Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS (NCT00559962), a randomized phase 2 study. The primary outcome is Absolute Change From Baseline in Percent Hepatic Fat.

2. Clinical Question

The endpoint is a continuous measure of liver fat assessed by magnetic resonance spectroscopy. The primary result describes the mean absolute change from baseline, rather than a proportion of participants who crossed a threshold or experienced a clinical event. In the posted comparison, the mean change was 4.72 for AEGR-733 5 mg and 0.03 for placebo. The recalculated unadjusted mean difference is 4.69, with a 95% confidence interval from 2.091 to 7.289 and p < 0.001.

The study record describes eight treatment arms, including placebo, several AEGR-733 doses, and three combination regimens. The primary outcome results available for the main comparison concern placebo and AEGR-733 5 mg. The secondary outcome record contains results across the listed arms, but only selected comparisons have sponsor-reported analyses. These distinctions matter: the clinical question is broader than the single contrast with full primary results, and the posted comparison does not establish the result of every dose or combination.

3. Trial Design

This was a randomized, triple-masked, parallel-group phase 2 study with placebo control. Its title describes evaluation of low doses of the MTP-inhibitor AEGR-733 on hepatic fat accumulation measured by magnetic resonance spectroscopy. The condition listed is hyperlipidemia. The study status is completed; the registry gives 2007-10 as the start and 2008-10 as the primary completion. Enrollment is reported as 260.

The registry describes eight arms: placebo; AEGR-733 2.5 mg, 5 mg, 7.5 mg, and 10 mg; and AEGR-733 5 mg combined with atorvastatin 20 mg, fenofibrate 145 mg, or ezetimibe 10 mg. The primary posted outcome comparison is placebo versus AEGR-733 5 mg. The secondary outcome data describe results for all eight arms, while sponsor-reported comparison analyses are available for placebo versus AEGR-733 2.5 mg and placebo versus AEGR-733 5 mg.

The primary outcome is the absolute change from baseline in percent hepatic fat, measured at baseline and after 12 weeks on study drug. The specified analysis population is ITT. The registry identifies the outcome as a mean and reports standard deviations for the arm-level results.

The registry record does not report the original sample-size justification, the intended allocation ratio, the specific roles covered by triple masking, or the detailed conduct of randomization. It also does not report a full protocol-level statistical analysis plan or an account of participant flow. The reported enrollment should therefore not be treated as the number contributing data to each outcome comparison: the arm-specific outcome denominators are smaller and vary across the posted results.

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: Subjects underwent a 5- to 9-week screening washout period to determine study eligibility and to wash-out patients of all lipid-lowering therapies; patients were required to have low-density lipoprotein cholesterol (LDL-C) between 100 and 190 mg/dL (average of 2 visits during screening) and hepatic fat less than 6.2% for randomization.

Only the first 6 of 8 groups are shown.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: ITT

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.

Only the first 6 of 9 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Absolute Change From Baseline in Percent Hepatic Fat, measured over Baseline and 12 weeks on study drug.

The primary endpoint is absolute change from baseline in percent hepatic fat, with measurement at baseline and 12 weeks on study drug. Magnetic resonance spectroscopy is the stated measurement method. The outcome is continuous, and the registry reports mean changes and standard deviations. This makes the endpoint a measure of the average change in the selected liver-fat measure within each posted arm, rather than a count of participants meeting a response definition.

In general, a continuous endpoint can retain information about the range of measured values instead of reducing results to categories. A mean difference then describes the contrast between group averages, while a standard deviation describes the spread of individual observations around an average. Neither statistic alone describes every participant's outcome or establishes the clinical importance of a difference.

The registry labels the primary analysis population as ITT, but does not report further details about how that population was defined or handled in the analysis. The endpoint description also does not establish whether a numerical increase or decrease corresponds to a clinically preferred outcome. The posted numbers should therefore be read as changes in the measured percent hepatic fat and as a between-arm statistical contrast, without inferring a clinical benefit from the direction alone.

