Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TRAMMAPPAI4033 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).
This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. Participants' safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol hydrochloride/acetaminophen | Experimental | Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol hydrochloride | Drug | Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale Score at Day 14 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Day 14 |
| Pain Visual Analog Scale Score at Day 28 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Day 28 |
| Pain Visual Analog Scale Score at Day 56 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Categorical Scores on Pain Relief Rating Scale | Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete. | Day 14, 28 and 56 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Taiwan Ltd Clinical Trial | Johnson & Johnson Taiwan Ltd | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol Hydrochloride/Acetaminophen | Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol Hydrochloride/Acetaminophen | Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
| 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 | Pain Visual Analog Scale Score at Day 14 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Millimeter (mm) | Day 14 |
|
Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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 | Tramadol Hydrochloride/Acetaminophen | Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA Version 12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Janssen Pharmaceutics Taiwan | +886-2-23762155 |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acetaminophen | Drug | Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. |
|
| Tender-Point Evaluation/ Myalgic Score | Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening. | Baseline and Day 56 |
| Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was "How long did it usually take for participant to fall asleep during the past 4 weeks" and Q2 was "On the average, how many hours did participant sleep each night during the past 4 weeks". | Baseline and Day 56 |
| Participant Assessment Sleep Questionnaire Score | Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to "How often during past 4 weeks did participant felt" and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement. | Baseline and Day 56 |
| Total Fibromyalgia Impact Questionnaire (FIQ) Score | The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening. | Baseline and Day 56 |
| Number of Participants With Physician Global Assessment | The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor. | Day 14, 28 and 56 |
| Number of Participants With Subject's Global Assessment | Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor. | Day 14, 28 and 56 |
| Protocol Violation |
|
| Participant took prohibited medication |
|
| Receive other anti-neoplastic treatment |
|
| Insufficient therapy |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Visual Analog Scale at Baseline | Assessed by 100 mm of VAS from 0 to 100, where 0 mm=no pain and 10 mm=worse pain. | Mean | Standard Deviation | Units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pain Visual Analog Scale Score at Day 28 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Millimeter (mm) | Day 28 |
|
|
|
| Primary | Pain Visual Analog Scale Score at Day 56 | Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Millimeter (mm) | Day 56 |
|
|
|
| Secondary | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete. | The ITT population included all enrolled participants. | Posted | Number | Participants | Day 14, 28 and 56 |
|
|
|
| Secondary | Tender-Point Evaluation/ Myalgic Score | Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening. | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 56 |
|
|
|
| Secondary | Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was "How long did it usually take for participant to fall asleep during the past 4 weeks" and Q2 was "On the average, how many hours did participant sleep each night during the past 4 weeks". | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Hours | Baseline and Day 56 |
|
|
|
| Secondary | Participant Assessment Sleep Questionnaire Score | Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to "How often during past 4 weeks did participant felt" and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement. | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 56 |
|
|
|
| Secondary | Total Fibromyalgia Impact Questionnaire (FIQ) Score | The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening. | The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 56 |
|
|
|
| Secondary | Number of Participants With Physician Global Assessment | The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor. | The ITT population included all enrolled participants. | Posted | Number | Participants | Day 14, 28 and 56 |
