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 The Effect of Diflunisal on Familial Amyloidosis (NCT00294671), a randomized phase 2, phase 3 study. The primary outcome is Neurologic Impairment Score + 7 (NIS+7).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00294671 |
| Phase | Phase 2, Phase 3 |
| Condition | Familial Amyloid Polyneuropathy, Familial Amyloidosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 130 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boston University |
| Results posted | Yes |
2. Clinical Question
Population
Participants had familial amyloidosis polyneuropathy, also described in the registry under the conditions familial amyloid polyneuropathy and familial amyloidosis. The trial enrolled 130 participants. The registry says the longitudinal primary-outcome analysis examined data from all 130 using intention-to-treat principles. Further eligibility details, including how the condition was diagnosed and which clinical characteristics were required, are not reported in the registry record.
Intervention
The intervention was diflunisal, described as 250 mg by mouth twice daily. The registry identifies the intervention as a drug. Information about treatment duration, dose changes, adherence, or other medication-management procedures is not reported in the registry record.
Comparator
The comparison group received placebo, described as one tablet by mouth twice daily. The study was randomized, double-masked, and used a parallel-group design. Further details about how the placebo was matched to diflunisal or how masking was maintained are not reported in the registry record.
Primary question
The study asked whether polyneuropathy progression differed between treatment groups, measured with the Neuropathy Impairment Score plus 7 nerve tests (NIS+7). The registry specifies measurements at baseline, 1 and 2 years. It does not report the estimated between-group difference, its confidence interval, or a primary-outcome significance test. The registry’s study purpose refers to preventing progressive lower leg nerve damage; the outcome definition operationalizes progression using the NIS+7 scale.
That distinction matters: the clinical question is about a difference in progression over follow-up, not simply whether either group’s score changed from baseline. A treatment comparison needs an estimate of how the groups’ outcomes differed and how uncertain that estimate is. Those numerical primary results are not reported in the registry record, so the direction, size, and precision of the observed treatment contrast cannot be described from the record. The trial’s recorded design and endpoint clarify what was intended to be compared, but do not establish the result of that comparison.
3. Trial Design
The registry describes a randomized, double-masked, parallel-group trial of diflunisal and placebo. It lists phase 2 and phase 3. Enrollment was 130 participants. The sponsor was Boston University. The trial status is completed; the recorded start is 2006-02 and primary completion is 2012-12. These dates describe the registry record and do not provide additional detail about the timing of individual assessments or the duration of treatment for each participant.
One group received diflunisal 250 mg by mouth twice daily, and the other received placebo one tablet by mouth twice daily. Randomization means assignment was intended to use a chance-based procedure, while a parallel design means participants were assigned to a group rather than switching between study treatments. Double masking indicates that the registry classifies the study as masked at two levels, but the identities of the masked parties and the practical masking procedures are not reported in the registry record. Details of the random sequence, allocation concealment, stratification, and treatment adherence are also not reported in the registry record.
The primary endpoint was assessed at baseline, 1 and 2 years. The registry says the longitudinal analysis examined data from all 130 participants using intention-to-treat principles. This identifies the stated analysis population and general approach, but does not specify the statistical model, how incomplete follow-up was handled, or whether every participant contributed observations at every time point. Those analysis details are not reported in the registry record.
The registry lists four secondary outcome types: the Kumamoto Neurologic Scale, modified Body Mass Index (mBMI), and the physical and mental component scores of the SF-36 quality-of-life questionnaire. It also records 5 outcome measures and 10 analyses. The definitions, time points, and analysis methods for each of these measures are not fully described in the record. Further information about protocol procedures, prespecified analysis decisions, and any changes made during the study is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: All enrolled participants were randomized to treatment groups.
Overall Study
| Stage | Diflunisal | Placebo |
|---|---|---|
| STARTED | 64 | 66 |
| COMPLETED | 37 | 26 |
| NOT COMPLETED | 27 | 40 |
Reasons for not completing this period:
| Reason | Diflunisal | Placebo |
|---|---|---|
| Lack of Efficacy | 11 | 23 |
| Liver transplant | 7 | 9 |
| Drug related adverse event (AE) | 4 | 2 |
| Non-drug related AE | 3 | 2 |
| Lost to Follow-up | 1 | 3 |
| Non-compliance | 1 | 0 |
| Death | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Longitudinal analysis examined data from all 130 participants using intention-to-treat principles.