7. Results Posted in the Registry

• AEGR-733 5 mg: mean 4.72 versus 0.03 on control; difference 4.69 (95% CI 2.09 to 7.29), standardized effect d = 1.07; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Absolute Change From Baseline in Percent Hepatic Fat

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AEGR-733 2.5 mg: mean 4.95 versus 0.03 on control; difference 4.92 (95% CI 2.16 to 7.68), standardized effect d = 0.98; z-test p = <0.001.
  • AEGR-733 5 mg: mean 4.72 versus 0.03 on control; difference 4.69 (95% CI 2.09 to 7.29), standardized effect d = 1.07; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for AEGR-733 2.5 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for AEGR-733 5 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcome record follows the same general measure of absolute change from baseline in percent hepatic fat and reports arm-level results across the dose and combination groups. The displayed means vary across these groups. This broad pattern provides additional descriptive context around the primary placebo-versus-AEGR-733 5 mg comparison, but it does not establish that one dose or combination is better than another. The posted sponsor comparisons are limited to placebo versus AEGR-733 2.5 mg and placebo versus AEGR-733 5 mg.

Secondary results can help show whether observations are confined to one treatment contrast or appear across a wider set of arms. However, the variety of doses and combinations means that comparisons should be interpreted in light of their separate denominators, variability, and analysis methods. The registry record does not report a complete inferential analysis for every arm-to-arm contrast. Descriptive differences between arm means are not equivalent to formal evidence of a difference between those arms.

Unadjusted secondary results carry less weight as confirmatory evidence when multiple outcomes or comparisons may have been examined. In general, repeated testing creates more opportunities for chance findings, and a prespecified multiplicity strategy helps control the interpretation of those tests. The registry record does not report such a strategy. The secondary findings are therefore best treated as supportive description rather than as independent confirmation of a treatment effect. They also do not resolve the clinical meaning of a change in the measured endpoint, for which no threshold is reported.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Absolute Change From Baseline in Percent Hepatic Fat

9. Statistical Interpretation

10. Statistical Methods Explained

The posted results combine arm-level summaries with comparison estimates. The arm-level means describe the average absolute change from baseline in percent hepatic fat for each analyzed group. Standard deviations describe the spread of participant measurements around those means. The recalculated comparison is an unadjusted difference between the two group means, with a confidence interval and p-value derived from the posted summary statistics. This is distinct from the sponsor-reported ANOVA analysis of final values.

What does a mean difference represent?

In general, a mean difference is a contrast between two group averages on the original measurement scale. Here, it is expressed in the endpoint's unit, percent of hepatic fat. A positive value indicates that the mean in the AEGR-733 5 mg group is numerically higher than the mean in the placebo group for the reported change measure. The difference does not describe the distribution of individual outcomes, and it does not tell whether a particular participant experienced a change of that size.

The recalculated estimate is labeled unadjusted because it compares the posted summaries without accounting for other variables in a model. It should not be assumed to reproduce every feature of the sponsor's analysis. The sponsor reports ANOVA and describes its parameter as a mean difference in final values. The registry record does not report enough detail about the model, covariates, or handling of baseline measurements to explain precisely how that analysis was specified.

How should the p-value be read?

In general, a p-value measures how unusual the observed data, or data more extreme, would be under a stated null hypothesis and the assumptions of the analysis. A value reported as p < 0.001 indicates that the p-value falls below that threshold. It is not the probability that the null hypothesis is true, nor the probability that the finding arose by chance. It also does not measure the size or clinical importance of an effect.

The reported p-values are unadjusted for multiplicity in the recalculated comparisons. The registry record does not report whether the sponsor adjusted for testing multiple arms, outcomes, or contrasts. When many comparisons are examined, the chance of at least one nominally small p-value can increase; accounting for that concern generally requires a prespecified analysis strategy. The record does not establish which inferential results were designated as confirmatory.

Why does variation matter?

In general, the standard deviation measures variability among participant values, while the standard error measures uncertainty in an estimated mean. These are different quantities. A standard deviation can be large even when the mean is estimated with some precision, because the amount of uncertainty also depends on the amount of outcome information available. The posted primary comparison has standard deviations of 1.814 in placebo and 6.297 in the AEGR-733 5 mg group. The unequal spreads make it especially important not to assume that a common variability pattern applies across groups without checking the analysis assumptions.

