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| ID | Type | Description | Link |
|---|---|---|---|
| C2661002 | Other Identifier | Alias Study Number | |
| 2014-003243-34 | EudraCT Number |
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Study was terminated on 22Dec2017 due to slow enrollment; there were no safety or efficacy concerns.
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days
This is a multicentre, multinational, open-label, single treatment arm study of intravenous (IV) ceftaroline fosamil and ampicillin, plus an optional aminoglycoside of choice, in hospitalized neonates and young infants aged 7 to < 60 days with late-onset sepsis (LOS).
Baseline assessments for study eligibility will occur within 36 hours before administration of the first dose of study therapy. Study Day 1 is defined as the 24-hour period starting at the onset of the first administration of study therapy. Thereafter, subsequent Study Days are to follow the same pattern.
Safety assessments will occur throughout the study. Clinical outcome evaluations will occur at End-of-Therapy (EOT; within 24 hours after completion of last infusion) and Test-of-Cure (TOC; 8 to 15 days after the last dose of study therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline Fosamil | Experimental | Ceftaroline Fosamil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline Fosamil | Drug | Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Baseline up to SFU visit (up to a maximum study duration of 49 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Ceftaroline Fosamil | Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL). | At the end of infusion (EOI) |
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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 |
|---|---|---|---|---|---|---|
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States | ||
| Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet, Gyermekinfektologiai Osztaly |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091493 | Derived | Bradley JS, Stone GG, Chan PLS, Raber SR, Riccobene T, Mas Casullo V, Yan JL, Hendrick VM, Hammond J, Leister-Tebbe HK. Phase 2 Study of the Safety, Pharmacokinetics and Efficacy of Ceftaroline Fosamil in Neonates and Very Young Infants With Late-onset Sepsis. Pediatr Infect Dis J. 2020 May;39(5):411-418. doi: 10.1097/INF.0000000000002607. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline Fosamil: Young Infants | Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| FG001 | Ceftaroline Fosamil: Term Neonates | Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| FG002 | Ceftaroline Fosamil: Preterm Neonates | Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) analysis set consisted of all enrolled participants for whom informed consent form was signed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline Fosamil: Young Infants | Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| 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 Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil. | Posted | Count of Participants | Participants | Baseline up to SFU visit (up to a maximum study duration of 49 days) |
|
Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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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 | Ceftaroline Fosamil: Young Infants | Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Salmonellosis | Infections and infestations | MedDRA v20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2017 | Jun 18, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2018 | Jun 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D000667 | Ampicillin |
| D000617 | Aminoglycosides |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Ampicillin | Drug | Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care. |
|
| Aminoglycoside | Drug | Optional, will be given as per local standard of care. |
|
| Plasma Concentration of Ceftaroline |
Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL |
| At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI |
| Plasma Concentration of Ceftaroline M-1 | Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL | At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI |
| Percentage of Participants With Favorable Clinical Response | Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy. | EOT visit (up to Day 15), TOC visit (up to Day 29) |
| Percentage of Participants With Favorable Microbiological Response | Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug. | EOT visit (up to Day 15), TOC visit (up to Day 29) |
| Budapest |
| 1097 |
| Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Gyermek-, Koraszulott es Csecsemoosztaly | Budapest | 1125 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Gyermekosztaly | NyÃregyháza | 4400 | Hungary |
| BG001 | Ceftaroline Fosamil: Term Neonates | Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| BG002 | Ceftaroline Fosamil: Preterm Neonates | Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| BG003 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Ceftaroline Fosamil: Young Infants | Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| OG001 | Ceftaroline Fosamil: Term Neonates | Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
| OG002 | Ceftaroline Fosamil: Preterm Neonates | Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. |
|
|
| Secondary | Plasma Concentration of Ceftaroline Fosamil | Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL). | Pharmacokinetic (PK) analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | Posted | Number | ng/mL | At the end of infusion (EOI) |
|
|
|
| Secondary | Plasma Concentration of Ceftaroline | Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL | PK analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | Posted | Number | ng/mL | At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI |
|
|
|
| Secondary | Plasma Concentration of Ceftaroline M-1 | Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL | The PK analysis set will include all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected. | Posted | Number | ng/mL | At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI |
|
|
|
| Secondary | Percentage of Participants With Favorable Clinical Response | Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy. | Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy]). | Posted | Number | 95% Confidence Interval | percentage of participants | EOT visit (up to Day 15), TOC visit (up to Day 29) |
|
|
|
| Secondary | Percentage of Participants With Favorable Microbiological Response | Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug. | Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy).](streamdown:incomplete-link) | Posted | Number | 95% Confidence Interval | percentage of participants | EOT visit (up to Day 15), TOC visit (up to Day 29) |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Ceftaroline Fosamil: Term Neonates | Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG002 | Ceftaroline Fosamil: Preterm Neonates | Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. | 0 | 2 | 1 | 2 | 1 | 2 |
| Anaemia | Blood and lymphatic system disorders | MedDRA v20.0 | Non-systematic Assessment |
|
| Cerebral cyst | Nervous system disorders | MedDRA v20.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v20.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA v20.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA v20.0 | Non-systematic Assessment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA v20.0 | Non-systematic Assessment |
|
| Rhinitis | Renal and urinary disorders | MedDRA v20.0 | 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.
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Participant 3: At EOI |
|
| Participant 3: At 3 to 4 hours after EOI |
|
| Participant 4: At 15 minutes to 2 hours after EOI |
|
| Participant 4: At 5 to 7 hours after EOI |
|
| Participant 5: At EOI |
|
| Participant 6: 15 minutes to 2 hours after EOI |
|
| Participant 7: At 15 minutes to 2 hours after EOI |
|
| Participant 7: At 5 to 7 hours after EOI |
|
| Participant 8:At 15 minutes to 2 hours after EOI |
|
| Participant 8: At 5 to 7 hours after EOI |
|
| Participant 9: At 15 minutes to 2 hours after EOI |
|
| Participant 9: At 5 to 7 hours after EOI |
|
| Participant 10: At EOI |
|
| Participant 10: At 3 to 4 hours after EOI |
|
| Participant 11: At 15 minutes to 2 hours after EOI |
|
| Participant 11: At 5 to 7 hours after EOI |
|
| Title | Measurements |
|---|---|
|
| Participant 3: At EOI |
|
| Participant 3: At 3 to 4 hours after EOI |
|
| Participant 4: At 15 minutes to 2 hours after EOI |
|
| Participant 4: At 5 to 7 hours after EOI |
|
| Participant 5: At EOI |
|
| Participant 6: At 15 minutes to 2 hours after EOI |
|
| Participant 7: At 15 minutes to 2 hours after EOI |
|
| Participant 7: At 5 to 7 hours after EOI |
|
| Participant 8: At 15 minutes to 2 hours after EOI |
|
| Participant 8: At 5 to 7 hours after EOI |
|
| Participant 9: At 15 minutes to 2 hours after EOI |
|
| Participant 9: At 5 to 7 hours after EOI |
|
| Participant 10: At EOI |
|
| Participant 10: At 3 to 4 hours after EOI |
|
| Participant 11: At 15 minutes to 2 hours after EOI |
|
| Participant 11: At 5 to 7 hours after EOI |
|
|
|