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 | Diflunisal | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 64 | 66 | 130 | |
| Age, Continuous | years | 60.3 (SD 11.7) | 59.2 (SD 12.2) | 59.7 (SD 11.9) |
| Sex: Female, Male: Female | Participants | 21 | 22 | 43 |
| Sex: Female, Male: Male | Participants | 43 | 44 | 87 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 8 | 6 | 14 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 5 | 6 |
| Race (NIH/OMB): White | Participants | 52 | 50 | 102 |
| Race (NIH/OMB): More than one race | Participants | 3 | 4 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 34 | 35 | 69 |
| Region of Enrollment: United Kingdom | participants | 3 | 4 | 7 |
| Region of Enrollment: Italy | participants | 10 | 11 | 21 |
| Region of Enrollment: Japan | participants | 5 | 4 | 9 |
| Region of Enrollment: Sweden | participants | 12 | 12 | 24 |
| NIS+7 score | units on a scale | 51.6 (SD 42.8) | 59.0 (SD 50) | 55.3 (SD 46.5) |
| Kumamoto score | units on a scale | 15.3 (SD 10.8) | 16.7 (SD 13.5) | 16.0 (SD 12.2) |
| Modified BMI | kg/M2 x g/L | 1024.4 (SD 226.3) | 1019 (SD 255) | 1021.7 (SD 240.4) |
| SF-36 physical component score | units on a scale | 35.9 (SD 11.6) | 34.8 (SD 11) | 35.4 (SD 11.3) |
| SF-36 mental component score | units on a scale | 46.6 (SD 14.1) | 46.5 (SD 11.8) | 46.6 (SD 12.9) |
6. Primary Endpoint
The registry lists the primary outcome as Neurologic Impairment Score + 7 (NIS+7), measured over Baseline, 1 and 2 years.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the Neurologic Impairment Score plus 7 nerve tests, abbreviated NIS+7. The registry describes it as a measure of polyneuropathy progression and gives its scale range as 0 to 270 points. A score of 0 represents no neurologic deficits; 270 represents no detectable peripheral nerve function. The scale therefore represents neurological impairment, with higher values corresponding to greater impairment as described by those endpoints.
The endpoint combines a neurologic impairment score with 7 nerve tests. The registry does not give further detail about the component tests, scoring procedure, or how the combined measure is calculated. It states that the primary endpoint was the difference in progression between treatments, with assessments at baseline, 1 and 2 years. Repeated measurements can describe the course of a condition over time and allow a comparison of the groups’ trajectories, rather than relying only on a single measurement.
As general statistical context, a continuous score can capture gradations of impairment rather than reducing outcomes to a yes-or-no category. That can make it useful for studying changes across follow-up, provided the scale is measured consistently and the analysis appropriately accounts for repeated observations. The registry identifies the measure and its intended role, but it does not report the primary outcome estimates or the analysis model. Therefore, the posted record does not establish the observed size or precision of the between-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry makes the trial’s central comparison identifiable: diflunisal versus placebo, with NIS+7 used to assess polyneuropathy progression at baseline, 1 and 2 years. It also states that the primary analysis followed intention-to-treat principles and examined data from all 130 participants. However, it does not report the numerical primary outcome results. In particular, the registry record does not report the group estimates, the between-group contrast, a confidence interval for that contrast, or a p-value for the primary comparison. Without those results, the direction and magnitude of the observed difference cannot be evaluated.
The endpoint description alone is not an outcome finding. The scale’s range and interpretation explain what NIS+7 is intended to measure, but they do not show how participants’ scores changed or whether the groups differed. Nor does the completed status supply the missing treatment-effect estimate. Completion indicates the recorded status of the study, not whether a particular result was statistically persuasive or clinically important.
The registry lists secondary outcomes involving neurologic function, body mass index, and quality of life. It does not provide the numerical results for these measures in the information recorded. It records 5 outcome measures and 10 analyses, but does not give enough detail to determine which analysis corresponds to each listed measure or how the results were selected and interpreted. Those missing details prevent a full assessment of the breadth of reported findings.
The record does include adverse-event counts. Serious adverse events affected 3 participants among 64 at risk in the diflunisal group and 4 among 66 at risk in the placebo group. Other adverse events are recorded as affecting 29 among 64 at risk in the diflunisal group and 27 among 66 at risk in the placebo group. These counts are descriptive registry entries. The record does not provide the event-level detail, exposure-adjusted rates, or statistical comparisons needed to interpret differences in risk. Death counts are not reported in the registry record.
