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 Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate (NCT01568112), a randomized phase 3 study. The primary outcome is Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01568112 |
| Phase | Phase 3 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 173 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Biogen |
| Results posted | Yes |
2. Clinical Question
Population
Healthy volunteers who received study medication were the population of interest. For the primary outcome, the defined population included participants who received at least 1 dose and had at least 1 relevant diary entry during the visit interval. The registry record does not report how many participants met that endpoint-specific definition.
Intervention
The study evaluated BG00012, also called dimethyl fumarate, with either aspirin pretreatment or a slow-titration schedule. In the aspirin group, participants received BG00012 for 8 weeks, starting at 120 mg BID during the first week and then receiving 240 mg BID during the subsequent 7 weeks; aspirin pretreatment was given during the first 4 weeks. In the slow-titration group, the BG00012 dose increased over the first 4 weeks before continuing at 240 mg BID during Weeks 5 to 8.
Comparator
The study also included a BG00012 group without aspirin pretreatment and a placebo group. Participants in the BG00012 group received ASA placebo during the first 4 weeks. Participants in the placebo group received BG00012 placebo for 8 weeks and ASA placebo during the first 4 weeks. The registry record describes these groups but does not report the primary outcome values by group.
Primary question
The primary objective was to evaluate whether aspirin pretreatment or slow titration changed the incidence and severity of flushing and gastrointestinal events following BG00012 administration. The registered primary endpoint was the percentage of participants reporting overall flushing events during Day 1 to Week 8, assessed with the Modified Flushing Severity Scale. The registry record does not report a numerical result or a group comparison for this endpoint, so the size and precision of any difference cannot be described from the posted record.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group phase 3 study, described in its official title as phase 3b. The registry lists an enrollment of 173 and identifies the participants as healthy. Biogen is listed as the sponsor. The study is marked completed, with a start date of 2012-04 and primary completion in 2012-10. These registry entries describe the trial’s setting and design, but do not give results for the primary endpoint.
The four arm descriptions distinguish BG00012 with and without aspirin pretreatment, BG00012 given on a slow-titration schedule, and BG00012 placebo. The standard BG00012 schedule began at 120 mg BID during the first week and continued at 240 mg BID for the subsequent 7 weeks. Aspirin pretreatment was given during the first 4 weeks in the BG00012 + ASA group. The slow-titration schedule used 120 mg once daily during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4 and Weeks 5 to 8. The registry describes ASA as a 325 mg microcoated tablet in the study objective.
The primary endpoint covered the overall treatment period, Day 1 to Week 8. Its analysis population was defined using medication exposure and availability of at least 1 relevant diary entry during the visit interval. This definition matters because the endpoint population may not be identical to everyone enrolled. The number who met the endpoint-specific definition is not reported in the registry record. Arm-specific numbers randomized, withdrawals, and completion counts are also not reported in the registry record.
The registry lists 28 outcome measures and 162 analyses, including safety, laboratory, vital-sign, ECG, and flushing measures. The detailed statistical plan, including the planned primary comparison and how the multiple analyses were to be handled, is not reported in the registry record. The record therefore supports a description of the trial structure and dosing schedules, but not a reconstruction of its full analysis plan.
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 | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration |
|---|---|---|---|---|
| STARTED | 44 | 44 | 43 | 42 |
| COMPLETED | 39 | 36 | 36 | 30 |
| NOT COMPLETED | 5 | 8 | 7 | 12 |
Reasons for not completing this period:
| Reason | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration |
|---|---|---|---|---|
| Randomized But Not Treated | 0 | 1 | 0 | 0 |
| Withdrew due to Adverse Event | 2 | 4 | 6 | 3 |
| Lost to Follow-up | 0 | 0 | 0 | 1 |
| Withdrawal by Subject | 2 | 3 | 0 | 7 |
| Withdrawal by Physician | 1 | 0 | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
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: All randomized and treated participants
| Characteristic | Unit | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 44 | 43 | 43 | 42 | 172 | |
| Age, Continuous | years | 35.5 (SD 8.78) | 39.0 (SD 9.61) | 38.1 (SD 10.29) | 36.2 (SD 9.33) | 37.2 (SD 9.54) |
| Age, Customized: 25 to 34 years | participants | 22 | 19 | 17 | 21 | 79 |
| Age, Customized: 35 to 44 years | participants | 13 | 7 | 13 | 10 | 43 |
| Age, Customized: 45 to 55 years | participants | 9 | 17 | 13 | 11 | 50 |
| Sex: Female, Male: Female | Participants | 14 | 21 | 17 | 20 | 72 |
| Sex: Female, Male: Male | Participants | 30 | 22 | 26 | 22 | 100 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS), measured over Day 1 to Week 8.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants reporting overall flushing events during the overall treatment period, assessed by the Modified Flushing Severity Scale (MFSS). The timeframe was Day 1 to Week 8. A participant-reported endpoint captures symptoms as experienced by participants rather than relying only on clinical observation or a laboratory measure. Flushing was defined in the registry as redness, warmth, tingling, or itching of the skin.
