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 Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery (NCT03123068), a randomized phase 1, phase 2 study. The primary outcome is NFkB Signaling in Innate Immune Cells.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03123068 |
| Phase | Phase 1, Phase 2 |
| Condition | Surgical Recovery |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 74 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
Population
Participants undergoing surgery for whom the registry describes surgical recovery as the condition of interest. The primary analysis population is described as participants with available data. The record says three patients were excluded from the molecular analysis because of incorrect study-medication intake, difficulties obtaining blood draws, and a non-recognized immune disorder. Further details about eligibility criteria and the characteristics of participants are not reported in the registry record.
Intervention
Daily oral cocoa flavanol supplementation before surgery. The active-treatment description specifies 1,000 mg cocoa flavanol, using CocoaVia®, for 5 days before surgery, taken as 8 capsules in divided doses throughout the day.
Comparator
A placebo taken for 5 days before surgery, also as 8 capsules in divided doses throughout the day. The record describes the trial as placebo-controlled.
Primary question
Whether preoperative cocoa flavanol supplementation attenuates the surgery-evoked change in NFkB signaling in innate immune cells, measured using blood samples at 1 hour and 48 hours following surgery. The stated measurement is an arcsinh ratio comparing activity at a specified time with baseline activity before the intervention.
The study also aimed to collect preliminary patient-centered recovery outcomes and relate them to supplement intake and activation of the HMGB1-NFkB signaling axis. Listed secondary outcomes include plasma HMGB1, step count per minute, days to mild impairment, days to mild pain assessed by WOMAC pain scores, and days to half-max recovery from fatigue. The registry describes those aims but does not report their results in the information available for this analysis. The trial therefore poses a biological question about postoperative immune signaling alongside exploratory questions about recovery. The registry record does not establish what treatment effect was observed or how precisely any effect was estimated.
3. Trial Design
The registry classifies the study as a randomized, parallel-group trial with quadruple masking and Phase 1/Phase 2 designation. The brief summary calls it a double-blind, placebo-controlled proof-of-concept trial. These descriptions indicate masking, but the identities of the masked groups or roles are not reported in the registry record. The sponsor is Stanford University. The listed enrollment is 74, and the study status is completed.
Participants were assigned to cocoa flavanol supplementation or placebo. The active group was to receive a daily oral dose of 1,000 mg cocoa flavanol for 5 days before surgery, using 8 capsules in divided doses throughout the day. The placebo group was to follow the same described schedule with placebo capsules. The intended treatment period was therefore before surgery, while the primary outcome was measured after surgery relative to a baseline sample obtained before starting the intervention.
The registry lists a study start of 2017-04-17 and primary completion of 2018-12-14. These dates describe the registered study timeline; they do not establish when individual participants were enrolled or when each measurement was taken. The primary outcome is NFkB signaling in innate immune cells, expressed as an NFkB (p65) arcsinh ratio, with a timeframe of 1 hour and 48 hours following surgery. The record lists 6 outcome measures and 1 analysis, but does not provide a detailed statistical analysis plan or a numerical primary-outcome result.
The randomized design can support a comparison between assigned groups, but the registry record does not report the allocation sequence, allocation concealment, adherence summaries, or detailed participant flow. It also does not report a rationale for the enrollment target or the planned analysis model. Those omissions limit what can be concluded about the design’s operational details and about how the analysis was carried out.
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: A total of 32 participants that were consented/enrolled were dropped prior to randomization for a variety of reasons. Participants changed their minds, exclusion criteria were identified after consent but before study participation began, and early non-compliance with the survey completion were all reasons for withdrawal after consent.
Overall Study
| Stage | Active Treatment Group - Group A | Placebo Treatment Group - Group B |
|---|---|---|
| STARTED | 22 | 20 |
| COMPLETED | 22 | 20 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants with available data are included in the analysis. Three patients were excluded from the molecular analysis because of incorrect intake of the study medication, difficulties obtaining blood draws, and a non-recognized immune disorder. Exclusion of patients from the analyses was determined before unblinding.
