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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000146-13 | EudraCT Number |
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To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).
The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Experimental | Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
| Deoxycholic acid Injection 2 mg/cm² | Experimental | Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
| Deoxycholic acid Injection 4 mg/cm² | Experimental | Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
| Placebo | Placebo Comparator | Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic Acid Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale:
A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:
| From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Submental Fat (SMF) Rating Scale Score | The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Beddingfield, MD. PhD | Kythera Biopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Carina Heights | Australia | ||||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34115682 | Derived | Goodman GJ, Spelman LJ, Lowe N, Bowen B. Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat. Dermatol Surg. 2021 Aug 1;47(8):1065-1070. doi: 10.1097/DSS.0000000000003092. |
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Enrollment was conducted in 2 stages, an initial cohort in which preliminary safety and tolerability were evaluated and a second cohort (contingent cohort), which was enrolled after it had been determined that acceptable safety and tolerability were observed in the initial cohort. Participants from both cohorts were pooled for analysis.
The study was conducted at 6 study centers: 1 in the United Kingdom, 2 in Canada, and 3 in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| FG001 | Deoxycholic Acid Injection 2 mg/cm² | Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| FG002 | Deoxycholic Acid Injection 4 mg/cm² | Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| FG003 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| BG001 | Deoxycholic Acid Injection 2 mg/cm² |
| 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 | Number of Participants With Adverse Events | The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale:
A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:
| Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation. | Posted | Number | participants | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Kythera | clinical_trials@kythera.com |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| ID | Term |
|---|---|
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug |
|
| Change From Baseline in Subject Satisfaction With Appearance Rating Scale | The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement. | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
| Percentage of Participants With a Response in the Subject Global Improvement Rating | Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6. | 4 weeks after last treatment (up to 16 weeks after first dose) |
| Change From Baseline in Skin Laxity Rating | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement. | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) |
| Change From Baseline in the Cervicomental Angle | The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement. | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
| Gold Coast |
| Australia |
| Investigational Site | Toorak | Australia |
| Investigational Site | Oakville | Ontario | Canada |
| Investigational Site | Niagara Falls | Canada |
| Investigational Site | London | United Kingdom |
| Patient Request |
|
| Inability to Complete Study Procedure |
|
| Lost to Follow-up |
|
| Miscellaneous Reasons |
|
Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| BG002 | Deoxycholic Acid Injection 4 mg/cm² | Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| BG003 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Submental Fat (SMF) Rating | SMF Ratings:
| Number | participants |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:
| Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Deoxycholic Acid Injection 1 mg/cm² | Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| OG001 | Deoxycholic Acid Injection 2 mg/cm² | Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| OG002 | Deoxycholic Acid Injection 4 mg/cm² | Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| OG003 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
|
|
| Secondary | Change From Baseline in Submental Fat (SMF) Rating Scale Score | The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. | Safety/mITT population with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| Secondary | Change From Baseline in Subject Satisfaction With Appearance Rating Scale | The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement. | Safety/mITT population with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| Secondary | Percentage of Participants With a Response in the Subject Global Improvement Rating | Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6. | Safety/mITT population | Posted | Number | percentage of participants | 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| Secondary | Change From Baseline in Skin Laxity Rating | Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement. | Safety/mITT population with available data | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment) |
|
|
|
|
| Secondary | Change From Baseline in the Cervicomental Angle | The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement. | Safety/mITT population with available data | Posted | Mean | Standard Deviation | degrees | Baseline and 4 weeks after last treatment (up to 16 weeks after first dose) |
|
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations | Safety/mITT population | Posted | Number | participants | From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment). |
|
|
|
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | Deoxycholic Acid Injection 2 mg/cm² | Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 0 | 20 | 19 | 20 |
| EG002 | Deoxycholic Acid Injection 4 mg/cm² | Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 0 | 22 | 22 | 22 |
| EG003 | Placebo | Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 0 | 22 | 20 | 22 |
| Injection Site Swelling | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Haematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Anaesthesia | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Nodule | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Paraesthesia | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Oedema | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Discomfort | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D002757 | Cholanes |
Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. |
| 0.050 |
| LS Mean Difference |
| -0.4 |
| 2-Sided |
| 95 |
| -0.8 |
| 0.0 |
| No |
| Superiority or Other |
| ANCOVA | Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. | 0.249 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.7 | 0.2 | No | Superiority or Other |
Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. |
| 0.030 |
| LS Mean Difference |
| 1.4 |
| 2-Sided |
| 95 |
| 0.1 |
| 2.6 |
| No |
| Superiority or Other |
| ANCOVA | Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. | 0.012 | LS Mean Difference | 1.6 | 2-Sided | 95 | 0.4 | 2.8 | No | Superiority or Other |
| Difference from Placebo |
| 28.9 |
| 2-Sided |
| 95 |
| 0.4 |
| 57.5 |
| No |
| Superiority or Other |
| Fisher Exact | 0.003 | Difference from Placebo | 44.7 | 2-Sided | 95 | 20.6 | 68.8 | No | Superiority or Other |
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 24 |
|
Week 4
| Repeated easures |
Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. |
| 0.781 |
| LS Mean Difference |
| 0.0 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.4 |
| No |
| Superiority or Other |
| Week 4 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.146 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.1 | 0.5 | No | Superiority or Other |
| Week 8 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.076 | LS Mean Difference | 0.3 | 2-Sided | 95 | 0.0 | 0.6 | No | Superiority or Other |
| Week 8 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.975 | LS Mean Difference | 0.0 | 2-Sided | 95 | -0.3 | 0.3 | No | Superiority or Other |
| Week 8 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.183 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.1 | 0.5 | No | Superiority or Other |
| Week 12 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.017 | LS Mean Difference | 0.4 | 2-Sided | 95 | 0.1 | 0.7 | No | Superiority or Other |
| Week 12 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.022 | LS Mean Difference | 0.4 | 2-Sided | 95 | 0.1 | 0.7 | No | Superiority or Other |
| Week 12 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.081 | LS Mean Difference | 0.3 | 2-Sided | 95 | 0.0 | 0.6 | No | Superiority or Other |
| Week 16 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.510 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.2 | 0.4 | No | Superiority or Other |
| Week 16 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.330 | LS Mean Difference | -0.2 | 2-Sided | 95 | -0.5 | 0.2 | No | Superiority or Other |
| Week 16 | Repeated Measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.720 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.3 | 0.4 | No | Superiority or Other |
| Week 24 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.205 | LS Mean Difference | 0.2 | 2-Sided | 95 | -0.1 | 0.5 | No | Superiority or Other |
| Week 24 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.410 | LS Mean Difference | -0.1 | 2-Sided | 95 | -0.5 | 0.2 | No | Superiority or Other |
| Week 24 | Repeated measures | Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect. | 0.436 | LS Mean Difference | 0.1 | 2-Sided | 95 | -0.2 | 0.4 | No | Superiority or Other |
Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. |
| 0.248 |
| LS mean Difference |
| 5.2 |
| 2-Sided |
| 95 |
| -3.8 |
| 14.2 |
| No |
| Superiority or Other |
| ANCOVA | Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate. | 0.061 | LS Mean Difference | 9.3 | 2-Sided | 95 | -0.4 | 19.1 | No | Superiority or Other |
| Weight |
|
| Vital Signs |
|
| Physical Examinations |
|