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This is a multicenter, double-blinded, randomized, prospective, controlled clinical study to identify whether RHA® 3 is non-inferior to Restylane-L® for lip augmentation at Week 12 after the last treatment (initial or touch-up).
At screening, the treating investigator (TI) will evaluate the subject's lip fullness using the validated Teoxane Lip Fullness Scale (5-grade) for eligibility of the subject for the study.
At screening, the blinded live evaluator (BLE) will evaluate the subject's lip fullness using the TLFS to confirm eligibility and to establish a pre-treatment score for assessment of effectiveness.
Enrolled subjects will be randomly assigned in a 3:1 ratio to either the RHA® 3 or the Restylane-L® treatment group. Subjects will be blinded to the study treatment. The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection.
The study duration was extended from 36 to 52 weeks once all subjects had already been enrolled. Nearly 60% of the subjects consented to extend the study to 52 weeks before being eligible for repeat treatment. All data are presented up to 52 weeks (as well as 4 more weeks follow-up after retreatment at 36 or 52 weeks).
Subjects will be followed for 36 to 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 3, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented.
The subject will then be followed for an additional 4 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (36 or 52 weeks after the last treatment) will be considered the study Exit visit.
For subjects with re-treatment, the Exit visit will be 4 weeks after the re-treatment.
The TI will conduct safety and effectiveness evaluations at each study visit (up to 36 weeks or 52 (if applicable) weeks after the last treatment, and 4 weeks after re treatment) or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHA 3 | Experimental | Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks, optional retreatment at 36 or 52 Weeks. |
|
| Restylane- L | Active Comparator | Injection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHA 3 | Device | Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, as Assessed by the BLE | A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). Change = (Week 12 - Baseline score). | Week 12 after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TLFS Score as Assessed by the BLE at Visit 5 (Weeks 24 After Last Treatment), 6 (Weeks 36 After Last Treatment), 7 (Week 52 After Last Treatment) if Applicable, and Re-treatment (4 Weeks After Re-treatment) | A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Florida | Bradenton | Florida | 34209 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RHA 3 | Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks, optional retreatment at 36 or 52 Weeks. RHA 3: Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection. |
| FG001 | Control Device | Injection of control device into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks. Comparator Product: a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RHA 3 | Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks, retreatment at 36 or 52 Weeks. RHA 3: Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection. |
| 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 TLFS Score (Teoxane Lip Fullness Scale) Between Baseline and Week 12 After Last Treatment of RHA®3 Versus Control Device, as Assessed by the BLE | A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). Change = (Week 12 - Baseline score). | Primary endpoint on the mITT population | Posted | Mean | Standard Deviation | score on a scale | Week 12 after last treatment |
|
36 to 44 (for patients receiving re-treatment) weeks for subjects who did not consent to study extension. 52 to 60 (for patients receiving re-treatment) weeks for subjects who consented to the study extension
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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 | RHA 3 | Injection of RHA 3 into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Touch up treatment provided at 4 Weeks, retreatment at 36 or 52 Weeks. RHA 3: Investigational Product, RHA® 3 is a viscoelastic, sterile, non-pyrogenic, clear, colorless, homogenous, and biodegradable gel implant. It is formulated with sodium hyaluronic acid (NaHA) at a concentration of 23 mg/g obtained from bacterial fermentation using the Streptococcus equi bacterial strained, crosslinked with 1,4 butanediol diglycidyl ether (BDDE) and reconstituted in a physiological buffer (pH 7.3). RHA® 3 also contains 0.3% lidocaine hydrochloride to reduce pain on injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial aneurysm | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Mass | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | TEOXANE SA | +41(0) 22 344 96 36 | clinical@teoxane.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 | Mar 22, 2021 | Jan 13, 2025 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2021 | Jan 13, 2025 | SAP_005.pdf |
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| ID | Term |
|---|---|
| C562489 | Lymphoid Interstitial Pneumonia |
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|
| Restylane-L | Device | Comparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. |
|
| Weeks 36 and 52 after last treatment, week 4 after re-treatment |
| Responder Rate Calculated Using TLFS Assessed by the BLE | A responder will be defined as a subject who has a ≥1 grade improvement on the TLFS. The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). | Weeks 12, 36, 52 after last treatment, week 4 after re-treatment |
| Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 36, 52 After Last Treatment and 4 Weeks After Re-treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). | Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
| Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Lips" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 10 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied"). The subject will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. With your lips in mind, in the past week, how satisfied or dissatisfied have been with:", and will provide response. To calculate the FACE-Q, outcomes from all 10 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). | Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
| Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Outcome" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being "Definitely disagree" and 4 being "Definitely agree"). The subject will be instructed as follows: "We would like to know how you feel about your most recent procedure. For each question, select only one answer. Please indicate how much you agree or disagree with each statement:", and will provide response. To calculate the FACE-Q, outcomes from all 16questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). | Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
| Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. | Weeks 12, 36, 52 after last treatment, and 4 weeks after re-treatment |
| BG001 | Restylane- L | Injection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks. Restylane-L: Comparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
| Fitzpatrick Skin Type [1] | Fitzpatrick skin type as determined by the Treating Investigator on the skin tone scale developed to classify skin coloring and response to ultraviolet (UV) radiation. The scale contains 6 grades: I: Pale white skin; Always burns, does not tan. II: Fair skin; Burns easily, tans poorly. III: Darker white skin; Tans after initial burn. IV: Light brown skin; Burns minimally, tans easily. V: Brown skin; Rarely burns, tans darkly easily. VI: Dark brown or black skin; Never burns, always tans darkly. | Count of Participants | Participants |
|
| OG001 | Control Device | Injection of control device into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Optional touch up treatment provided at 4 Weeks. Control Device: a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. |
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| Secondary | Change From Baseline in TLFS Score as Assessed by the BLE at Visit 5 (Weeks 24 After Last Treatment), 6 (Weeks 36 After Last Treatment), 7 (Week 52 After Last Treatment) if Applicable, and Re-treatment (4 Weeks After Re-treatment) | A change in the TLFS ≥1 grade compared to pre-treatment will be considered clinically meaningful. The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). | mITT population | Posted | Mean | Standard Deviation | score on a scale | Weeks 36 and 52 after last treatment, week 4 after re-treatment |
