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 Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes (NCT03244722), a randomized na study. The primary outcome is Preconception Weight Loss.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03244722 |
| Phase | NA |
| Condition | Obesity; Familial, Pregnancy Related |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 147 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan |
| Results posted | Yes |
2. Clinical Question
Population
Women with obesity considering pregnancy are the population relevant to the randomized dietary comparison. The registry also describes healthy-weight women followed in parallel; they received no dietary intervention before conceiving. The enrollment was 147.
Intervention
The intervention was a very-low energy diet (VLED). The arm description says participants adopted a very-low energy diet before conceiving.
Comparator
The randomized comparator was standard of care (SOC): dietary education and advice to incorporate a low-calorie, food-based diet. The healthy-weight group was followed in parallel and is described separately from the dietary intervention arms.
Primary question
The primary question concerns change in BMI, measured in kg/m2, from baseline to conception, up to 68 weeks post enrollment. The registry record identifies this as preconception weight loss, but does not report the result of the primary-outcome analysis.
The study hypothesis was that aggressive preconception weight loss in women with obesity could improve maternal metabolic health and the intrauterine environment, with potential effects on fetal growth and clinical fetal and infant outcomes. That statement describes the rationale and hypothesis, not an established finding. The primary endpoint focuses on BMI change after dietary intervention; fetal growth by ultrasound, ponderal index, and mode of delivery are listed as secondary outcomes.
The registry record identifies the allocation as randomized and the design as parallel, with no masking. It does not give a posted comparison of the VLED and SOC groups on the primary endpoint. Consequently, the stated clinical question can be described, but the posted record does not establish whether BMI change differed between the randomized groups or how precisely any difference was estimated.
3. Trial Design
This completed study is registered as NCT03244722 and is sponsored by the University of Michigan. Its title concerns maternal metabolic and molecular changes induced by preconception weight loss and their effects on birth outcomes. The registry identifies the trial as randomized, with a parallel model and no masking. The phase is listed as NA. Enrollment was 147.
The arm descriptions distinguish obese participants assigned to a very-low energy diet from obese participants receiving standard of care. The VLED arm was to adopt a very-low energy diet. The SOC arm was to receive dietary education and advice to incorporate a low-calorie food-based diet. A healthy-weight group, labeled LEAN, was followed in parallel without a dietary intervention prior to conceiving. The record does not describe the healthy-weight group as part of the randomized comparison, so its role should not be conflated with the VLED-versus-SOC contrast.
The primary outcome is described as BMI change after dietary intervention, measured from baseline to conception, with the timeframe extending up to 68 weeks post enrollment. The secondary outcomes include fetal growth assessed by ultrasound, ponderal index, and mode of delivery. The registry lists 11 outcome measures, but the posted record does not include analysis results for those measures.
The recorded start date is 2018-04-10, the primary completion date is 2025-06-14, and the status is completed. Completion status indicates that the study is marked completed in the registry; it does not itself establish that results were posted or that the primary question was answered. The registry record reports no analyses for the outcome measures. Details such as the randomization procedure, allocation concealment, adherence, and analysis populations are 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.
Overall Study
| Stage | Obese - Very Low Energy Diet (VLED) | Obese - Standard of Care (SOC) | LEAN |
|---|---|---|---|
| STARTED | 49 | 45 | 53 |
| COMPLETED | 22 | 27 | 35 |
| NOT COMPLETED | 27 | 18 | 18 |
Reasons for not completing this period:
| Reason | Obese - Very Low Energy Diet (VLED) | Obese - Standard of Care (SOC) | LEAN |
|---|---|---|---|
| Did not become pregnant within 12 month window | 13 | 6 | 10 |
| Withdrawal by Subject | 7 | 3 | 2 |
| Lost to Follow-up | 3 | 4 | 2 |
| Removed from study by NIH, due to inadequate time for post-conception follow-up before study end | 4 | 5 | 4 |
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.