The MFSS questionnaire asked about flushing-related side effects since administration of the investigational drug. Participants were to complete it in an electronic diary within 10 hours of taking study medication, 2 times/day. Each question was rated on a scale from 0, meaning no flushing side effects, to 10, meaning extreme flushing side effects. The endpoint concerns the percentage of participants reporting an overall flushing event; the registry description also indicates that the scale assessed severity. These are related but distinct aspects: the percentage addresses how many participants reported an event, while a severity rating describes the reported experience.
The primary analysis population was limited to participants who received at least 1 dose and had at least 1 relevant diary entry during the visit interval. That rule identifies who could contribute to this endpoint, but the registry record does not report the number included in each group, the handling of incomplete diary data, or the group-specific endpoint results. The endpoint was relevant to the study objective because the trial sought to evaluate flushing during BG00012 treatment, including whether aspirin pretreatment or gradual dose escalation changed the reported experience. No conclusion about those comparisons can be drawn from the endpoint description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the clinical question and endpoint definition, but it does not report the primary outcome result. In particular, it does not give the percentage of participants reporting flushing in each group, an estimated difference between groups, a confidence interval, or a p-value for the primary comparison. Without those quantities, the observed direction, magnitude, and statistical precision of the primary result cannot be characterized. The record also does not give a numerical result for the gastrointestinal component of the study objective.
The endpoint was participant-reported and depended on diary completion. The record defines the endpoint population as participants who received at least 1 dose and had at least 1 relevant diary entry. This is important when interpreting any percentage: it describes the participants included in that endpoint analysis, not necessarily everyone enrolled. The number meeting the definition and the number with missing diary observations are not reported in the registry record, so the completeness of endpoint follow-up cannot be assessed from the available registry entries.
The trial included different treatment schedules, not just a single active-treatment group and a single comparator. BG00012 was evaluated with ASA pretreatment, without ASA pretreatment, and with slow titration, alongside a placebo group. A valid interpretation would need to identify which pairwise or other comparisons were planned and how the endpoint was summarized. Those details, as well as the actual comparison estimates, are not reported in the registry record. The treatment descriptions alone do not show whether any group differed on flushing.
Some safety counts are reported separately. Serious AEs affected 0 of 44 participants in the placebo group, 1 of 43 in the BG00012 group, 0 of 43 in the BG00012 + ASA group, and 0 of 42 in the BG00012 Slow Titration group. Other AEs affected 5 of 44, 12 of 43, 15 of 43, and 12 of 42 participants in those respective groups. These are descriptive participant counts, not a substitute for the missing primary endpoint results. The registry does not provide confidence intervals or comparative tests for these safety figures.
General statistical interpretation: a confidence interval expresses the uncertainty around an estimate under a specified analysis. Its width depends on the amount of information and the variability in the data. Without the primary estimates and confidence intervals, readers cannot judge how precisely the trial estimated the flushing outcome or whether the data are compatible with a range of clinically relevant differences. A missing p-value also does not establish that groups were alike; the registry record simply does not report the inferential result.
9. Statistical Methods Explained
The registry describes a randomized, masked, parallel-group trial and identifies a participant-level percentage as the primary outcome. It does not report the statistical method used to compare groups for that outcome. The explanations below are general statistical context, not a description of an unreported analysis plan.
What does a percentage endpoint represent?
For an outcome defined as the percentage of participants reporting an event, each participant is classified according to whether the event was reported under the endpoint definition. The percentage is a summary of the fraction of analyzed participants with the event. It is different from a count of all symptom episodes: a participant with repeated reports may still contribute as one participant to a participant-level event percentage, depending on the prespecified definition. The registry identifies the primary measure as the percentage of participants reporting overall flushing events, but the detailed event-counting rules and group-specific values are not reported in the registry record.