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 | Active Treatment Group - Group A | Placebo Treatment Group - Group B | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 20 | 42 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 | 12 | 20 |
| Age, Categorical: >=65 years | Participants | 14 | 8 | 22 |
| Sex: Female, Male: Female | Participants | 14 | 11 | 25 |
| Sex: Female, Male: Male | Participants | 8 | 9 | 17 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 3 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 18 | 16 | 34 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 19 | 13 | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 5 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as NFkB Signaling in Innate Immune Cells, measured over 1 hour and 48 hours following surgery.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | NFkB (p65) arcsinh ratio |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is NFkB signaling in innate immune cells. The registry describes collecting blood samples to assess possible attenuation of surgery-evoked increases in signaling, with measurements at 1 hour and 48 hours following surgery. Results are expressed as an NFkB (p65) arcsinh ratio. The ratio compares an arcsinh-transformed activity value at a specified time with the corresponding value at baseline, before participants began the intervention.
In general, a baseline-referenced measure can express how a participant’s observed activity changes from their own pre-intervention value. That makes the endpoint relevant to the stated biological question: whether the postoperative change in signaling differs between the randomized groups. The arcsinh transformation is a way to represent measured values on a transformed scale; the registry does not explain why this transformation was selected or how its interpretation was established for this analysis.
The planned summary statistic is the median, with inter-quartile range as the measure of dispersion. In general, the median describes the middle of an ordered set of values, while the inter-quartile range describes the spread of the middle portion. These summaries can be useful when a distribution is skewed or includes values far from the center. They do not, by themselves, quantify the uncertainty in a between-group treatment effect.
No numerical results for the primary endpoint, between-group effect estimate, or confidence interval are reported in the registry record. The registry’s stated measurement plan therefore explains what the outcome represents, but does not show whether the groups differed or how precisely any difference was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registered objective is to assess whether preoperative cocoa flavanol attenuates surgery-evoked NFkB signaling in innate immune cells. The record identifies the measurement scale, baseline reference, and postoperative time points, but it does not report numerical primary-outcome results. Consequently, the posted information does not establish the direction, size, or precision of a between-group difference in NFkB signaling.
The primary outcome is summarized using medians and inter-quartile ranges. Those statistics describe the observed distributions, but a comparison of medians alone is not necessarily the same as an estimated treatment effect with uncertainty. A confidence interval, in general, gives a range of values compatible with the data and the method used to calculate it. No primary-outcome confidence interval or other numerical uncertainty measure is reported in the registry record. Without such results, it is not possible to assess how compatible the data are with effects of different sizes.
The trial’s stated purpose includes a proof-of-concept assessment and preliminary patient-centered outcomes. The registry lists plasma HMGB1, step count per minute, days to mild impairment, days to mild pain assessed by WOMAC pain scores, and days to half-max recovery from fatigue as secondary outcomes. However, their numerical results are not reported in the registry record. Their listing should not be mistaken for evidence that a particular recovery outcome changed or that a biological measure was associated with recovery.
The listed enrollment is 74, while the adverse-event record gives separate at-risk totals for the two groups and the primary-outcome description states that three patients were excluded from the molecular analysis for specified reasons. These details indicate that the analysis population may not be identical across outcome types. The registry does not provide a complete participant-flow account, the number analyzed at each primary time point, or the handling of missing measurements. The size and consequences of missing outcome data therefore cannot be assessed from this record.
There is also no reported numerical result for the primary comparison to reconcile with the intended effect or with the trial’s proof-of-concept aim. The record does not state whether the outcome was analyzed separately at each time point, whether the time points were combined, or how any repeated measurements were handled. Such details matter because they affect the interpretation of an estimated group difference and its uncertainty.
Overall, the registry record supports a description of the question, intervention, comparator, and endpoint, but not a quantitative conclusion about the primary result. A completed status means the study is marked completed in the registry; it does not supply the missing outcome findings. Interpretation should remain limited to the registered design and the results actually posted, rather than treating the intended effects as observed effects.
9. Statistical Methods Explained
The registry identifies the primary outcome as NFkB signaling in innate immune cells and specifies a median with inter-quartile range. It does not report the statistical test, model, treatment-effect measure, or confidence-interval method used for the primary comparison. The methods discussion below separates what the registry states from general statistical explanations; the latter are not claims about the analysis used in this trial.
What does the median describe?
In general, the median is the value at the center of ordered observations. It is less affected by very large or small observations than the arithmetic mean. The inter-quartile range describes the spread of the middle portion of the observed values. Reporting these quantities gives information about the distribution within a group, but it does not alone answer whether the groups differ. A comparison requires an analysis that accounts for the study design and states what contrast is being estimated.
