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This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFX453 0.1% NMC | Experimental | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
|
| LFX453 0.15% LCC | Experimental | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
|
| Vehicle to NMC | Placebo Comparator | Vehicle to nanomedicinal cream (NMC) Twice daily applications |
|
| Vehicle to LCC | Placebo Comparator | Vehicle to liquid crystal cream (LCC) Twice daily applications |
|
| Aldara | Active Comparator | Aldara cream 3 applications per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Treatment | Drug | Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks | Number of participants with at least one AE/SAE in the category up to 20 weeks | 20 weeks |
| Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined | Week 20 |
| Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined | Baseline, Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined | week 8, week 16 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Vienna | 1040 | Austria | |||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
Not provided
Not provided
A total of 82 patients, male and female of non-childbearing potential aged 18-75 years, with Actinic Keratosis (AK) on the face or balding scalp were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
| FG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
| FG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications |
| FG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications |
| FG004 | Aldara | Aldara cream 3 applications per week |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
| BG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
| 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 Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks | Number of participants with at least one AE/SAE in the category up to 20 weeks | The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis. | Posted | Number | participants | 20 weeks |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035703 | Therapies, Investigational |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
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| Active comparator | Drug | Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up. |
|
| Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined | Week 20 |
| Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined | week 8, week 16 |
| Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined | Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined | Baseline, Week 8 |
| Copenhagen NV |
| DK-2400 |
| Denmark |
| Novartis Investigative Site | Berlin | 10098 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Bonn | 53111 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Kopavogur | 201 | Iceland |
| Novartis Investigative Site | London | E1 1BB | United Kingdom |
| Subject/guardian decision |
|
| BG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications |
| BG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications |
| BG004 | Aldara | Aldara cream 3 applications per week |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Vehicle to NMC |
Vehicle to nanomedicinal cream (NMC) Twice daily applications |
| OG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications |
| OG004 | Aldara | Aldara cream 3 applications per week |
|
|
| Primary | Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Number | participants | Week 20 |
|
|
|
|
| Secondary | Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined | Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Number | participants | week 8, week 16 |
|
|
|
| Secondary | Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Number | participants | Week 20 |
|
|
|
| Secondary | Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined | Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Number | participants | week 8, week 16 |
|
|
|
| Primary | Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined | Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 20 |
|
|
|
| Secondary | Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined | Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined | Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 8 |
|
|
|
| 1 |
| 20 |
| 10 |
| 20 |
| EG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications | 1 | 20 | 14 | 20 |
| EG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications | 1 | 11 | 9 | 11 |
| EG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications | 1 | 10 | 8 | 10 |
| EG004 | Aldara | Aldara cream 3 applications per week | 1 | 21 | 17 | 21 |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| APHTHOUS ULCER | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| APICAL GRANULOMA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| APPLICATION SITE COLDNESS | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| APPLICATION SITE ERYTHEMA | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| APPLICATION SITE PRURITUS | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| APPLICATION SITE SCAB | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| HYPOTHERMIA | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| EYE INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| RELAPSING FEVER | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| CORNEAL ABRASION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| EYELID INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| MUSCLE RUPTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| PERIORBITAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| ANTIPSYCHOTIC DRUG LEVEL INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| MYOSCLEROSIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| SEBORRHOEIC KERATOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| AUTONOMIC NERVOUS SYSTEM IMBALANCE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| BURNING SENSATION | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| POLYNEUROPATHY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| POOR QUALITY SLEEP | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| AGITATION | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| BURNOUT SYNDROME | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| RENAL CYST | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D017437 |
| Skin and Connective Tissue Diseases |
| 0.517 |
| Mean Difference (Net) |
| 0.00 |
| Standard Deviation |
| 0.07 |
| 2-Sided |
| 90 |
| -0.12 |
| 0.13 |
| Non-Inferiority or Equivalence (legacy) |
p value is provided |
| Week 16 |
|
| Week 16 |
|