In general, over-dispersion refers to greater variability than a statistical model expects. It can make standard errors and inferential results unreliable if the model does not accommodate the actual variability. The registry does not report an over-dispersion assessment, and it does not identify this as a count outcome; the primary endpoint is continuous. Thus, the general concern is to use a model appropriate to the observed distribution and variability, not to infer that over-dispersion was present in this trial.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable with respect to measured and unmeasured characteristics, on average. It supports a causal interpretation when allocation, follow-up, outcome measurement, and analysis are conducted appropriately. The registry identifies the study as randomized, but does not report details of sequence generation or concealment. The posted summary statistics alone cannot verify whether all potential sources of bias were avoided.

Masking is recorded as triple, but the record does not specify which people or groups were masked. Masking can reduce some forms of bias in treatment delivery, outcome assessment, or participant reporting, depending on who is masked and how the procedures are implemented. The available description is not detailed enough to assess those safeguards independently.

The listed primary analysis population is ITT. In general, an intention-to-treat approach analyzes participants according to their randomized groups, but the registry does not give the operational definition used for this study or describe how missing outcome measurements were addressed. Consequently, the ITT label should be reported as stated, without assuming that every randomized participant contributed an observed endpoint value.

11. Confidence Intervals and Precision

The recalculated 95% confidence interval for the unadjusted mean difference between AEGR-733 5 mg and placebo runs from 2.091 to 7.289. It is centered around an estimated difference of 4.69, but it is not a guarantee that the true difference falls within that interval. In general, a confidence interval is a range produced by a method that, under repeated use and its assumptions, would cover the underlying quantity at the stated rate.

The interval does not describe the range of participant-level changes. The reported standard deviations show that individual measurements varied within each arm, while the interval quantifies uncertainty in the estimated group contrast. The two summaries answer different questions and should not be substituted for one another.

The sponsor-reported ANOVA interval for the same comparison is 2.30 to 7.07, also at the 95% level. Its reported mean difference is 4.68. These estimates and intervals are close to, but not identical with, the unadjusted recalculation. Because the record does not fully describe the sponsor's model, the reason for the differences is not reported in the registry record. Both analyses report p < 0.001.

Precision depends on the amount and variability of outcome information as well as on the analysis method. The arm-specific outcome denominators are 31 for placebo and 24 for AEGR-733 5 mg, and the standard deviations differ. The interval should be interpreted in light of those data and the unadjusted analysis, rather than as proof of a precise clinical effect. The registry does not report a threshold for a clinically meaningful difference, so statistical precision cannot determine whether the estimated magnitude matters clinically.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size values are planning illustrations based on the observed comparison, not the trial's original enrollment plan. They are reported as participants per arm, not as total events. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect. The trial's own original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the estimated participants per arm for a planning scenario designed to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions were correct. The 90% power column gives the corresponding planning amount for a 90% chance. These are prospective planning quantities, not a measure of the probability that the completed trial detected a true effect.

The rows that plan for 100%, 75%, or 50% of the observed effect illustrate how the assumed effect size changes the required sample. A smaller target effect generally requires more participants to distinguish it from random variation at the same significance level and planned power. The displayed curve applies the same planning logic across effect sizes; it should be read as an illustration of design sensitivity, not as a description of observed outcomes.

This is not observed power. The figures depend on the observed estimate used as a planning reference, which may be an imprecise or optimistic estimate, and they do not reconstruct the original trial design.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 4.690; pooled standard deviation σ = 4.367.
2. n = 2 × (1.96 + 0.842)² × 4.367² / 4.690² = 13.6, rounded up to 14 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 4.69                      # observed difference in means
sigma <- 4.36693987886946                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(559962)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 14 (80% power), 19 (90% power)
 75% of observed effect: n per arm = 25 (80% power), 33 (90% power)
 50% of observed effect: n per arm = 55 (80% power), 73 (90% power)
power.t.test: 14.6 
Simulated power at n = 14 per arm: 0.780 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor-reported analysis for placebo versus AEGR-733 5 mg uses ANOVA and reports a mean difference in final values of 4.68, with a 95% confidence interval from 2.30 to 7.07 and p < 0.001. The simple unadjusted recalculation from the posted arm summaries gives a mean difference of 4.69, with a 95% confidence interval from 2.091 to 7.289 and p < 0.001.