The registry does not explain why the median was selected, whether the distribution was assessed before choosing summaries, or whether the analysis compared medians directly. It also does not report an effect estimate or uncertainty interval for NFkB signaling. Thus, the endpoint’s descriptive summary plan is identifiable, but the inferential method and the strength of evidence cannot be reconstructed from the registry record.
What does the arcsinh ratio represent?
The endpoint description says activity was expressed as an arcsinh-transformed value of a median measurement. It then describes changes over time using a ratio between the arcsinh value at a specified time and the arcsinh value at baseline, before the intervention. In general, transformation changes the scale on which values are represented, and a baseline-referenced measure is intended to express change relative to a pre-intervention measurement. The registry does not provide further detail about the transformation’s practical interpretation, assay properties, or the exact construction of the reported group summaries.
The outcome timeframe lists 1 hour and 48 hours following surgery. The record does not say whether each time point was tested as a separate primary comparison, whether the analysis used a repeated-measures model, or whether a single summary across times was prespecified. Those choices can affect the estimate and the uncertainty, so the stated time points do not by themselves define the statistical analysis.
Why can distributions matter?
In general, a statistical method should reflect the form and variability of the data. If observations are more variable than a model assumes, uncertainty can be understated unless the analysis accounts for that extra variation; this is one reason over-dispersion matters in suitable data settings. The registry does not report whether over-dispersion was assessed or whether it was relevant to the endpoint. It also does not report diagnostics, transformations beyond the stated arcsinh measure, or a model family. Those methods should not be inferred from the reported summary statistic.
Randomization creates a basis for comparing assigned groups, but it does not specify the estimator, analysis population, or missing-data method. In general, an analysis by randomized assignment preserves the original group comparison, while an analysis restricted to participants with available outcomes can be affected if data availability is related to participant characteristics or outcomes. The registry says participants with available data were included and identifies three exclusions from the molecular analysis, but the text describing exclusion handling is incomplete. It does not report a detailed intention-to-treat definition or sensitivity analysis.
What information would support a quantitative reading?
In general, an effect estimate with a confidence interval helps readers assess both the estimated difference and its precision. A p-value, if used, addresses compatibility with a specified null model under the analysis assumptions; it does not measure the probability that the null hypothesis is true, nor does it communicate the size of an effect. Neither a primary effect estimate, confidence interval, nor p-value is reported in the registry record. The registry also does not report the prespecified significance level or the test used.
The record states a planning-illustration framework based on two-sided significance level 0.05, equal allocation, a normal approximation, and fractions of an observed effect. These are explicitly described as planning illustrations computed from an observed effect, not as the trial’s own design. No numeric planning values or observed primary effect are included in the information available for this analysis. Such illustrations should not be interpreted as observed power or as proof that the trial was adequately powered.
Finally, general statistical interpretation should consider multiplicity when multiple outcomes or time points are examined. The record lists several outcomes and two postoperative primary-outcome time points, but does not report an adjustment plan or a hierarchy for testing them. It is therefore not possible to determine how multiplicity was handled. The absence of reported methods does not establish that a method was or was not used; it means the registry record does not describe it.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary outcome with measurements at 1 hour and 48 hours following surgery and lists secondary outcomes concerning plasma HMGB1, step count per minute, mild impairment, mild pain, and fatigue recovery. It does not report whether the primary time points were analyzed separately or jointly, whether secondary outcomes were exploratory or confirmatory, or whether any correction for multiple comparisons was planned or applied. The handling of multiplicity is therefore not reported in the registry record.
In general, evaluating multiple outcomes or time points can increase the chance of observing an apparently notable result by chance when each is tested separately. A prespecified hierarchy, a multiplicity adjustment, or an explicitly exploratory interpretation can help readers understand how to interpret a set of tests. No such approach is described in the record, so the statistical status of any individual result cannot be assessed from this information. The registry lists 6 outcome measures and 1 analysis, but that count does not explain how outcomes were grouped or tested.
For the molecular analysis, the record says that participants with available data were included and that three patients were excluded for incorrect medication intake, difficulty obtaining blood draws, and a non-recognized immune disorder. The description of the exclusion policy is incomplete. The record does not report the number of primary measurements missing at each time point, reasons for all missing data, imputation methods, or sensitivity analyses. It also does not provide a complete analysis-population definition or participant flow by outcome.