Population: Data is presented for all participants who completed the study.
| Characteristic | Unit | Obese - Very Low Energy Diet (VLED) | Obese - Standard of Care (SOC) | LEAN | Total |
|---|---|---|---|---|---|
| Participants analysed | 22 | 27 | 35 | 84 | |
| Age, Continuous | years | 31.8 (SD 4.1) | 32.1 (SD 3.4) | 31.0 (SD 4.0) | 31.6 (SD 3.8) |
| Sex: Female, Male: Female | Participants | 22 | 27 | 35 | 84 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 0 | 34 | 37 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 19 | 27 | 1 | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 19 | 21 | 30 | 70 |
| Race/Ethnicity, Customized: Black | Participants | 1 | 3 | 1 | 5 |
| Race/Ethnicity, Customized: Other | Participants | 2 | 3 | 4 | 9 |
| Region of Enrollment: United States | Participants | 22 | 27 | 35 | 84 |
6. Primary Endpoint
The registry lists the primary outcome as Preconception Weight Loss, measured over Baseline to conception (up to 68 weeks post enrollment).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | kg/m2 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is preconception weight loss, operationalized as change in BMI in kg/m2 from baseline to conception, up to 68 weeks post enrollment. BMI is calculated from measured height and weight. The description says trained staff measured height and weight using a wall-mounted precision stadiometer and calibrated digital scale, recording height to the nearest .1cm and weight to the nearest .1kg.
BMI is a continuous measure, and the registry specifies that the primary outcome is summarized as a mean with standard deviation. In general, a continuous endpoint can describe the average change in a group while retaining information about the distribution of measured values. The standard deviation describes variability among observations around the mean; it is not a measure of uncertainty in the estimated mean.
The endpoint is relevant to the intervention because it captures change in body size during the preconception period, which is the period the dietary intervention targets. It is not itself a direct measure of maternal metabolic health, fetal growth, or infant outcomes. Those broader questions motivate the study, and fetal growth assessed by ultrasound, ponderal index, and mode of delivery are listed as secondary outcomes.
The registry record specifies the outcome and measurement approach but does not report group means, mean changes, a between-group estimate, or an uncertainty interval for the primary endpoint. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. Thus the endpoint's definition is available, while the result needed to quantify the randomized contrast is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted registry information establishes the study question, the intervention descriptions, and the planned primary measure. It does not provide an estimated BMI change for the VLED or SOC group, a direct comparison between those groups, or a confidence interval. The registry reports zero analyses. As a result, no direction or size of the primary treatment contrast can be interpreted from this record.
The status is completed, but completion and outcome reporting are distinct. A completed status is not evidence that the posted record contains the endpoint results. Likewise, the study hypothesis about maternal metabolic health, the intrauterine environment, fetal growth, and later susceptibility to obesity and cardiometabolic disease is a rationale, not a result. None of those effects can be inferred from the record's description alone.
The record identifies a randomized comparison between obese participants assigned to VLED and SOC, while the healthy-weight group was followed in parallel without preconception dietary intervention. These groups answer different questions. The randomized contrast is the appropriate basis for estimating the effect of assignment to VLED relative to SOC, subject to the conduct and analysis of the trial. A comparison involving the LEAN group would not be the same randomized contrast, and the record does not report an analysis of that comparison.
The safety counts are descriptive registry entries. Serious adverse events affected 2 of 49 participants in the VLED group, 0 of 45 in the SOC group, and 1 of 53 in the LEAN group. Other adverse events affected 10 of 49, 29 of 45, and 31 of 53 participants, respectively. Deaths were recorded as 0 in each group. The registry does not provide an inferential comparison of these counts, event timing, exposure-adjusted rates, or a fuller account of ascertainment. These entries therefore should not be treated as a complete comparative safety analysis.
Planning illustrations are distinct from trial findings. The stated sample-size assumptions use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such illustrations concern hypothetical planning under specified assumptions; they are not observed power and cannot replace an estimate and uncertainty interval from the trial. The registry does not report the primary analysis needed to assess the observed BMI contrast.
9. Statistical Methods Explained
The registry describes a randomized, parallel trial with no masking. Random allocation is intended, in general, to make treatment groups comparable at the start with respect to measured and unmeasured characteristics, apart from chance imbalances. A parallel design assigns participants to a group that is followed over the study period, rather than describing a sequence in which each participant receives each intervention. The record does not report the randomization procedure or allocation concealment, so those operational details cannot be assessed from the registry entry.
What does the primary measure represent?
BMI is a continuous outcome calculated from height and weight. The primary measure is described as change from baseline to conception, in kg/m2, with the timeframe extending up to 68 weeks post enrollment. A change score expresses how a participant's measurement differs between the stated assessment points. In general, comparing average change between randomized groups can summarize the contrast of interest, but interpretation depends on how the outcome was analyzed and how many participants contributed measurements. The registry record gives no such analysis details or estimates.