|
|
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| Secondary | Responder Rate Calculated Using TLFS Assessed by the BLE | A responder will be defined as a subject who has a ≥1 grade improvement on the TLFS. The TLFS is a validated 5-point static scale for assessing lip augmentation. Possible scores range from 1 (Very Thin) to 5 (Very Full). | mITT population | Posted | Count of Participants | Participants | Weeks 12, 36, 52 after last treatment, week 4 after re-treatment |
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| Secondary | Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 36, 52 After Last Treatment and 4 Weeks After Re-treatment. | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). | mITT population | Posted | Count of Participants | Participants | Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
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| Secondary | Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Lips" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 10 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied"). The subject will be instructed as follows: "These questions ask about how you look right now. For each question, circle only one answer. With your lips in mind, in the past week, how satisfied or dissatisfied have been with:", and will provide response. To calculate the FACE-Q, outcomes from all 10 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). | mITT population | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
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| Secondary | Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Outcome" FACE-Q | Aesthetics© Scale Questionnaire at Weeks 12, 36, 52 After Last Treatment and 4 Week After Re-treatment. | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being "Definitely disagree" and 4 being "Definitely agree"). The subject will be instructed as follows: "We would like to know how you feel about your most recent procedure. For each question, select only one answer. Please indicate how much you agree or disagree with each statement:", and will provide response. To calculate the FACE-Q, outcomes from all 16questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). | mITT population | Posted | Mean | Standard Deviation | score on a scale | Weeks 12, 36, 52 after last treatment and 4 week after re-treatment. |
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| Secondary | Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse". The GAI will be assessed using the baseline photograph. | mITT population | Posted | Count of Participants | Participants | Weeks 12, 36, 52 after last treatment, and 4 weeks after re-treatment |
|
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|
| 0 |
| 153 |
| 0 |
| 153 |
| 75 |
| 153 |
| EG001 | Restylane- L | Injection of Restylane- L into into the vermillion body, vermillion border, and oral commissures of the lips (up to 3 ml with a max of 1.5 ml per lip), injected into the lip mucosa and/or mid to deep dermis as appropriate for lip augmentation. Touch up treatment provided at 4 Weeks. Restylane-L: Comparator Product, Restylane-L is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. | 0 | 49 | 1 | 49 | 22 | 49 |
| Injection Site Swelling | General disorders | Systematic Assessment |
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| Injection Site Induration | General disorders | Systematic Assessment |
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| Injection Site Bruising | General disorders | Systematic Assessment |
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| Injection Site Pain | General disorders | Systematic Assessment |
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| Injection Site Erosion | General disorders | Systematic Assessment |
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| Injection Site Reaction | General disorders | Systematic Assessment |
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| Injection Site Deformation | General disorders | Systematic Assessment |
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| Injection Site Exfoliation | General disorders | Systematic Assessment |
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| Injection Site Hypoaesthesia | General disorders | Systematic Assessment |
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| Injection Site Discolouration | General disorders | Systematic Assessment |
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| Injection Site Movement Impairment | General disorders | Systematic Assessment |
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| Injection Site Discomfort | General disorders | Systematic Assessment |
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| Injection Site Dryness | General disorders | Systematic Assessment |
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| Injection Site Hyperaesthesia | General disorders | Systematic Assessment |
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| Injection Site Paraesthesia | General disorders | Systematic Assessment |
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| Injection Site Scab | General disorders | Systematic Assessment |
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| Swelling Face | General disorders | Systematic Assessment |
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| Injection Site Haemorrhage | General disorders | Systematic Assessment |
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| Injection Site Vesicles | General disorders | Systematic Assessment |
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| Covid-19 | Infections and infestations | Systematic Assessment |
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| Injection Site Infection | Infections and infestations | Systematic Assessment |
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| Oral Herpes | Infections and infestations | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Ear Infection | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Intracranial Aneurysm | Nervous system disorders | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dermal Cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Chapped Lips | Gastrointestinal disorders | Systematic Assessment |
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| Salivary Gland Pain | Gastrointestinal disorders | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tendon Rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Haemorrhagic Ovarian Cyst | Reproductive system and breast disorders | Systematic Assessment |
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| Week 52 after last treatment |
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| Re-treatment: 4weeks post re-treatment at week 36 |
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| Re-treatment: 4 weeks post re-treatment at week 52 |
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| Week 36 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 4weeks post re-treatment at week 36 |
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| Re-treatment: 4weeks post re-treatment at week 52 |
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| Week 36 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 4 weeks post re-treatment at week 36 |
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| Re-treatment: 4 weeks post re-treatment at week 52 |
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| Week 36 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 4weeks post re-treatment at week 36 |
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| Re-treatment: 4weeks post re-treatment at week 52 |
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| Week 36 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 4weeks post re-treatment at week 36 |
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| Re-treatment: 4weeks post re-treatment at week 52 |
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| Week 36 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 4weeks post re-treatment at week 36 |
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| Re-treatment: 4weeks post re-treatment at week 52 |
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