In general, missing data can matter when the likelihood of having a measurement is related to treatment assignment, participant characteristics, or the outcome itself. The available record does not permit an assessment of those relationships. The enrolled total and the molecular exclusions should not be treated as a complete accounting of participants analyzed for every outcome.
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 |
|---|---|---|---|
| Active Treatment Group - Group A | 1 | 22 | 4.5% |
| Placebo Treatment Group - Group B | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active Treatment Group - Group A | 0 of 22 |
| Placebo Treatment Group - Group B | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Active Treatment Group - Group A | 8 of 22 |
| Placebo Treatment Group - Group B | 7 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Active Treatment Group - Group A | Placebo Treatment Group - Group B |
|---|---|---|---|
| Pain | General disorders | 1 of 22 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Active Treatment Group - Group A | Placebo Treatment Group - Group B |
|---|---|---|---|
| lower extremity swelling | Vascular disorders | 5 of 22 | 1 of 20 |
| blisters at wound site | Skin and subcutaneous tissue disorders | 1 of 22 | 2 of 20 |
| nausea | Gastrointestinal disorders | 2 of 22 | 1 of 20 |
| bursitis | Infections and infestations | 0 of 22 | 2 of 20 |
| loss of appitite | Metabolism and nutrition disorders | 2 of 22 | 0 of 20 |
| pain | General disorders | 0 of 22 | 2 of 20 |
| tachycardia | Cardiac disorders | 1 of 22 | 1 of 20 |
| bladder pain | Renal and urinary disorders | 0 of 22 | 1 of 20 |
| dizziness | Nervous system disorders | 0 of 22 | 1 of 20 |
| elevated BP | Vascular disorders | 0 of 22 | 1 of 20 |
Serious events with the highest arm-level rate: pain (4.5%).
The adverse-event record lists 22 participants at risk in the active-treatment group and 20 in the placebo group. It records 1 serious adverse event in the active-treatment group and 0 in the placebo group; deaths are recorded as 0 in both groups. The record lists Pain as a top serious term at 4.5%. These are the figures posted in the registry, not an assessment of whether an event was caused by the intervention.
The record also lists 8 participants with other, non-serious adverse events in the active-treatment group and 7 in the placebo group. These counts describe participants affected, according to the registry fields, and should not be interpreted as event rates calculated from a complete safety dataset. The registry record does not provide descriptions of all events, their timing, duration, severity beyond the serious classification, or relatedness assessments.
In general, adverse-event counts are descriptive. Randomized group comparisons may be useful, but interpretation depends on the amount and completeness of follow-up, how events were collected and coded, and the uncertainty around the estimates. Those details are not reported in the registry record. The small at-risk group totals and absence of additional safety-analysis details mean the listed figures should be read narrowly as posted counts, not as evidence establishing a safety difference or the absence of one.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of preoperative cocoa flavanol supplementation with placebo, with postoperative NFkB signaling as the primary outcome. It gives the intended dose and schedule, identifies the baseline-referenced arcsinh measure, and specifies the postoperative measurement times. These details make the study question and planned biological endpoint understandable.
They do not, on their own, establish what happened to NFkB signaling. No numerical primary-outcome results, treatment-effect estimate, confidence interval, or p-value are reported in the registry record. It is therefore not possible to conclude from this record whether the groups differed, in which direction any difference went, or how precise a comparison would be.
The trial also set out to collect preliminary patient-centered recovery outcomes. The listed measures cover objective activity and several reported recovery milestones, as well as plasma HMGB1. However, outcome names and aims are not outcome findings. The record does not report numerical results for these measures or associations between recovery and the HMGB1-NFkB signaling axis. No conclusion about recovery outcomes or their relationship to the biological endpoint follows from the listed aims alone.
In general, an estimate should be interpreted in relation to its uncertainty, the analysis population, missingness, and the prespecified plan. Here, the registry record does not provide enough result or methods detail to make those assessments for the primary outcome. The listed enrollment, completed status, and available adverse-event counts do not substitute for the missing efficacy results.
The evidence described in the record is therefore evidence about a trial design and its intended questions, not a quantitative demonstration of a treatment effect. This distinction is especially important for a proof-of-concept study: an intended biological mechanism may motivate a study, but the rationale is not itself a result. Any stronger conclusion would require results and methods not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for connecting a mechanistic biological outcome with patient-centered recovery measures. NFkB signaling in innate immune cells is framed as a response to surgery, while the planned secondary outcomes include plasma HMGB1, step count per minute, and time to recovery milestones. The registry thus describes questions at different levels: a laboratory measure and outcomes closer to participants’ functional recovery.