The estimates are close, but the methods and confidence limits are not identical. The registry record does not report enough detail to determine which model specifications or data-handling choices account for the difference. The sponsor's analysis is the registry's reported analysis; the recalculation is a check based on the posted summary statistics and should not replace it. The record marks no discrepancy, and both results report a statistically detectable contrast under their respective analyses.

The sponsor also reports the placebo versus AEGR-733 2.5 mg comparison as 4.92, with a 95% confidence interval from 2.27 to 7.57 and p < 0.001. This is a distinct dose comparison, not a replication of the 5 mg result. Neither reported analysis, by itself, supplies the missing details about multiplicity, missing data, or the prespecified analysis plan.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies the primary endpoint and lists a secondary outcome, but it does not report a complete statistical analysis plan or a multiplicity procedure. The study includes several doses and combination regimens, and the posted results include selected comparisons. When several outcomes, doses, or contrasts are tested, unadjusted p-values do not account for the increased opportunity to observe a nominally small value by chance. The registry record does not state whether any comparisons were prespecified as confirmatory, whether testing was hierarchical, or whether an adjustment was used.

The primary outcome population is labeled ITT, but the record does not provide a detailed definition of that population, the number randomized to each group for the primary outcome, or the participant flow from enrollment through analysis. Outcome denominators differ across the posted arms. Missing-data frequency, reasons for missingness, and the method used to handle missing measurements are not reported in the registry record. This limits assessment of whether the analyzed groups preserve the intended randomized comparison.

The record reports an ANOVA for sponsor analyses and gives arm-level means and standard deviations, but does not fully describe model terms, covariate adjustment, assumptions, or diagnostic checks. It also does not report whether an interim analysis occurred or whether any stopping rule was used. These omissions do not establish that such procedures were absent; they mean that their use is not reported in the registry record. As a result, the posted estimates can be described, but a complete audit of the prespecified inferential strategy is not possible from the registry information.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: chest pain (2.9%), inflammatory bowel disease (2.9%), ankle fracture (2.9%).

The registry reports serious adverse events by arm, with the number at risk and the number affected. The placebo group has 0 of 33 affected; AEGR-733 2.5 mg has 1 of 34; AEGR-733 5 mg has 0 of 34; AEGR-733 7.5 mg has 0 of 34; and AEGR-733 10 mg has 2 of 35. The combination arms report 0 of 28 for AEGR-733 5 mg with atorvastatin, 0 of 33 with fenofibrate, and 0 of 29 with ezetimibe.

These figures are counts of participants affected by serious adverse events as reported in the registry. They do not, on their own, establish whether an event was caused by a study drug, and the record does not provide enough information to assess comparative risk. The registry lists Chest Pain, Inflammatory Bowel Disease, and Ankle Fracture among the top serious event terms, each at 2.9%; it does not specify those term percentages by treatment arm in the available summary. Death counts are not reported in the registry record.

17. What the Result Does, and Does Not, Mean

The posted primary data show a higher mean absolute change from baseline in percent hepatic fat in the AEGR-733 5 mg group than in the placebo group. The recalculated unadjusted mean difference is 4.69, with a 95% confidence interval from 2.091 to 7.289 and p < 0.001. The sponsor-reported ANOVA result is similar in estimated magnitude and also reports p < 0.001. These results describe the measured endpoint and the comparison between the analyzed groups.

They do not establish that AEGR-733 improves health, that the observed change is clinically meaningful, or that a particular direction of change is beneficial. The registry provides no clinical threshold for interpreting the size of the hepatic-fat change. It also does not establish whether the observed difference would persist over a longer period or apply to people outside the study population.

