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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMEQ(a) | Other Identifier | Eli Lilly and Company |
Not provided
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | 60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) |
|
| Placebo | Placebo Comparator | Placebo every day (QD), by mouth (PO) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine Hydrochloride | Drug | 60 mg every day (QD) (morning or evening), by mouth (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beijing | 100101 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21163113 | Result | Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) |
| FG001 | Placebo | Placebo every day (QD), by mouth (PO) for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug | Placebo every day (QD), by mouth (PO) |
|
| Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Baseline and 12 weeks |
| Time Course of Change in Patient Global Impression - Improvement Scale | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | baseline, over 12 weeks |
| Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. | Baseline and 12 weeks |
| Number of Participants Discontinuing Due to Adverse Events | over 12 weeks |
| Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events. | over 12 weeks |
| Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15. | Baseline and 12 weeks |
| Vital Signs - Weight | Change from baseline to endpoint in body weight. | Baseline and 12 weeks |
| Vital Signs - Pulse Rate | Change from baseline to endpoint in pulse rate. | Baseline and 12 weeks |
| Vital Signs - Blood Pressure | Change from baseline to endpoint in systolic and diastolic blood pressure. | Baseline and 12 weeks |
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides. | Baseline and 12 weeks |
| Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Significantly different laboratory values between the two groups in baseline to endpoint changes | Baseline and 12 weeks |
| China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Changsha | 410011 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Harbin | 150086 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanjin | 210012 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanjing | 210029 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shanghai | 200233 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wuhan | 430022 | China |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
Placebo every day (QD), by mouth (PO) for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Major Depressive Disorder | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Type of Diabetes Mellitus | Number | participants |
|
| Beck Depression Inventory-II Total Score | A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory 24-Hour Average Pain Score | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impressions of Severity Score | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Mean | Standard Deviation | units on a scale |
|
| Diabetic Neuropathy History | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Michigan Neuropathy Screening Instrument | Assesses degree of neuropathy. Responses to 13 out of 15 items are added to obtain total score. Responses of "yes" to items 1,2,3,5,6,8,9,11,12,14,15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Items 4 and 10 are not included in scoring. Total scores range from 0 (no neuropathy) to 13 (severe neuropathy). | Mean | Standard Deviation | units on a scale |
|
| Weight | Mean | Standard Deviation | kilograms |
|
Placebo every day (QD), by mouth (PO) for 12 weeks |
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores | Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10). | Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Time Course of Change in Patient Global Impression - Improvement Scale | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). | Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline, over 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score) | The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement. | Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Number of Participants Discontinuing Due to Adverse Events | Intention to Treat Analysis. All randomized patients. | Posted | Number | participants | over 12 weeks |
|
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening) | Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events. | Number of randomized patients in each treatment arm for each dosing group | Posted | Number | participants | over 12 weeks |
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item | Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15. | Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Vital Signs - Weight | Change from baseline to endpoint in body weight. | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | kilograms | Baseline and 12 weeks |
|
|
|
|
| Secondary | Vital Signs - Pulse Rate | Change from baseline to endpoint in pulse rate. | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | beats per minute | Baseline and 12 weeks |
|
|
|
|
| Secondary | Vital Signs - Blood Pressure | Change from baseline to endpoint in systolic and diastolic blood pressure. | Number of randomized patients with a baseline and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides | Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides. | Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits. | Posted | Mean | Standard Deviation | millimole/Liter | Baseline and 12 weeks |
|
|
|
|
| Secondary | Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid | Significantly different laboratory values between the two groups in baseline to endpoint changes | Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline and 12 weeks |
|
|
|
|
| 2 |
| 77 |
| EG001 | Duloxetine 60/120 mg QD | Duloxetine 60/120 mg QD | 2 | 85 |
| Cardiac failure acute | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Therapeutic response unexpected | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| Pain Right Now Score |
|
| Average Interference Score |
|
Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline. |
| 0.151 |
P-value for Least Pain Score |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline. | 0.012 | P-value for Pain Right Now Score | 95 | No | Superiority or Other |
| ANCOVA | Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline. | 0.077 | P-value for Average Interference Score | 95 | No | Superiority or Other |
| Week 4 (N=94, N=101) |
|
| Week 8 (N=91, N=95) |
|
| Week 12 (N=87, N=92) |
|
| Mixed Models Analysis |
Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit. |
| 0.004 |
P-value for Visit 4 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit. | 0.037 | P-value for Visit 5 | 95 | No | Superiority or Other |
| Mixed Models Analysis | Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit. | <0.001 | P-value for Visit 6 | 95 | No | Superiority or Other |
| Mixed Models Analysis | Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit. | 0.028 | P-value for Visit 7 | 95 | No | Superiority or Other |
| Abdominal distension |
|
| Abdominal pain upper |
|
| Anorexia |
|
| Arthralgia |
|
| Asthenia |
|
| Chest discomfort |
|
| Constipation |
|
| Cough |
|
| Decreased appetite |
|
| Diarrhoea |
|
| Dizziness |
|
| Dry mouth |
|
| Dyslipidaemia |
|
| Dysuria |
|
| Fatigue |
|
| Headache |
|
| Hyperhidrosis |
|
| Hypersomnia |
|
| Hypoglycaemia |
|
| Insomnia |
|
| Lethargy |
|
| Nausea |
|
| Pain |
|
| Palpitations |
|
| Pruritus |
|
| Somnolence |
|
| Stomach discomfort |
|
| Therapeutic response unexpected |
|
| Thirst |
|
| Vomiting |
|
Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline. |
| 0.590 |
P-value for 8-Item Score |
| 95 |
| No |
| Superiority or Other |
Model=Treatment and Pooled Investigator
| 0.601 |
P-value for Diastolic Blood Pressure |
| 95 |
| No |
| Superiority or Other |
| High Density Lipoprotein Cholesterol Baseline |
|
| High Density Lipoprotein Change to Endpoint |
|
| Sodium Baseline |
|
| Sodium Change to Endpoint |
|
| Triglycerides Baseline |
|
| Triglycerides Change to Endpoint |
|
Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value. |
| 0.005 |
P-value for High Density Lipoprotein Cholesterol |
| 95 |
| No |
| Superiority or Other |
| ANOVA | Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value. | 0.011 | P-value for Sodium | 95 | No | Superiority or Other |
| ANOVA | Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value. | 0.044 | P-value for triglycerides | 95 | No | Superiority or Other |