As general statistical context, an estimate and its uncertainty are both needed to judge how compatible the observed data are with a range of possible effects. A confidence interval expresses uncertainty around an estimate; a narrow interval is more precise than a wide interval, while neither by itself determines whether an effect is clinically important. Since the primary estimate and interval are not reported, no such precision assessment can be made for the principal treatment comparison from the registry record.
9. Statistical Methods Explained
What does a mean represent for this endpoint?
The registry identifies the primary outcome as a mean of a continuous measure. As general statistical context, a mean describes the average value in a group, but it does not show the range of individual participant outcomes. Two groups can have similar means while having different distributions, and a mean can be affected by unusually high or low observations. For a repeated measure such as NIS+7, analysis also needs to reflect that measurements from the same participant are related over time. The registry does not report the model used to estimate the means or the treatment contrast.
What does a confidence interval communicate?
The registry specifies 95% confidence intervals as the dispersion format for the primary outcome. As general statistical context, a confidence interval gives a range of values compatible with the data and the method used to estimate the effect. It communicates precision as well as the estimated effect’s direction and scale. A confidence interval is not a guarantee that the true value lies within the particular interval, and it does not establish clinical importance on its own. The numerical interval for the primary contrast is not reported in the registry record, so its width and the values it includes cannot be assessed.
Why analyze measurements over time?
The primary outcome timeframe is baseline, 1 and 2 years. As general statistical context, longitudinal analysis can use the sequence of observations to compare outcome patterns across groups. It can account for the fact that repeated scores from one participant are not independent observations. Choices about the model, covariance structure, baseline adjustment, and handling of measurements that are not observed can influence estimates and uncertainty. Those specific choices are not reported in the registry record. The record’s statement that the analysis was longitudinal describes the broad approach, not its full specification.
What does intention-to-treat indicate?
The registry says data from all 130 participants were examined using intention-to-treat principles. As general statistical context, intention-to-treat analysis generally seeks to retain participants in the groups to which they were randomized, even if treatment adherence or subsequent care differs from assignment. It supports interpreting the contrast as one based on randomized assignment. The label does not, by itself, explain how missing outcome measurements were handled, whether all randomized participants contributed to every analysis, or what assumptions were made for incomplete data. Those particulars are not reported in the registry record.
How should the planning illustrations be understood?
The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was originally designed using those calculations. The record explicitly distinguishes the illustrations from the trial’s own design. The underlying observed effect and the numerical planning illustrations are not reported in the registry record.
As general statistical context, sample-size planning asks how many participants per arm would be needed under specified assumptions to detect an effect with a chosen probability, if those assumptions hold. An illustration based on an observed effect is especially dependent on the estimate used: an uncertain observed effect can yield an uncertain planning estimate. Such calculations do not describe the probability that the completed trial’s result is true, and they are not observed power. They should not be treated as a substitute for the reported treatment-effect estimate and confidence interval.
Why can variability matter?
As general statistical context, variability reflects how spread out participant outcomes are around a group summary. Greater variability usually makes a group mean less precise when other features are held constant. If data are more dispersed than an analysis assumes, uncertainty estimates based on that assumption can be too small. The registry identifies a continuous primary measure and confidence intervals but does not report distributional checks, the observed variability, or any adjustment for departures from model assumptions. No conclusion about those features can be drawn from the record.
The registry records 10 analyses, but does not describe all of their specifications or how each relates to the primary and secondary measures. Multiple analyses can raise questions about selective reporting and multiplicity. As general statistical context, multiplicity refers to the increased chance of at least one apparently notable finding when many hypotheses are tested. Whether and how to address that issue depends on the prespecified analysis plan and the role of each comparison; those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed at baseline, 1 and 2 years, and the registry describes the endpoint as a difference in progression between treatments. Multiple time points can raise questions about which contrast is primary, whether the analysis evaluates change over time or a specific visit, and how repeated observations are incorporated. The registry does not report a single numerical primary comparison or the full analysis specification. It notes that the primary outcome has several categories or time points and is not reduced to one comparison, so a single comparison should not be inferred from the record.
The record lists four types of secondary outcomes and records 5 outcome measures and 10 analyses. When several outcomes or analyses are considered, multiplicity can make an isolated small p-value less persuasive unless the analysis plan accounts for the number and purpose of the comparisons. As general statistical context, possible approaches include defining a hierarchy of outcomes or adjusting inference for multiple tests. The registry record does not report whether any multiplicity adjustment or hierarchy was prespecified, nor does it provide enough analysis detail to assess selective reporting.