When comparing groups, an analysis may describe each group’s percentage and estimate a difference between them, or use another contrast chosen in the analysis plan. The exact contrast matters because the study contains multiple active schedules and a placebo group. The planned primary comparison, any adjustment for baseline or other factors, and the method used to calculate uncertainty are not reported in the registry record. It would therefore be inappropriate to attribute a particular statistical test or model to this trial.
How should uncertainty be read?
General explanation: a confidence interval is a range of estimates compatible with the observed data under the assumptions of a statistical procedure. It communicates precision as well as direction and magnitude. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on different sides of a null contrast may leave the direction uncertain. An interval is not a guarantee that the true value lies inside it, and it does not by itself establish clinical importance. The registry record does not report a confidence interval for the primary endpoint.
A p-value, when reported, describes how unusual the observed data or more extreme data would be under a specified null hypothesis and analysis. It does not measure the probability that the null hypothesis is true, nor does it measure the size or importance of a difference. The primary endpoint p-value and the hypotheses used for the analysis are not reported in the registry record. A reader should not infer a positive or negative finding from the existence of a registered objective or from the trial’s completed status.
What role does the diary population play?
The registry’s endpoint population required at least 1 dose of study medication and at least 1 diary entry of the relevant questionnaire data during the visit interval. That requirement creates a defined analysis population for the participant-reported endpoint. It does not, on its own, describe how participants with partial diary completion were handled, whether repeated entries were summarized in a particular way, or whether missing entries were imputed. Those details are not reported in the registry record. General statistical principle: missing outcome data can affect both the number of participants contributing information and the interpretation of a group comparison, especially when missingness differs across groups or is related to symptoms.
Because flushing was recorded in an electronic diary within 10 hours of medication administration, timing and completeness of entries are relevant to measurement. The instructions specified completion 2 times/day, but the record does not report diary adherence, the number of completed entries, or validation rules for late or absent entries. No assumption about those matters can be made from the endpoint description.
What do the planning illustrations mean?
The record’s planning assumptions describe illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. For time-to-event outcomes, the stated planning quantity is total events; for other outcomes, it is participants per arm. These are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions. The numerical illustration values are not reported in the registry record, and the trial’s own sample-size justification is not reported in the registry record.
General explanation: a sample-size calculation asks how much information a planned study might need to detect a specified effect under chosen assumptions. Its result depends on the outcome, comparison, variability or event frequency, allocation, and desired operating characteristics. A calculation made after results are known, using an observed effect as its starting point, is not a prospective design justification and should not be interpreted as proof that the study had adequate power. The registry’s planning assumptions explicitly identify their purpose as an illustration rather than the trial’s own design.
Why do multiple analyses matter?
The registry lists 28 outcome measures and 162 analyses. General statistical principle: when many outcomes or comparisons are examined, the chance of obtaining apparently notable results by chance can increase if each is interpreted without regard to the others. Analysis plans may address this through a hierarchy of outcomes, adjustment procedures, or a distinction between confirmatory and exploratory analyses. Which approach, if any, was used in this trial is not reported in the registry record. The count of registered analyses alone does not establish that a particular multiplicity adjustment was or was not applied.
For binary participant-level endpoints, sample size and precision are influenced by the number of participants contributing data and by the frequency of the event. General explanation: sparse events can make estimates less precise and can limit the usefulness of some model-based methods. This principle is relevant to interpreting event outcomes in general, but the primary flushing event counts and statistical estimates are not reported in the registry record, so no specific claim about sparsity or model suitability can be made for that endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and 162 analyses, spanning flushing, duration of flushing, adverse events, laboratory shifts, vital signs, and ECG results. Having multiple outcomes and analyses raises a general interpretive issue: a collection of tests does not have the same error properties as a single prespecified test if every result is treated as independently confirmatory. The registry record does not report a multiplicity strategy, a hierarchy of endpoints, or which analyses were designated confirmatory versus exploratory. The number of analyses alone does not show how the investigators interpreted or adjusted them.
The primary endpoint population required participants to have received at least 1 dose and to have at least 1 relevant diary entry during the visit interval. The registry does not report the number meeting that criterion by group, the extent or pattern of missing diary data, or how incomplete questionnaires were handled. It also does not report whether an imputation method, sensitivity analysis, or other missing-data procedure was used. Consequently, the endpoint definition can be described, but the effect of missing diary information on the analysis cannot be assessed.