The specified summary is mean and standard deviation. In general, the mean describes the center of a set of measurements, while the standard deviation describes their spread. A confidence interval, if reported for a group contrast, would describe the uncertainty around the estimated contrast under the analysis assumptions. It would not mean that individual outcomes fall within that interval, nor would it by itself establish clinical importance. No confidence interval for the primary comparison is reported in the registry record.
Why can variability matter?
When data are more variable, an average difference is estimated less precisely, all else equal. In general, standard methods for continuous outcomes often rely on assumptions about the distribution of residual variation. If variability differs across groups or the distribution has features not captured by a simple model, methods that account for those features may be considered. The registry record does not report diagnostics, a modeling approach, or a discussion of distributional assumptions, so there is no basis to say which methods were used.
What can the randomization support?
For a properly conducted randomized comparison, an analysis based on assignment can estimate the effect of being assigned to VLED rather than SOC. In general, preserving participants in their assigned groups helps retain the comparability created by randomization, even if adherence varies. A per-protocol analysis instead focuses on participants meeting specified adherence criteria and can be more vulnerable to differences between those who do and do not adhere. The registry record does not report whether an intention-to-treat, per-protocol, or other analysis population was used. The intervention descriptions alone do not establish adherence or treatment received.
The LEAN group has a different role from the randomized dietary comparison: its description says healthy-weight women were followed in parallel and received no dietary intervention before conceiving. In general, comparisons between groups that were not randomized against one another can reflect baseline differences as well as any exposure or group distinction. The record does not report an adjusted comparison involving LEAN, and no such causal interpretation should be assumed.
How should the planning illustrations be understood?
The registry states that planning illustrations were computed from the observed effect, not from the trial's own design. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the stated quantities are participants per arm for 80% power or participants per arm for 90% power. In general, a sample-size calculation estimates the amount of information needed to detect a specified effect under its assumptions. It does not tell whether a study actually had that power after completion, and a planning illustration based on an observed effect should not be read as observed power.
The record does not report the trial's original sample-size justification or its assumed target effect. It also does not report an observed primary effect estimate in the outcome results. Consequently, the illustrations cannot be used to reconstruct the original design rationale or to assess the precision of the actual result. The stated assumptions make clear that the illustrations are conditional calculations, not a substitute for the primary analysis.
What is missing from the analysis record?
The registry reports zero analyses, despite listing 11 outcome measures. It does not report a statistical model, covariate adjustment, missing-data method, handling of multiple outcomes, or analysis population. It also does not report an interim analysis plan or whether any interim analyses occurred. These are not minor details: they affect what estimate is being made, how uncertainty is calculated, and how the reported result should be interpreted. Without the analysis record, the trial's methods cannot be reconstructed beyond the design and outcome descriptions stated in the registry.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, including the primary BMI outcome and secondary outcomes concerning fetal growth assessed by ultrasound, ponderal index, and mode of delivery. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. The record does not report a multiplicity strategy, such as a prespecified hierarchy of outcomes or an adjustment for multiple comparisons. It would therefore be inappropriate to assume that a particular adjustment was used or to interpret unreported significance tests.
Missing-data handling is not reported in the registry record. The entry does not state how missing BMI measurements were handled, whether the number of participants with endpoint data differed by group, or whether any imputation or sensitivity analysis was performed. In general, missingness can affect an estimate when the participants with observed outcomes differ from those without observed outcomes. The direction and extent of any such effect cannot be determined without information about missingness and the analysis.
Analysis populations are also not reported. The entry does not say whether the primary analysis included all randomized participants according to assigned group, only participants with observed endpoint data, or a group defined by adherence. These choices can answer different questions and can affect comparability. The record's arm descriptions do not resolve which population was analyzed.
Interim analyses and stopping rules are not reported in the registry record. No assumptions about them can be made from the completed status. Because the record reports zero analyses, it contains no primary-outcome estimate to interpret in relation to multiplicity, missingness, or analysis populations.