The registry states that longitudinal analysis examined data from all 130 participants using intention-to-treat principles. This does not establish that every scheduled measurement was available for every participant. The handling of missed visits, withdrawals, incomplete questionnaires, or other missing observations is not reported in the registry record. Nor are the reasons for missing data, the amount of missingness at each time point, or any sensitivity analyses described. As general statistical context, missing-data assumptions matter because results can depend on whether unobserved outcomes resemble observed outcomes after accounting for available information. The registry’s broad analysis label does not reveal which assumptions or methods were used.
Additional details about analysis populations, protocol deviations, and any changes to prespecified outcomes are not reported in the registry record. These omissions limit independent assessment of how consistently the reported analyses followed the intended plan.
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 |
|---|---|---|---|
| Diflunisal | 3 | 64 | 4.7% |
| Placebo | 4 | 66 | 6.1% |
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 |
|---|---|
| Diflunisal | 29 of 64 |
| Placebo | 27 of 66 |
Most frequent serious adverse event terms
| Event term | Organ system | Diflunisal | Placebo |
|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | 1 of 64 | 2 of 66 |
| Cardiac disorders | Cardiac disorders | 2 of 64 | 1 of 66 |
| Renal and urinary disorders | Renal and urinary disorders | 0 of 64 | 2 of 66 |
| Infections and infestations | Infections and infestations | 0 of 64 | 1 of 66 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 1 of 64 | 0 of 66 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Diflunisal | Placebo |
|---|---|---|---|
| Infections | Infections and infestations | 24 of 64 | 27 of 66 |
| GI disorders | Gastrointestinal disorders | 23 of 64 | 25 of 66 |
| Nervous system disorders | Nervous system disorders | 23 of 64 | 20 of 66 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | 19 of 64 | 8 of 66 |
| General disorders | General disorders | 19 of 64 | 7 of 66 |
| Cardiac disorders | Cardiac disorders | 15 of 64 | 9 of 66 |
| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | 12 of 64 | 11 of 66 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 13 of 64 | 9 of 66 |
| Investigations | Investigations | 11 of 64 | 11 of 66 |
| Renal and urinary disorders | Renal and urinary disorders | 10 of 64 | 12 of 66 |
Serious events with the highest arm-level rate: cardiac disorders (3.1%), gastrointestinal disorders (3.0%), renal and urinary disorders (3.0%), injury, poisoning and procedural complications (1.6%), infections and infestations (1.5%).
For serious adverse events, the registry records 3 affected among 64 at risk in the diflunisal group and 4 among 66 at risk in the placebo group. For other adverse events, it records 29 affected among 64 at risk in the diflunisal group and 27 among 66 at risk in the placebo group. These are participant counts, not a complete description of event timing, severity beyond the serious/non-serious distinction, recurrence, or duration. The record does not give a statistical comparison of the groups for these counts.
The registry also lists serious-event terms with percentages: cardiac disorders, 3.1%; gastrointestinal disorders, 3.0%; renal and urinary disorders, 3.0%; injury, poisoning and procedural complications, 1.6%; and infections and infestations, 1.5%. The record does not specify in this listing how the percentages were calculated or provide a treatment-group breakdown for each term. They should not be read as group-specific risks without that information.
As general statistical context, adverse-event counts can be difficult to compare when time at risk, event definitions, or reporting practices differ. The registry does not report exposure-adjusted analyses or enough detail to determine whether an individual could contribute more than one event. Death counts are not reported in the registry record. These safety entries describe recorded events; they do not, on their own, establish a causal relationship to study treatment.
12. What the Result Does, and Does Not, Mean
The registry identifies a randomized comparison of diflunisal and placebo and specifies a neurological outcome intended to measure polyneuropathy progression. It also describes a longitudinal analysis using intention-to-treat principles and gives adverse-event counts. These details establish the broad question and the types of information recorded. They do not supply the numerical primary treatment effect.
Because the registry record does not report the NIS+7 group results, between-group estimate, confidence interval, or primary-outcome test, it is not possible to state whether the posted primary results favored either group, how large any difference was, or how precise it was. The completed status and trial purpose cannot fill that gap. The absence of numerical results in the registry record should not be interpreted as evidence of no effect, nor as evidence of an effect.
Even when an estimate is available, statistical evidence and clinical importance are different questions. As general statistical context, an estimate describes the observed contrast, while uncertainty describes how much the data leave unresolved. Clinical importance requires context about what magnitude of change would matter to participants and clinicians. The registry does not report a threshold for a meaningful NIS+7 difference, and without an effect estimate there is no observed contrast to compare with such a threshold.