The record does not report the full analysis populations, such as the numbers included in each efficacy analysis or whether analyses followed randomized assignment. Arm-specific randomized counts, withdrawals, and exclusions are not reported in the registry record. These omissions limit assessment of whether the analyzed groups remained comparable and how the endpoint population related to total enrollment.
The registry also does not report the primary comparison’s statistical model, adjustment variables, confidence interval method, or inferential result. It is not appropriate to assume a conventional analysis plan from the randomized design or from the endpoint type. The available record supports only the stated endpoint definition and the reported design features; multiplicity handling, missing-data methods, and detailed analysis-population rules remain unreported.
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 |
|---|---|---|---|
| Placebo | 0 | 44 | 0.0% |
| BG00012 | 1 | 43 | 2.3% |
| BG00012 + ASA | 0 | 43 | 0.0% |
| BG00012 Slow Titration | 0 | 42 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 5 of 44 |
| BG00012 | 12 of 43 |
| BG00012 + ASA | 15 of 43 |
| BG00012 Slow Titration | 12 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration |
|---|---|---|---|---|---|
| Ovarian germ cell teratoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 44 | 1 of 43 | 0 of 43 | 0 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | BG00012 | BG00012 + ASA | BG00012 Slow Titration |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 4 of 44 | 9 of 43 | 2 of 43 | 9 of 42 |
| Upper respiratory tract infection | Infections and infestations | 1 of 44 | 3 of 43 | 7 of 43 | 1 of 42 |
| Diarrhoea | Gastrointestinal disorders | 0 of 44 | 2 of 43 | 5 of 43 | 0 of 42 |
| Eosinophilia | Blood and lymphatic system disorders | 0 of 44 | 1 of 43 | 3 of 43 | 2 of 42 |
| Vomiting | Gastrointestinal disorders | 0 of 44 | 2 of 43 | 3 of 43 | 0 of 42 |
| Abdominal pain | Gastrointestinal disorders | 0 of 44 | 0 of 43 | 3 of 43 | 0 of 42 |
Serious events with the highest arm-level rate: ovarian germ cell teratoma stage i (2.3%).
The registry reports serious AE counts by group. The placebo group had 0 of 44 participants affected, the BG00012 group had 1 of 43, the BG00012 + ASA group had 0 of 43, and the BG00012 Slow Titration group had 0 of 42. These are participant counts within the listed safety groups. They describe the reported serious AE experience in those groups, but do not establish that the groups differ. Comparative estimates, confidence intervals, and statistical tests for these counts are not reported in the registry record.
The separate other-AE counts were 5 of 44 in the placebo group, 12 of 43 in the BG00012 group, 15 of 43 in the BG00012 + ASA group, and 12 of 42 in the BG00012 Slow Titration group. These counts should not be combined with the serious AE counts: they are presented as a distinct category in the registry record. The record also lists “Ovarian germ cell teratoma stage I” as a serious term with 2.3%; the context and denominator for that term are not reported in the registry record.
Death counts are not reported in the registry record. The small safety-group counts and the absence of comparative uncertainty estimates limit what can be concluded from these descriptive figures. They should be read as recorded participant counts, not as a complete assessment of relative safety.
12. What the Result Does, and Does Not, Mean
The study was designed to evaluate flushing and gastrointestinal events among healthy volunteers receiving BG00012, including comparisons involving aspirin pretreatment and slow titration. The registry specifies a participant-reported primary endpoint for overall flushing during Day 1 to Week 8. It also describes the dosing schedules and reports selected safety counts. These details explain the question the trial addressed and how the primary symptom measure was intended to be collected.
The posted record does not report the primary endpoint values by group or a statistical comparison. It therefore does not establish whether flushing was more or less frequently reported in any group, how large a group difference may have been, or how precisely such a difference was estimated. The absence of a reported comparison is not evidence that groups were the same. The record likewise does not provide a numerical primary result for gastrointestinal events, despite including them in the study objective.
The safety counts show that serious AEs were reported in one participant in the BG00012 group and none in the other listed groups, while other AE counts were also reported for each group. Those figures are descriptive and do not answer the primary flushing question. They should not be treated as proof of a difference or absence of a difference in safety, particularly because comparative estimates and uncertainty intervals are not reported.