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 |
|---|---|---|---|
| Obese - Very Low Energy Diet (VLED) | 2 | 49 | 4.1% |
| Obese - Standard of Care (SOC) | 0 | 45 | 0.0% |
| LEAN | 1 | 53 | 1.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Obese - Very Low Energy Diet (VLED) | 0 of 49 |
| Obese - Standard of Care (SOC) | 0 of 45 |
| LEAN | 0 of 53 |
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 |
|---|---|
| Obese - Very Low Energy Diet (VLED) | 10 of 49 |
| Obese - Standard of Care (SOC) | 29 of 45 |
| LEAN | 31 of 53 |
Most frequent serious adverse event terms
| Event term | Organ system | Obese - Very Low Energy Diet (VLED) | Obese - Standard of Care (SOC) | LEAN |
|---|---|---|---|---|
| gallstones | Hepatobiliary disorders | 2 of 49 | 0 of 45 | 0 of 53 |
| supraventricular tachycardia | Cardiac disorders | 0 of 49 | 0 of 45 | 1 of 53 |
| fetal hydrops | Pregnancy, puerperium and perinatal conditions | 0 of 49 | 0 of 45 | 1 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Obese - Very Low Energy Diet (VLED) | Obese - Standard of Care (SOC) | LEAN |
|---|---|---|---|---|
| High blood pressure (gestational hypertension) | Pregnancy, puerperium and perinatal conditions | 6 of 49 | 11 of 45 | 3 of 53 |
| Decreased fetal movement with reassuring nonstress test (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 1 of 49 | 2 of 45 | 7 of 53 |
| Gestational Diabetes | Pregnancy, puerperium and perinatal conditions | 1 of 49 | 3 of 45 | 3 of 53 |
| Vaginal bleeding (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 1 of 49 | 2 of 45 | 2 of 53 |
| Headache (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 0 of 49 | 3 of 45 | 2 of 53 |
| Contractions without being in labor | Pregnancy, puerperium and perinatal conditions | 0 of 49 | 4 of 45 | 0 of 53 |
| Pregnancy loss | Pregnancy, puerperium and perinatal conditions | 0 of 49 | 2 of 45 | 2 of 53 |
| Heart palpitations or tachycardia (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 1 of 49 | 1 of 45 | 2 of 53 |
| Concerns of high blood pressure with normal blood pressures in ED (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 2 of 49 | 1 of 45 | 0 of 53 |
| Back pain (during pregnancy) | Pregnancy, puerperium and perinatal conditions | 0 of 49 | 2 of 45 | 1 of 53 |
Serious events with the highest arm-level rate: gallstones (4.1%), supraventricular tachycardia (1.9%), fetal hydrops (1.9%).
The registry lists serious adverse events affecting 2 of 49 participants in the VLED group, 0 of 45 participants in the SOC group, and 1 of 53 participants in the LEAN group. It lists other adverse events affecting 10 of 49 participants in VLED, 29 of 45 in SOC, and 31 of 53 in LEAN. Deaths are recorded as 0 for each group. These are counts of participants affected as represented in the registry entry, not an inferential comparison of risk.
The serious-event terms listed include gallstones at 4.1%, supraventricular tachycardia at 1.9%, and fetal hydrops at 1.9%. The registry listing does not identify these terms by treatment arm in the information reported. It should not be assumed that the percentages describe rates in a particular arm or that the list represents every serious event.
In general, safety counts need context: definitions, observation periods, ascertainment procedures, severity grading, and the relationship of events to treatment can affect interpretation. Those details and a statistical comparison are not reported in the registry record. The counts therefore describe what was entered, but do not by themselves establish a comparative safety profile.
12. What the Result Does, and Does Not, Mean
The registry record documents a study designed to examine preconception BMI change after a dietary intervention among women with obesity. It identifies VLED and SOC as the randomized dietary approaches and describes a healthy-weight group followed in parallel. It also identifies birth-related outcomes as part of the study's broader interest. These registry entries establish the research question and design features, not the answer to the question.
The record does not report group-level primary endpoint results or a VLED-versus-SOC estimate for BMI change. It therefore cannot show how much BMI changed, whether average changes differed between the randomized groups, or how precisely a difference was estimated. No claim about the direction, size, or statistical significance of the primary effect follows from the outcome definition or the study hypothesis.
The biological and clinical rationale in the registry describes proposed pathways from preconception weight loss to maternal metabolic health, fetal growth, and later health. A rationale is not evidence that those pathways changed in this study. The record lists fetal growth assessed by ultrasound, ponderal index, and mode of delivery as secondary outcomes, but does not report their analysis results. It also does not report results for future susceptibility to obesity or cardiometabolic disease.
Safety counts are available, but the registry entry does not give the context needed for a complete comparative interpretation. They should be read descriptively, with the distinction between the randomized dietary groups and the parallel healthy-weight group kept clear. The absence of reported analyses means that no uncertainty interval, adjusted estimate, or formal safety comparison can be assessed.
