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The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirasol | Experimental | Transfusions with Mirasol-treated whole blood |
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| Control | Active Comparator | Transfusions with untreated whole blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirasol-treated Whole Blood | Device | Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Incidence of Transfusion-transmitted Malaria | Percentage of Participants who contracted transfusion-transmitted malaria (TTM) | Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Contamination of Fresh Whole Blood (FWB) Products | Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Owusu-Ofori, MD | Komfo Anokye Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Komfo Anokye Teaching Hospital | Kumasi | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27116282 | Derived | Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S. Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet. 2016 Apr 23;387(10029):1753-61. doi: 10.1016/S0140-6736(16)00581-X. |
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227 total were enrolled, but one participant was ineligible prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirasol | Transfusions with Mirasol-treated whole blood Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood |
| FG001 | Control | Transfusions with untreated whole blood Untreated Whole Blood: Transfusion with fresh Whole Blood |
| FG002 | Unassigned | Enrolled subjects who became ineligible prior to randomization to either Mirasol or Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population = all randomized subjects who underwent at least 1 study transfusion, independent of the outcome or successful completion of the procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirasol | Transfusions with Mirasol-treated whole blood Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Participants With Incidence of Transfusion-transmitted Malaria | Percentage of Participants who contracted transfusion-transmitted malaria (TTM) | Evaluable population = randomized subjects who received up to 2 whole blood transfusions and no non-study blood products, who did not receive any anti-malarial treatment, who had no significant protocol deviations and who additionally were non parasitemic pre-transfusion and received at least one parasitemic fresh whole blood product | Posted | Number | Percentage of participants | Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion) |
|
28 days
From the time of the initial transfusion through the 28-day Final Follow-up Visit
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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 | Mirasol | Transfusions with Mirasol-treated whole blood Mirasol-treated Whole Blood: Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
Necessary powering for the overall number of transfusions even though a smaller subgroup of non-parasitaemic patients receiving parasitaemic blood was the a-priori defined population to be assessed. Sufficient power was nevertheless maintained.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Goodrich, PhD | Terumo BCT Biotechnologies, LLC | (303) 231-4832 | ray.goodrich@terumobct.com |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Untreated Whole Blood | Biological | Transfusion with untreated fresh Whole Blood |
|
| immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion |
| Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
| Hematology Parameter in Patients - Hematocrit | Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 |
| Hematology Parameter in Patients - Total Hemoglobin | Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 |
| Hematology Parameter in Patients - Platelet Count | Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 |
| Hematology Parameter in Patients - Red Blood Cell (RBC) Count | RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 |
| Hematology Parameter in Patients - White Blood Cell (WBC) Count | WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3, 7, 28 |
| Biochemistry Parameter in Patients - Potassium | Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 |
| Coagulation Parameter in Patients - Prothrombin Time | Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 |
| Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 |
| Coagulation Parameter in Patients - International Normalized Ratio (INR) | INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Days 0, 1, 2, 3 |
| Death |
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| Lost to Follow-up |
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| Screen Failure or Became Inelegible |
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Transfusions with untreated whole blood
Untreated Whole Blood: Transfusion with fresh Whole Blood
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | meter |
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| Weight | Mean | Standard Deviation | kilogram |
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| Body Mass Index | Mean | Standard Deviation | kilogram/meter² |
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| OG001 | Control | Transfusions with untreated whole blood Untreated Whole Blood: Transfusion with fresh Whole Blood |
|
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| Secondary | Bacterial Contamination of Fresh Whole Blood (FWB) Products | Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject. Control products were only sampled post-collection, so no results for post-Mirasol treatment. All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment. All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Number | 95% Confidence Interval | percentage of blood product samples | immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion |
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| Secondary | Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit | Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | percentage | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin | Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | g/dL | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count | RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e12/L | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Hematology Parameter in Fresh Whole Blood Products - Platelet Count | Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e9/L | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count | WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e9/L | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Biochemistry Parameter in Fresh Whole Blood Products - Potassium | Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | mmol/L | Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion) |
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| Secondary | Hematology Parameter in Patients - Hematocrit | Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | percentage | Days 0, 1, 2, 3, 7, 28 |
|
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| Secondary | Hematology Parameter in Patients - Total Hemoglobin | Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | g/dL | Days 0, 1, 2, 3, 7, 28 |
|
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|
| Secondary | Hematology Parameter in Patients - Platelet Count | Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e9/L | Days 0, 1, 2, 3, 7, 28 |
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| Secondary | Hematology Parameter in Patients - Red Blood Cell (RBC) Count | RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e12/L | Days 0, 1, 2, 3, 7, 28 |
|
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| Secondary | Hematology Parameter in Patients - White Blood Cell (WBC) Count | WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | Cells x 10e9/L | Days 0, 1, 2, 3, 7, 28 |
|
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| Secondary | Biochemistry Parameter in Patients - Potassium | Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | mmol/L | Days 0, 1, 2, 3 |
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| Secondary | Coagulation Parameter in Patients - Prothrombin Time | Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | seconds | Days 0, 1, 2, 3 |
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| Secondary | Coagulation Parameter in Patients - Activated Partial Thromboplastin Time | Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | seconds | Days 0, 1, 2, 3 |
|
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| Secondary | Coagulation Parameter in Patients - International Normalized Ratio (INR) | INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency. | Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion | Posted | Mean | Standard Deviation | ratio | Days 0, 1, 2, 3 |
|
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|
| 13 |
| 111 |
| 33 |
| 111 |
| EG001 | Control | Transfusions with untreated whole blood Untreated Whole Blood: Transfusion with fresh Whole Blood | 9 | 112 | 37 | 112 |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Uraemic encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Pelvic abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| D000079426 |
| Vector Borne Diseases |
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