The findings described in the registry concern healthy volunteers and the treatment schedules used in this study. The record does not support extrapolation beyond that study population or provide a basis for advice about treatment. In statistical terms, the central limitation is not merely that the estimate may be imprecise: the primary estimate itself is not reported. Readers can identify the study design, endpoint, and some safety counts, but cannot evaluate the primary treatment comparison from the registry record.
More complete interpretation would require group-specific primary outcome results, the analysis population and missing-data handling, and the planned comparison with its uncertainty estimate. The registry record does not report those details. Until they are available, the study objective should be distinguished from evidence about the outcome: an objective states what a trial set out to evaluate, while a reported result is needed to describe what the data showed.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and analysis populations matter for participant-reported outcomes. Flushing was assessed with an electronic diary and the MFSS, with entries intended within 10 hours of taking study medication and 2 times/day. The primary endpoint was not simply a general judgment about tolerability: it was defined as the percentage of participants reporting overall flushing events during a specified treatment period. The endpoint population also required medication exposure and at least 1 relevant diary entry.
The trial’s parallel groups separate several questions that can otherwise be conflated: BG00012 with aspirin pretreatment, BG00012 without aspirin pretreatment, BG00012 with gradual dose escalation, and placebo. Each schedule represents a distinct comparison, and the selected comparator affects the interpretation of an estimate. Without the registered analysis details and group-specific primary results, the design cannot be translated into a conclusion about any one contrast.
The record also demonstrates that the presence of many listed outcomes and analyses has statistical implications. With 28 outcome measures and 162 analyses, readers need to know which comparisons were primary and how additional analyses were interpreted. Those methods are not reported in the registry record. This is a reminder that an endpoint list is not a substitute for a prespecified analysis plan or a transparent account of multiplicity handling.
Finally, descriptive safety counts and an incomplete primary outcome record serve different purposes. Safety counts can provide a limited description of reported events, while the primary endpoint requires its own estimates and uncertainty. A study’s completion status, sample size, and detailed protocol objectives do not reveal the unreported primary results. For statistical readers, separating design information from results is essential to avoid treating the existence of a trial question as evidence of its answer.
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 the absence of numerical primary outcome results. Group-specific flushing percentages, a treatment contrast, confidence intervals, and a p-value are not reported. The registry record also does not report a numerical result for gastrointestinal events. As a result, neither the direction nor the precision of the primary comparisons can be evaluated.
The endpoint relied on participant diaries, but diary completion and missingness are not described beyond the minimum requirement of at least 1 relevant entry. Numbers meeting the endpoint-population definition, adherence to the intended 2 times/day reporting schedule, and methods for handling incomplete entries are not reported in the registry record. These details would be important for assessing how much information contributed to the symptom endpoint.
Although the registry lists 28 outcome measures and 162 analyses, it does not report which comparisons were prespecified as primary beyond the stated endpoint, how secondary analyses were prioritized, or whether multiplicity was addressed. The statistical methods for the primary analysis are also not reported. The trial’s own sample-size justification and analysis populations are not reported in the registry record, and the numerical planning illustrations are not reported there.
Safety information is limited to selected participant counts and a serious-event term listed with 2.3%. The context and denominator for that term are not reported. Death counts and comparative safety estimates are also not reported. The enrolled population is described as healthy volunteers, so the record does not establish how findings would apply to other populations. These limitations concern what can be concluded from the registry record; they do not imply that unreported analyses were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate — NCT01568112.
- Registry record last updated 2016-06-13; status last verified 2016-05.
- Results first posted 2016-06-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01568112 is a completed randomized, quadruple-masked, parallel-group phase 3 study sponsored by Biogen. It enrolled 173 healthy volunteers and evaluated BG00012 with aspirin pretreatment, without aspirin pretreatment, or on a slow-titration schedule, alongside a placebo group. The study started in 2012-04 and reached primary completion in 2012-10.
The primary endpoint was the percentage of participants reporting overall flushing events during Day 1 to Week 8, assessed with the MFSS. The registry record does not report the primary outcome values or the statistical comparison. It reports serious AE counts of 0 of 44, 1 of 43, 0 of 43, and 0 of 42 across the placebo, BG00012, BG00012 + ASA, and BG00012 Slow Titration groups, respectively. The detailed statistical plan, missing-data handling, and multiplicity methods are not reported in the registry record.