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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 | Experimental |
| |
| Stage 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UK-453,061 | Drug | Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 | Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1. | Baseline, Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load | Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported. | Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose]) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss) | AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen. | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cologne | 50937 | Germany | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | UK-453,061 10 mg Twice Daily (Stage 1) | UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| FG001 | UK-453,061 30 mg Twice Daily (Stage 1) | UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| FG002 | UK-453,061 100 mg Twice Daily (Stage 1) | UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| FG003 | UK-453,061 500 mg Once Daily (Stage 1) | UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. |
| FG004 | Placebo Once/Twice Daily (Stage 1) | Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| FG005 | UK-453,061 750 mg Once Daily (Stage 2) | Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. |
| FG006 | UK-453,061 500 mg Twice Daily (Stage 2) | Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
| FG007 | UK-453,061 100 mg Once Daily (Stage 2) | Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. |
| FG008 | Placebo Once/Twice Daily (Stage 2) | Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
|
| |||||||||||||||||||||
| Stage 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UK-453,061 10 mg Twice Daily (Stage 1) | UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| BG001 | UK-453,061 30 mg Twice Daily (Stage 1) |
| 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 From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 | Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1. | Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 8 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | UK-453,061 10 mg Twice Daily (Stage 1) | UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C531151 | UK 453,061 |
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| UK-453,061 | Drug | Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days |
|
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
| Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
| Frankfurt am Main |
| 60590 |
| Germany |
| Pfizer Investigational Site | Hamburg | 20099 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
| BG002 | UK-453,061 100 mg Twice Daily (Stage 1) | UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| BG003 | UK-453,061 500 mg Once Daily (Stage 1) | UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. |
| BG004 | UK-453,061 750 mg Once Daily (Stage 2) | Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. |
| BG005 | UK-453,061 500 mg Twice Daily (Stage 2) | Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
| BG006 | UK-453,061 100 mg Once Daily (Stage 2) | Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. |
| BG007 | Placebo | Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| OG001 | UK-453,061 30 mg Twice Daily (Stage 1) | UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| OG002 | UK-453,061 100 mg Twice Daily (Stage 1) | UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. |
| OG003 | UK-453,061 500 mg Once Daily (Stage 1) | UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. |
| OG004 | UK-453,061 750 mg Once Daily (Stage 2) | Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. |
| OG005 | UK-453,061 500 mg Twice Daily (Stage 2) | Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
| OG006 | UK-453,061 100 mg Once Daily (Stage 2) | Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. |
| OG007 | Placebo | Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2. |
|
|
| Secondary | Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load | Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported. | Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement. | Posted | Number | participants | Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose]) |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss) | AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen. | Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration. | Posted | Geometric Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
|
|
|
| Other Pre-specified | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) | Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
|
|
|
| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) | Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration. | Posted | Median | Full Range | hrs | 0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8 |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | UK-453,061 30 mg Twice Daily (Stage 1) | UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. | 1 | 6 | 5 | 6 |
| EG002 | UK-453,061 100 mg Twice Daily (Stage 1) | UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1. | 0 | 6 | 5 | 6 |
| EG003 | UK-453,061 500 mg Once Daily (Stage 1) | UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1. | 0 | 6 | 5 | 6 |
| EG004 | UK-453,061 750 mg Once Daily (Stage 2) | Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2. | 0 | 6 | 6 | 6 |
| EG005 | UK-453,061 500 mg Twice Daily (Stage 2) | Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2. | 0 | 6 | 6 | 6 |
| EG006 | UK-453,061 100 mg Once Daily (Stage 2) | Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2. | 0 | 6 | 3 | 6 |
| EG007 | Placebo | Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2. | 0 | 6 | 4 | 6 |
| Tachycardia | Cardiac disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Chloropsia | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Anal chlamydia infection | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Protein total increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
| Phlebolith | Vascular disorders | MedDRA v10.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 4 days |
|
| 7 days |
|
| 13 days |
|
| 21 days |
|
| 31 to 33 days (follow-up) |
|