|
|
|
| Secondary | Number of Participants With Subject's Global Assessment | Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor. | The ITT population included all enrolled participants. | Posted | Number | Participants | Day 14, 28 and 56 |
|
|
|
| 2 |
| 80 |
| 49 |
| 80 |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dermatomyositis | Immune system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Drug eruption | Immune system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Akathisia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Anorexia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Decreased appetite | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Ecchymosis | Vascular disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Adenoviral upper respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
Not provided
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| Title | Measurements |
|---|---|
|
| None:Day 14 |
|
| Worse:Day 14 |
|
| Missing:Day 14 |
|
| A lot:Day 28 |
|
| Moderate:Day 28 |
|
| Slight:Day 28 |
|
| None:Day 28 |
|
| Worse:Day 28 |
|
| Missing:Day 28 |
|
| A lot:Day 56 |
|
| Moderate:Day 56 |
|
| Slight:Day 56 |
|
| None:Day 56 |
|
| Worse:Day 56 |
|
| Missing:Day 56 |
|
|
| Myalgic Score (left side):Baseline |
|
| Tender-Point Evaluation (right side):Day 56 |
|
| Myalgic Score (right side):Day 56 |
|
| Tender-Point Evaluation (left side):Day 56 |
|
| Myalgic Score (left side):Day 56 |
|
| Title | Measurements |
|---|---|
|
| Question 2: Day 56 |
|
| Title | Measurements |
|---|---|
|
| Question 6: Baseline |
|
| Question 7: Baseline |
|
| Question 8: Baseline |
|
| Question 9: Baseline |
|
| Question 10: Baseline |
|
| Question 11: Baseline |
|
| Question 12: Baseline |
|
| Question 3: Day 56 |
|
| Question 4: Day 56 |
|
| Question 5: Day 56 |
|
| Question 6: Day 56 |
|
| Question 7: Day 56 |
|
| Question 8: Day 56 |
|
| Question 9: Day 56 |
|
| Question 10: Day 56 |
|
| Question 11: Day 56 |
|
| Question 12: Day 56 |
|
| Title | Measurements |
|---|---|
|
| Q1: Poor (Day 14) |
|
| Q1: Very poor (Day 14) |
|
| Q1: Missing (Day 14) |
|
| Q2: Very good (Day 14) |
|
| Q2: Good (Day 14) |
|
| Q2: Moderate (Day 14) |
|
| Q2: Poor (Day 14) |
|
| Q2: Very poor (Day 14) |
|
| Q2: Missing (Day 14) |
|
| Q3: Very good (Day 14) |
|
| Q3: Good (Day 14) |
|
| Q3: Moderate (Day 14) |
|
| Q3: Poor (Day 14) |
|
| Q3: Very poor (Day 14) |
|
| Q3: Missing (Day 14) |
|
| Q1: Very good (Day 28) |
|
| Q1: Good (Day 28) |
|
| Q1: Moderate (Day 28) |
|
| Q1: Poor (Day 28) |
|
| Q1: Very poor (Day 28) |
|
| Q1: Missing (Day 28) |
|
| Q2: Very good (Day 28) |
|
| Q2: Good (Day 28) |
|
| Q2: Moderate (Day 28) |
|
| Q2: Poor (Day 28) |
|
| Q2: Very poor (Day 28) |
|
| Q2: Missing (Day 28) |
|
| Q3: Very good (Day 28) |
|
| Q3: Good (Day 28) |
|
| Q3: Moderate (Day 28) |
|
| Q3: Poor (Day 28) |
|
| Q3: Very poor (Day 28) |
|
| Q3: Missing (Day 28) |
|
| Q1: Very good (Day 56) |
|
| Q1: Good (Day 56) |
|
| Q1: Moderate (Day 56) |
|
| Q1: Poor (Day 56) |
|
| Q1: Very poor (Day 56) |
|
| Q1: Missing (Day 56) |
|
| Q2: Very good (Day 56) |
|
| Q2: Good (Day 56) |
|
| Q2: Moderate (Day 56) |
|
| Q2: Poor (Day 56) |
|
| Q2: Very poor (Day 56) |
|
| Q2: Missing (Day 56) |
|
| Q3: Very good (Day 56) |
|
| Q3: Good (Day 56) |
|
| Q3: Moderate (Day 56) |
|
| Q3: Poor (Day 56) |
|
| Q3: Very poor (Day 56) |
|
| Q3: Missing (Day 56) |
|
| Title | Measurements |
|---|---|
|
| Q1: Poor (Day 14) |
|
| Q1: Very poor (Day 14) |
|
| Q1: Missing (Day 14) |
|
| Q2: Very good (Day 14) |
|
| Q2: Good (Day 14) |
|
| Q2: Moderate (Day 14) |
|
| Q2: Poor (Day 14) |
|
| Q2: Very poor (Day 14) |
|
| Q2: Missing (Day 14) |
|
| Q3: Very good (Day 14) |
|
| Q3: Good (Day 14) |
|
| Q3: Moderate (Day 14) |
|
| Q3: Poor (Day 14) |
|
| Q3: Very poor (Day 14) |
|
| Q3: Missing (Day 14) |
|
| Q1: Very good (Day 28) |
|
| Q1: Good (Day 28) |
|
| Q1: Moderate (Day 28) |
|
| Q1: Poor (Day 28) |
|
| Q1: Very poor (Day 28) |
|
| Q1: Missing (Day 28) |
|
| Q2: Very good (Day 28) |
|
| Q2: Good (Day 28) |
|
| Q2: Moderate (Day 28) |
|
| Q2: Poor (Day 28) |
|
| Q2: Very poor (Day 28) |
|
| Q2: Missing (Day 28) |
|
| Q3: Very good (Day 28) |
|
| Q3: Good (Day 28) |
|
| Q3: Moderate (Day 28) |
|
| Q3: Poor (Day 28) |
|
| Q3: Very poor (Day 28) |
|
| Q3: Missing (Day 28) |
|
| Q1: Very good (Day 56) |
|
| Q1: Good (Day 56) |
|
| Q1: Moderate (Day 56) |
|
| Q1: Poor (Day 56) |
|
| Q1: Very poor (Day 56) |
|
| Q1: Missing (Day 56) |
|
| Q2: Very good (Day 56) |
|
| Q2: Good (Day 56) |
|
| Q2: Moderate (Day 56) |
|
| Q2: Poor (Day 56) |
|
| Q2: Very poor (Day 56) |
|
| Q2: Missing (Day 56) |
|
| Q3: Very good (Day 56) |
|
| Q3: Good (Day 56) |
|
| Q3: Moderate (Day 56) |
|
| Q3: Poor (Day 56) |
|
| Q3: Very poor (Day 56) |
|
| Q3: Missing (Day 56) |
|