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This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Study Product | Experimental | Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) |
|
| Reference Product | Active Comparator | Injection with Sculptra Aesthetic reconstituted with 5ml SWFI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra Aesthetic 8ml | Device | Treatment of nasolabial folds |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks |
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Inclusion Criteria:
Exclusion Criteria:
Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Scottsdale | Arizona | 85255 | United States | ||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Study Product | Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) Sculptra Aesthetic 8ml: Treatment of nasolabial folds |
| FG001 | Reference Product | Injection with Sculptra Aesthetic reconstituted with 5ml SWFI Sculptra Aesthetic 5ml: Treatment of nasolabial folds |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Study Product | Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) Sculptra Aesthetic 8ml: Treatment of nasolabial folds |
| BG001 | Reference Product |
| 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 in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session. | Posted | Mean | 95% Confidence Interval | units on a scale | 48 weeks |
|
48 weeks
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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 | Investigational Study Product | Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) Sculptra Aesthetic 8ml: Treatment of nasolabial folds |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 21.1 | Systematic Assessment | right eye |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoesthesia oral | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | 817-961-5000 | aestheticclinicaltrials@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 | Feb 21, 2019 | Jul 26, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2019 | Aug 1, 2022 | SAP_003.pdf |
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| Sculptra Aesthetic 5ml |
| Device |
Treatment of nasolabial folds |
|
| Weeks 16, 24, 32, and 40 |
| Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject | Weeks 16, 24, 32, 40, and 48. |
| Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator | Weeks 16, 24, 32, 40 and 48 |
| FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction | Baseline and at weeks 24, 32, 40 and 48 |
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. | Week 16, 24, 32, 40 and 48 |
| Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. | Week 16, 24, 32, 40 and 48 |
| Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | Subjects were asked to complete the following questions in the subject diary:
| time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12 |
| Solana Beach |
| California |
| 92075 |
| United States |
| Galderma Study Site | Bradenton | Florida | 34209 | United States |
| Galderma Study Site | Austin | Texas | 78746 | United States |
| Galderma Study Site | Spring | Texas | 77388 | United States |
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type (FST) | Measure Description: I (White, very fair, red or blond hair, blue eyes, freckles) II (White, fair, red or blond hair; blue, hazel or green eyes) III (Cream white, fair with any eye or hair color, very common) IV (Brown, typical Mediterranean Caucasian skin) V (Dark brown, Middle Eastern skin type) VI (Black) | Count of Participants | Participants |
|
| Reference Product |
Injection with Sculptra Aesthetic reconstituted with 5ml SWFI Sculptra Aesthetic 5ml: Treatment of nasolabial folds |
|
|
| Secondary | Change in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks | Intent-to-Treat Population, Observed cases | Posted | Mean | Standard Deviation | units on a scale | Weeks 16, 24, 32, and 40 |
|
|
|
| Secondary | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject | Intent-to-Treat Population, observed cases | Posted | Count of Participants | Participants | Weeks 16, 24, 32, 40, and 48. |
|
|
|
| Secondary | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator | Intent-to-Treat Population, Observed cases | Posted | Count of Participants | Participants | Weeks 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction | Intent-to-Treat Population, Observed cases | Posted | Mean | Standard Deviation | score on a scale | Baseline and at weeks 24, 32, 40 and 48 |
|
|
|
| Secondary | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | No | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. | ITT- observed cases | Posted | Count of Participants | Participants | Week 16, 24, 32, 40 and 48 |
|
|
|
| Secondary | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | Subjects were asked to complete the following questions in the subject diary:
| Intent-to-Treat Population | Posted | Median | Inter-Quartile Range | time in hours | time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12 |
|
|
|
| 0 |
| 59 |
| 2 |
| 59 |
| 7 |
| 59 |
| EG001 | Reference Product | Injection with Sculptra Aesthetic reconstituted with 5ml SWFI Sculptra Aesthetic 5ml: Treatment of nasolabial folds | 0 | 21 | 0 | 21 | 7 | 21 |
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Injection site hypoaesthesia | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Injection site paraesthesia | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Injection site induration | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Injection site nodule | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Injection site pain | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Swelling | General disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Herpes simplex | Infections and infestations | MedDRA 21.1 | Systematic Assessment | related |
|
| Oral herpes | Infections and infestations | MedDRA 21.1 | Systematic Assessment | related |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment | related |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment | related |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment | related |
|
PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites
| Week 16- Right NLF |
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| Week 24- Left NLF |
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| Week 24- Right NFL |
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| Week 32- Left NLF |
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| Week 32- Right NLF |
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| Week 40- Left NLF |
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| Week 40- Right NLF |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
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| Dissatisfied |
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| Very Dissatisfied |
|
| Week 24 |
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| Week 32 |
|
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| Week 40 |
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| Week 48 |
|
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
|
| Dissatisfied |
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| Very Dissatisfied |
|
| Week 24 |
|
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Satisfied |
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| Neutral (not satisfied or dissatisfied) |
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| Dissatisfied |
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| Very Dissatisfied |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
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| Dissatisfied |
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| Very Dissatisfied |
|
| Week 24 |
|
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| Week 32 |
|
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| Week 40 |
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| Week 48 |
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| Satisfied |
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| Neutral |
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| Dissatisfied |
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| Very Dissatisfied |
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| Week 24 |
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| Week 32 |
|
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| Week 40 |
|
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| Week 48 |
|
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 24 |
|
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| Week 32 |
|
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| Week 40 |
|
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| Week 48 |
|
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 24 |
|
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| Week 32 |
|
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| Week 40 |
|
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| Week 48 |
|
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| Satisfied |
|
| Neutral (not satisfied or dissatisfied) |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Week 24 |
|
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| Week 32 |
|
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| Week 40 |
|
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| Week 48 |
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| Agree |
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| Neither agree or disagree |
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| Disagree |
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| Strongly Disagree |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| Agree |
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| Neither agree or disagree |
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| Disagree |
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| Strong Disagree |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| No |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| No |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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| After treatment 2 |
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| After treatment 3 |
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| After treatment 4 |
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