intended analysis population. Those details explain what the study sought to estimate. Without the numerical estimates and confidence limits, however, readers cannot assess the response’s magnitude or precision.
It also highlights the importance of design when interpreting contrasts. The study was open-label and non-randomized, and the record cautions that its arms are not a like-for-like control comparison. A statistical difference between groups, if one were reported, would not by itself establish that the vaccination schedule caused the difference. Allocation and group composition matter to the interpretation of an estimate, not only its numerical size.
The endpoint is immunogenicity rather than a direct clinical outcome. Statistical interpretation must keep the measured antibody concentration separate from claims about illness or protection. In addition, several serotypes and outcomes raise the question of multiplicity, while the registry record does not state a testing hierarchy or adjustment approach.
Finally, the evaluable analysis population depends on valid assay data, appropriate blood-draw timing, expected vaccination, and absence of major protocol violations. Such criteria are relevant to the population represented by the estimate. The registry does not report how many participants met or failed those conditions or how missing data were handled. These features make the record useful for understanding the study’s structure, while also marking clear boundaries on what can be concluded statistically.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry gives limited detail about the arms. Although it lists four schedule labels and two 13vPnC biological interventions, the detailed arm descriptions are blank. The exact dosing sequences and the intended distinctions between groups are therefore not fully reported in the registry record. This makes it difficult to characterize the precise contrasts that the study was intended to examine.
Allocation was non-randomized, masking was absent, and the record warns that arms are not a like-for-like control comparison. The registry does not report participant characteristics by group or an adjustment strategy that might address group differences. Any apparent contrast would therefore require caution, and causal interpretation is not supported by the design information recorded.
The primary outcome is an immunogenicity measure, and numerical GMC estimates and confidence intervals are not reported. Although the record describes the endpoint, it does not permit assessment of the observed antibody levels or their precision. The numerical results for the listed secondary immunogenicity outcomes are also not included in the registry record recorded.
For the evaluable toddler immunogenicity population, the registry specifies criteria involving vaccination, blood-draw timing, valid assay results, and protocol violations. It does not report the number of participants meeting those criteria, the amount or reasons for missing data, or sensitivity analyses. Death counts are not reported in the registry record. The analysis plan, multiplicity approach, and original sample-size justification are also not reported. These gaps limit assessment of outcome completeness, analytical choices, and the robustness of any estimated effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children — NCT00824655.
- Registry record last updated 2011-08-10; status last verified 2011-08.
- Results first posted 2011-07-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00824655 is a completed Phase 3, open-label, non-randomized, parallel-group study of 13vPnC in healthy children previously partially immunized with Prevenar. Enrollment was 234. The recorded start was 2009-03, and primary completion was 2010-06.
The primary endpoint was serotype-specific pneumococcal IgG GMC one month after the toddler dose, at 13 months of age, with corresponding two-sided 95% confidence intervals described. The endpoint covered seven common serotypes and six additional serotypes specific to 13vPnC. Numerical primary GMC estimates and confidence limits are not reported in the registry record.
The record includes descriptive safety counts across four schedule-labeled groups and lists serious adverse event terms. Allocation was non-randomized, and the record cautions that the arms are not a like-for-like control comparison. The statistical analysis plan, multiplicity approach, and details of missing-data handling are not reported.