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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002666-31 | EudraCT Number |
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This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).
Participants with each half-face randomized to one of the two following treatments:
The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ABPO Forte Gel | Experimental |
| |
| Part 1: ABPO Forte Vehicle Gel | Placebo Comparator |
| |
| Part 2: ABPO Forte Gel | Experimental |
| |
| Part 2: ABPO Forte Vehicle Gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABPO Forte Gel | Drug | Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Total Atrophic Acne Scar Count Per Half-face | The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. |
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Main Inclusion Criteria:
Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:
Participants with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face.
Participants with skin phototype of I to IV on Fitzpatrick's scale.
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markham | Ontario | Canada | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31209851 | Background | Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6. | |
| 29549588 |
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A total of 67 participants were randomized. All eligible participants had each half-face randomized to one of the two following treatments (with the other treatment applied to the other side of the face): ABPO forte gel and ABPO forte vehicle gel.
The study was conducted at 6 centers in Canada and France between 13 May 2016 and 23 November 2017. This study was conducted in 2 parts: Part 1 (Randomized) and Part 2 (Open Label).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants applied once-daily adapalene 0.3% - benzoyl peroxide (BPO) 2.5% (ABPO Forte) gel on half-face and ABPO Forte vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks were enrolled in Part 1 of the study. Thereafter, at the decision of the investigator, based on participant's medical assessment of efficacy during Part I, the participants who agreed to continue treatment with ABPO Forte gel for up to 24 additional weeks on the whole face were enrolled in Part 2 of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (Randomized): up to 24 Weeks |
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| Part 2 (Open Label): up to 48 Weeks |
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Intent-to-Treat (ITT) Population included all entire population enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants applied once-daily adapalene 0.3% - benzoyl peroxide (BPO) 2.5% (ABPO Forte) gel on half-face and ABPO Forte vehicle gel on the other side of the face based on randomization (right or left side of the face) at night for 24 weeks were enrolled in Part 1 of the study. Thereafter, at the decision of the investigator, based on participant's medical assessment of efficacy during Part I, the participants who agreed to continue treatment with ABPO Forte gel for up to 24 additional weeks on the whole face were enrolled in Part 2 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Part 1: Total Atrophic Acne Scar Count Per Half-face | The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. | The Intent-to-Treat efficacy population (ITT) included entire population enrolled and randomized. | Posted | Mean | Standard Deviation | atrophic acne scars | Week 24 |
|
Part 1: up to 24 weeks; Part 2: up to 48 weeks
The safety population included all randomized participants, after exclusion of participants who never took the treatment with certainty based on monitoring report.
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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 | Part 1: ABPO Forte Gel | Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2016 | Oct 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2017 | Oct 31, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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|
| Vehicle gel | Drug | Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2. |
|
| Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 |
| Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
| Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | ISGA was an assessment scale used to evaluate facial acne severity. ISGA was recorded using a 5-point scale ranges from 0 to 4, where (0 = clear [No visible scars from acne); 1 = almost clear [Hardly visible scars from 50 cm away]; 2 = mild [Easily recognizable; less than half the affected face area]; 3 = moderate [More than half and less than 75% of the affected face area]; 4 = severe [More than 75% of the affected face area]) based on inflammation, pustules and papulation/infiltration. Higher score indicated severe acne.](streamdown:incomplete-link) | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
| Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity | The investigator rated their preference on a scale ranging from -2 (left side a lot better than right) to 2 (right side a lot better than left). Overall scar severity was assessed using a 5-point scale where (-2 = Left a lot better than right; -1 = Left a little bit better than right; 0 = No preference; 1 = Right a little bit better than left; 2 = Right a lot better than left. ABPO forte was applied on left side and vehicle gel was applied on right side. | At Week 12 and Week 24 |
| Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and other lesions. The investigator counted all inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedone) and other lesions (nodules) for each half-face. | Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 |
| Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Inflammatory lesions included papules and pustules. Papule is a small, solid elevation less than one centimeter in diameter. Most of the lesion is above the surface of the skin. Pustule is a small, circumscribed elevation of the skin which contains yellow-white exudates. | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
| Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Non-inflammatory lesions included open comedone and closed comedone. Open comedone is a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed comedone is a mass of sebaceous material that is impacted behind a closed follicular orifice (white head). | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
| Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | IGA is an assessment scale used to determine severity of acne and clinical response to treatment on a 5-point scale (0 = clear [Clear skin with no inflammatory or non inflammatory lesions]; 1= almost clear [A few scattered comedones and a few small papules]; 2= mild [Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules]; 3= moderate [More than half of the face is involved. Many comedones, papules and pustules. One small nodule may be present] and 4= severe [Entire face is involved. Covered with comedones, numerous papules and pustules. Few nodules may or may not be present]) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
| Oakville |
| Ontario |
| Canada |
| Toronto | Ontario | Canada |
| Windsor | Ontario | Canada |
| Montreal | Quebec | Canada |
| Saint-Jérôme | Quebec | Canada |
| Nantes | France |
| Background |
| Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y. |
| Inadequate compliance to treatment |
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| Pregnancy |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Skin Phototype | Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, blue/green eyes, blond/red hair, always burns, does not tan; skin phototype II = fair skin, blue eyes; burns easily, tans poorly; skin phototype III = darker white skin, tans after initial burn; skin phototype IV = light brown skin, burns minimally, tans easily; skin phototype V = brown skin, rarely burns, tans darkly easily; skin phototype VI = dark brown or black skin, never burns, always tans darkly. | Count of Participants | Participants |
|
| Acne Duration | Mean | Standard Deviation | years |
|
Participants applied once-daily ABPO Forte gel on half-face based on randomization (right or left side of the face) at night for 24 weeks. |
| OG001 | Part 1: ABPO Forte Vehicle Gel | Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks. |
|
|
|
| Secondary | Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added. | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | atrophic acne scars | Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 |
|
|
|
| Secondary | Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit | The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars > 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
|
|
|
| Secondary | Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score | ISGA was an assessment scale used to evaluate facial acne severity. ISGA was recorded using a 5-point scale ranges from 0 to 4, where (0 = clear [No visible scars from acne); 1 = almost clear [Hardly visible scars from 50 cm away]; 2 = mild [Easily recognizable; less than half the affected face area]; 3 = moderate [More than half and less than 75% of the affected face area]; 4 = severe [More than 75% of the affected face area]) based on inflammation, pustules and papulation/infiltration. Higher score indicated severe acne.](streamdown:incomplete-link) | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | score on a scale | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
|
|
|
| Secondary | Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity | The investigator rated their preference on a scale ranging from -2 (left side a lot better than right) to 2 (right side a lot better than left). Overall scar severity was assessed using a 5-point scale where (-2 = Left a lot better than right; -1 = Left a little bit better than right; 0 = No preference; 1 = Right a little bit better than left; 2 = Right a lot better than left. ABPO forte was applied on left side and vehicle gel was applied on right side. | ITT population included entire population enrolled and randomized. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point. | Posted | Number | percentage of participants | At Week 12 and Week 24 |
|
|
|
| Secondary | Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and other lesions. The investigator counted all inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedone) and other lesions (nodules) for each half-face. | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48 |
|
|
|
| Secondary | Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Inflammatory lesions included papules and pustules. Papule is a small, solid elevation less than one centimeter in diameter. Most of the lesion is above the surface of the skin. Pustule is a small, circumscribed elevation of the skin which contains yellow-white exudates. | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
|
|
|
| Secondary | Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit | Non-inflammatory lesions included open comedone and closed comedone. Open comedone is a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed comedone is a mass of sebaceous material that is impacted behind a closed follicular orifice (white head). | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
|
|
|
| Secondary | Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit | IGA is an assessment scale used to determine severity of acne and clinical response to treatment on a 5-point scale (0 = clear [Clear skin with no inflammatory or non inflammatory lesions]; 1= almost clear [A few scattered comedones and a few small papules]; 2= mild [Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules]; 3= moderate [More than half of the face is involved. Many comedones, papules and pustules. One small nodule may be present] and 4= severe [Entire face is involved. Covered with comedones, numerous papules and pustules. Few nodules may or may not be present]) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). | ITT population included entire population enrolled and randomized. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | score on a scale | Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 |
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| 0 |
| 67 |
| 0 |
| 67 |
| 11 |
| 67 |
| EG001 | Part 1: ABPO Forte Vehicle Gel | Participants applied once-daily ABPO Forte vehicle gel on half-face based on randomization (right or left side of the face) at night for 24 weeks. | 0 | 67 | 0 | 67 | 5 | 67 |
| EG002 | Part 2: ABPO Forte Gel | Participants applied once-daily ABPO Forte gel on whole face for 48 weeks. | 0 | 45 | 0 | 45 | 14 | 45 |
| EG003 | Part 2: ABPO Forte Vehicle Gel | Participants applied once-daily ABPO Forte vehicle gel on whole face for 48 weeks. | 0 | 45 | 0 | 45 | 0 | 45 |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
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Not provided
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Week 24: ABPO Forte a lot better than Vehicle |
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| Week 24: ABPO Forte a little bit better than Vehicle |
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