any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to: aspartate aminotransferase (ast) or alanine aminotransferase (alt) >3 × the upper limit of normal (uln) at screening. total bilirubin or alkaline phosphatase level >3.0 × the uln at screening. platelet count <100 × 109/l. extracorporeal membrane oxygenation required at baseline. stage 3 or end stage renal disease (esrd) patients with acute renal insufficiency may be considered only after discussion with medical monitor. is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy). pregnant (patient has a positive pregnancy test result at screening) or breast-feeding. anticipated discharge from the hospital or transfer to another hospital which is not a study site. allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin. patient must agree to refrain from taking oral aspirin or any orally administered acetylsalicylic acid medications until pk sampling is completed to be eligible to participate in the pk sub-study.

any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to: aspartate aminotransferase (ast) or alanine aminotransferase (alt) >3 × the upper limit of normal (uln) at screening. total bilirubin or alkaline phosphatase level >3.0 × the uln at screening. platelet count <100 × 109/l. extracorporeal membrane oxygenation required at baseline. stage 3 or end stage renal disease (esrd) patients with acute renal insufficiency may be considered only after discussion with medical monitor. is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy). pregnant (patient has a positive pregnancy test result at screening) or breast-feeding. anticipated discharge from the hospital or transfer to another hospital which is not a study site. allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin. patient must agree to refrain from taking oral aspirin or any orally administered acetylsalicylic acid medications until pk sampling is completed to be eligible to participate in the pk sub-study.

any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to: aspartate aminotransferase (ast) or alanine aminotransferase (alt) >3 × the upper limit of normal (uln) at screening. total bilirubin or alkaline phosphatase level >3.0 × the uln at screening. platelet count <100 × 109/l. extracorporeal membrane oxygenation required at baseline. higher than grade 2 end stage renal disease (esrd) patients with acute renal insufficiency may be considered only after discussion with medical monitor. is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy). pregnant (patient has a positive pregnancy test result at screening) or breast-feeding. anticipated discharge from the hospital or transfer to another hospital which is not a study site. allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin. patient must agree to refrain from taking oral aspirin or any orally administered acetylsalicylic acid medications until pk sampling is completed to be eligible to participate in the pk sub-study.

any condition, including any significant medical or neuropsychiatric condition, including the presence of laboratory abnormalities, which in the judgment of the investigator places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study including, but not limited to: aspartate aminotransferase (ast) or alanine aminotransferase (alt) >3 × the upper limit of normal (uln) at screening. total bilirubin or alkaline phosphatase level >3.0 × the uln at screening. platelet count <100 × 109/l. extracorporeal membrane oxygenation required at baseline. higher than grade 2 end stage renal disease (esrd) patients with acute renal insufficiency may be considered only after discussion with medical monitor. is at increased risk for bleeding events (e.g., had recent cerebral hemorrhage, gastrointestinal bleeding, serious trauma, recent surgery, or organ biopsy). pregnant (patient has a positive pregnancy test result at screening) or breast-feeding. anticipated discharge from the hospital or transfer to another hospital which is not a study site. allergy to any study medication or known allergy to nonsteroidal anti-inflammatory drugs, including aspirin. patient must agree to refrain from taking oral aspirin or any orally administered acetylsalicylic acid medications until pk sampling is completed to be eligible to participate in the pk sub-study.