Accordingly, this registry entry supports a description of the study's design, endpoint, stated hypothesis, and recorded adverse-event counts. It does not support a conclusion about the efficacy of either dietary approach or a definitive conclusion about comparative safety. Those questions require outcome analyses and sufficient detail about how the data were collected and analyzed.
13. Why This Trial Matters Statistically
This trial raises a statistically important question about how to evaluate a preconception intervention when the endpoint is measured over a period extending from baseline to conception. The primary measure is a continuous BMI change, and the record specifies both the measurement process and the timeframe. Clear outcome definitions are important because they determine what a group contrast represents and which observations can contribute to it.
The design also makes the comparison structure important. VLED and SOC are described as the randomized groups among participants with obesity, while LEAN is a healthy-weight group followed without dietary intervention. Keeping those roles distinct is central to interpretation: a randomized comparison can support a different inference from a comparison with a parallel group that was not described as randomized to the intervention.
The record illustrates why design information and results reporting must be considered together. It is marked completed and contains enrollment and adverse-event counts, yet it reports zero analyses and no primary-outcome estimate. Without an effect estimate and uncertainty measure, readers cannot assess the size or precision of the primary contrast. A completed study status does not supply that missing statistical evidence.
The planning assumptions also highlight the difference between design calculations and observed results. A sample-size illustration based on an observed effect and specified assumptions can help explain hypothetical planning, but it cannot substitute for the trial's own design rationale or an analysis of the trial data. Statistical significance, precision, and clinical relevance are separate considerations; the registry record does not provide the primary results needed to assess them.
For clinical researchers and biostatisticians, the key lesson is that a well-specified endpoint and a randomized design do not, by themselves, make the effect interpretable. Analysis populations, missing-data methods, multiplicity handling, and outcome estimates are also needed. Their absence from this registry entry limits what can be concluded from the posted record.
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 central limitation for statistical interpretation is that the registry record reports no analyses. Although the primary outcome is defined as BMI change from baseline to conception, no group estimates, between-group contrast, or uncertainty interval are reported. The primary outcome also has several categories or time points and is not reduced to one comparison, leaving the specific analysis contrast unresolved in the record.
The entry does not report details about the randomization procedure, allocation concealment, participant flow, adherence, or treatment discontinuation. It does not report which participants contributed primary endpoint data or how missing values were handled. Without these details, the completeness of the outcome data and the impact of missingness cannot be evaluated.
The analysis plan is not described in enough detail to identify the statistical model, covariate adjustment, or analysis population. Multiplicity handling across the 11 outcome measures is not reported, nor are interim analyses or stopping rules. These omissions prevent a full assessment of how the reported design was translated into an analysis; in this record, no analysis is posted to assess.
The healthy-weight LEAN group is described as followed in parallel, without a dietary intervention before conceiving. The registry does not report its role in a formal analysis. Since it is not described as randomized against the intervention arms, its results should not be treated as equivalent to the randomized VLED-versus-SOC contrast.
The adverse-event information is limited to participant counts, deaths, and a short list of serious-event terms with percentages. The record does not describe event ascertainment, timing, attribution, or an inferential comparison. The sample-size assumptions describe planning illustrations, but the original sample-size justification is not reported in the registry record. Together, these gaps restrict interpretation to the study description and the counts explicitly recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes — NCT03244722.
- Registry record last updated 2026-09-04; status last verified 2026-07.
- Results first posted 2026-09-04.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03244722 is a completed, randomized, parallel study sponsored by the University of Michigan, with no masking and enrollment of 147. The recorded start date is 2018-04-10 and the primary completion date is 2025-06-14. The study compares a very-low energy diet with standard dietary care among women with obesity and follows a healthy-weight group in parallel without a preconception dietary intervention.
The primary outcome is BMI change in kg/m2 from baseline to conception, up to 68 weeks post enrollment, summarized as a mean with standard deviation. Listed secondary outcomes include fetal growth assessed by ultrasound, ponderal index, and mode of delivery. The registry reports zero analyses, so the primary endpoint result and other outcome analyses are not reported in the registry record.
Safety entries include serious and other adverse-event counts and zero deaths in each group. The record does not report the statistical analysis plan, missing-data methods, analysis populations, or multiplicity handling. The posted information supports a description of the design and recorded counts, but not a conclusion about the primary treatment contrast.