The primary endpoint also uses a baseline-referenced, transformed measure at specified postoperative times. In general, a within-participant baseline can help describe change over time, while a randomized comparison is needed to distinguish a treatment-group pattern from changes that might occur in either group. How those repeated observations are summarized and compared matters for interpreting the treatment contrast. The registry record does not report that analysis, making the gap between a carefully specified measurement and an interpretable effect estimate especially visible.
There is also a useful distinction between a trial’s intended design and the evidence available for interpretation. The registry identifies randomization, masking, a placebo comparator, and a completed study, but does not include numerical primary results or a detailed statistical plan. Statistical appraisal depends on both design and reporting: a sound design can reduce some sources of bias, but readers still need outcome estimates, uncertainty, analysis-population details, and missing-data information to assess the findings.
The record’s combination of molecular exclusions and separate safety denominators further illustrates why denominators and analysis populations should be clearly described for each outcome. The listed enrollment is not enough to determine how many participants contributed to each measurement or how exclusions affected the analysis. This matters when interpreting small-group clinical research, where limited outcome availability can make estimates less precise and more sensitive to analytic choices.
As posted, the record is informative about the scientific question and planned measurements but incomplete as a report of statistical results. That distinction is central to evidence appraisal: a protocol-like description cannot answer a treatment-effect question without the observed results and their uncertainty.
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 most important limitation for interpreting this trial is that numerical results for the primary endpoint are not reported in the registry record. The record therefore does not permit assessment of the observed group difference, its direction, or its precision. Numerical findings for the listed secondary outcomes are also not reported in the registry record, preventing interpretation of the planned patient-centered and plasma HMGB1 measures.
The description of the primary analysis population is incomplete. It states that participants with available data were included and identifies three molecular-analysis exclusions, but the explanation ends before fully describing the exclusion approach. A complete participant-flow account, counts analyzed at each time point, and reasons for any additional missing measurements are not reported in the registry record. This leaves uncertainty about the exact analysis populations and the potential impact of unavailable data.
Important statistical-plan details are also not reported in the registry record. These include the primary comparison method, whether postoperative time points were analyzed separately, the approach to repeated measurements, the prespecified effect measure, and the method for quantifying uncertainty. The record does not describe how multiplicity across outcomes and time points was handled, or provide sensitivity analyses. These omissions make it difficult to assess whether the analysis directly addressed the stated primary question.
The registry gives a median and inter-quartile range for the endpoint, but does not explain the rationale for those summaries or provide information about assay performance and measurement variability. It also does not report detailed eligibility criteria, participant characteristics, adherence results, or allocation procedures. These details may affect judgments about representativeness, implementation, and the interpretation of an observed result, but cannot be evaluated from the record as described.
Finally, the listed enrollment and completed status do not provide a sample-size justification or evidence that a target precision was achieved. The planning-illustration assumptions are not described as the trial’s own design. No conclusion about the adequacy of the planned sample size can be drawn from those assumptions or from enrollment alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery — NCT03123068.
- Registry record last updated 2022-10-13; status last verified 2022-09.
- Results first posted 2021-11-17.
- 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
The registry describes a completed randomized, parallel-group, placebo-controlled study sponsored by Stanford University, with quadruple masking and Phase 1/Phase 2 designation. Listed enrollment is 74. The registered study start is 2017-04-17, and primary completion is 2018-12-14.
The active group was assigned daily oral CocoaVia® containing 1,000 mg cocoa flavanol for 5 days before surgery, taken as 8 capsules in divided doses throughout the day. The placebo group was assigned placebo on the same stated schedule. The primary outcome is NFkB signaling in innate immune cells, expressed as an arcsinh ratio and summarized using the median and inter-quartile range at 1 hour and 48 hours following surgery.
The registry lists secondary outcomes concerning plasma HMGB1, step count, mild impairment, mild pain, and fatigue recovery. It also reports a molecular-analysis exclusion of three patients for specified reasons and provides adverse-event counts by group. Numerical primary and secondary outcome results, a detailed statistical analysis plan, and complete missing-data information are not reported in the registry record.