The results do not demonstrate the effects of all doses and combinations simply because those arms were part of the trial. The fullest primary comparison is placebo versus AEGR-733 5 mg. Other arms have descriptive outcome summaries, and only selected comparisons have sponsor-reported analyses. Nor does a small p-value guarantee replication, exclude bias, or resolve the implications of multiple testing and missing data.

In general, randomized comparisons can support estimates of treatment effects when trial conduct and analysis preserve the benefits of randomization. The available registry record confirms randomization and masking designations but does not report every detail needed to assess those conditions. The appropriate conclusion is therefore limited to the posted statistical contrast and its uncertainty, rather than a broad clinical claim.

18. Why This Trial Matters Statistically

This study illustrates why a clinical trial result should be read at several levels. The arm means describe average measured changes; the mean difference summarizes the contrast; the confidence interval conveys uncertainty around that estimate; and the standard deviations show that participant outcomes vary within groups. These measures are related but answer different questions. Looking only at a p-value would omit both the estimated magnitude and the variability around it.

The record also shows how a sponsor analysis and a recalculation from posted summaries can be close without being identical. The sponsor's ANOVA result and the unadjusted recalculation have similar estimates, yet their confidence limits differ. That makes transparent reporting of analysis methods important: readers need to know how the reported estimate was modeled and which population and data were included.

The multiple treatment arms also make multiplicity relevant. A trial with several doses and combinations creates more possible contrasts than a single two-group comparison. Without a reported testing strategy, descriptive patterns and unadjusted secondary findings should not be given the same weight as a clearly prespecified primary analysis.

Finally, the endpoint is a measured biological quantity, while clinical importance requires interpretation beyond statistical significance. The registry provides no threshold for a meaningful change. This distinction helps prevent an apparently clear statistical contrast from being mistaken for evidence about outcomes or benefits that the record does not establish.

19. 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 primary posted comparison covers placebo and AEGR-733 5 mg, while the study included additional dose and combination arms. The record therefore does not support treating the primary comparison as a complete inferential account of every regimen. Although arm-level secondary results are posted, sponsor-reported comparisons are available for only selected contrasts.

The analysis denominators are smaller than the overall enrollment and vary across groups. The registry record does not explain the participant flow, missing outcome data, reasons for missingness, or the method used to address missing measurements. It labels the primary population ITT but does not give further operational details. These gaps limit assessment of the extent to which the analyzed data represent the randomized groups.

The endpoint is a continuous measure of hepatic fat assessed at baseline and 12 weeks on study drug. The record gives no threshold for clinical importance and does not report follow-up beyond the stated timeframe. It is therefore not possible to infer longer-term outcomes or translate the statistical contrast into a clinical benefit.

The registry reports randomization and triple masking but does not describe the randomization procedure, allocation concealment, or which parties were masked. It also does not report the original sample-size justification, a complete statistical analysis plan, or a multiplicity procedure. These matters are not reported in the registry record, so they cannot be evaluated from the posted information. The arm-level standard deviations differ, and the sponsor's ANOVA result is not numerically identical to the summary-statistic recalculation; the available description is insufficient to explain the methodological details behind that difference.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS — NCT00559962.
• Registry record last updated 2018-02-23; status last verified 2018-02.
• Results first posted 2013-02-22.
• 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.

23. Record Summary

NCT00559962 is a completed phase 2 randomized, triple-masked, parallel-group, placebo-controlled study of AEGR-733 in people with hyperlipidemia. The registry reports enrollment of 260 and describes AEGR-733 doses and combination regimens. The primary endpoint is absolute change from baseline in percent hepatic fat, measured by magnetic resonance spectroscopy at baseline and 12 weeks on study drug.

For placebo versus AEGR-733 5 mg, the recalculated unadjusted mean difference is 4.69, with a 95% confidence interval from 2.091 to 7.289 and p < 0.001. The sponsor-reported ANOVA estimate is 4.68, with a 95% confidence interval from 2.30 to 7.07 and p < 0.001. Interpretation is limited by unreported details about multiplicity, missing data, the original design assumptions, and the clinical meaning of the measured change.