The adverse-event entries also have limits. They report counts in the two groups, but the record does not include detailed event-level information, exposure-adjusted comparisons, or a statistical assessment of the difference. Those counts can describe what was recorded, but they should not be treated as a definitive comparison of safety or as proof that any event was caused by treatment.
The most defensible reading is therefore narrow: the registry describes the trial’s design, treatment groups, planned primary measure, and some adverse-event counts, while leaving the main numerical efficacy results and several analysis details unreported. Any conclusion about the size, direction, precision, or clinical meaning of the primary treatment difference would require results not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly defined endpoint and a reported treatment contrast are both necessary for statistical interpretation. The registry identifies NIS+7, describes the scale’s endpoints, and gives the assessment timeframe. That information lets readers understand what the primary outcome was intended to capture. But without the estimated difference and its uncertainty, readers cannot assess the observed pattern of progression or distinguish a precise estimate from a highly uncertain one.
The design features also shape how evidence should be read. Randomization and double masking identify important design intentions, while the parallel-group structure clarifies that the two groups were compared over time. The registry’s intention-to-treat statement identifies a broad analysis principle. Yet each label leaves important implementation questions unanswered, including the randomization procedure, the handling of missing measurements, and the model used for repeated outcomes. Statistical interpretation depends on both the stated design and the detail of how it was carried out.
Recording multiple outcomes and analyses also makes transparency important. The registry lists several secondary measures and records 10 analyses, but does not report the full analysis plan or how multiplicity was handled. Those details help readers distinguish prespecified primary tests from exploratory comparisons and assess how much weight to give individual findings.
Finally, the safety entries show why event counts need context. A count without exposure time, event-level information, or a comparative analysis is useful as a descriptive record but limited as a basis for comparing risks. Taken together, the record demonstrates that trial design information and outcome results answer different questions. Design describes how evidence was intended to be generated; numerical estimates, uncertainty, and analysis details are needed to judge what the evidence shows.
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 principal limitation for interpreting this trial from the registry record is that the numerical primary outcome results are not reported. The record does not give the group means, the between-group difference, a confidence interval, or a primary-outcome test. As a result, the direction, size, and precision of the primary comparison cannot be assessed. The registry’s outcome description and completed status do not substitute for those results.
The record specifies assessment at baseline, 1 and 2 years but does not describe the statistical model used for the longitudinal analysis. It does not report the handling of incomplete observations, the amount or pattern of missing data, or sensitivity analyses. Although the analysis is described as using intention-to-treat principles and all 130 participants, the record does not clarify whether all participants contributed data at each time point.
Important trial-procedure details are also not reported in the registry record. These include the randomization method, allocation concealment, masking procedures, treatment adherence, and relevant eligibility criteria. The record lists several secondary outcomes and 10 analyses, but does not provide a complete analysis plan or say whether multiplicity was addressed. This limits assessment of how prespecified comparisons relate to the analyses recorded.
For safety, the registry gives counts and a list of serious-event terms with percentages, but does not provide event-level descriptions, time at risk, exposure-adjusted comparisons, or death counts. The basis for the listed percentages and their relationship to treatment groups is not specified. These limitations restrict interpretation of both outcome and safety information to the details explicitly recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effect of Diflunisal on Familial Amyloidosis — NCT00294671.
- Registry record last updated 2017-03-17; status last verified 2017-01.
- Results first posted 2017-03-17.
- 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.
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
NCT00294671 is a completed randomized, double-masked, parallel-group trial listed as phase 2 and phase 3. It enrolled 130 participants and compared diflunisal 250 mg by mouth twice daily with placebo one tablet by mouth twice daily. The registry records a start of 2006-02 and primary completion of 2012-12, with Boston University as sponsor.
The primary endpoint was NIS+7, assessed at baseline, 1 and 2 years, to measure polyneuropathy progression. The registry says the longitudinal analysis used intention-to-treat principles and examined data from all 130 participants. It lists secondary measures involving the Kumamoto Neurologic Scale, modified Body Mass Index, and SF-36 physical and mental component scores.
Numerical primary outcome results and key analysis details are not reported in the registry record. Serious adverse events affected 3 among 64 at risk in the diflunisal group and 4 among 66 at risk in the placebo group; other adverse events affected 29 among 64 and 27 among 66, respectively. Death counts are not reported in the registry record.