Physiologic solution administered at 0.25 mL/kg/hour

Daily insulin is reported as IU/kg and intake averaged over the previous week.

Daily insulin is reported as IU/kg and intake averaged over the previous week.

Data of this outcome are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=42; 46
• 30 min; N=40; 46
• 60 min; N=40; 46
• 90 min; N=40; 46
• 120 min; N=41; 46
• 180 min; N=40; 46
• 240 min; N=39; 44

Data are reported as "model estimates over all timepoints"

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 42 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 41

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=44; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=42; 47
• 90 min; N=42; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=33; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=33; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 40
• 240 min; N=33; 41

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=41; 47
• 90 min; N=41; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal)
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 40

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for:

• fasting plasma glucose,
• HbA1c,
• stimulated C-peptide
• insulin requirement subscales. The higher the total score, the better the outcome.
• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for glucose, HbA1c, stimulated C-peptide and insulin requirement subscales.

The higher the total score the better the outcome.

• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

Percentage of patients with a glycated haemoglobin (HbA1c) <6.5% at day 365±14 after the transplant.

A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

Percentage of patients with an HbA1c <6.5% at day 365±14 after the transplant AND free of severe hypoglycemic events from day 75±14 to day 365±14 after the transplant inclusive.A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

The percentages of patients with any treatment emergent adverse events (TEAE, serious and non serious) and with serious TEAE by severity are presented.

Patients with multiple events within a particular system organ class or preferred term were counted only under the category of their most severe event within that system organ class or preferred term.

A serious AE was defined as any untoward medical occurrence that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event)
• Required inpatient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was a congenital anomaly/birth defect
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

The following definition applies:

- Asymptomatic hypoglycemia = An event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <70mg/dL.

The following definition applies:

- Documented symptomatic hypoglycemia = An event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <70mg/dL.

A diabetic ketoacidosis event is defined as the presence of:

• hyperglycemia (blood glucose >200 mg/dL);
• pH <7.3 or HCO3 <15;
• ketones positive in the serum or urine.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

The time-to-peak value in minutes was computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test Case Report Form.

The time to peak value in minutes will be computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test CRF.

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called "Adverse reactions" (ADR).

An adverse reaction is defined as any untoward medical occurrence in a patient or clinical investigation patient, which has a causal relationship with the administered medicinal product.

Serious Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called serious "Adverse reactions".

A serious adverse reaction is defined as any untoward medical occurrence with a causal relationship with the administered medicinal product, that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)
• Required patient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

Total of all reporting groups

AUC for the serum C-peptide level is calculated during the first 4 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

AUC for the serum C-peptide level is calculated during the first 4 hours of a mixed meal tolerance test (MMTT), normalized by the number of Islet Equivalent (IEQ)/kg

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

Daily insulin is reported as IU/kg and intake averaged over the previous week.

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Daily insulin is reported as IU/kg and intake averaged over the previous week.

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Data of this outcome are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=42; 46
• 30 min; N=40; 46
• 60 min; N=40; 46
• 90 min; N=40; 46
• 120 min; N=41; 46
• 180 min; N=40; 46
• 240 min; N=39; 44

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

Data are reported as "model estimates over all timepoints"

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 42 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 41

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=44; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=42; 47
• 90 min; N=42; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=33; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=33; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 40
• 240 min; N=33; 41

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
• 15 min; N=43; 47
• 30 min; N=41; 47
• 60 min; N=41; 47
• 90 min; N=41; 47
• 120 min; N=42; 47
• 180 min; N=41; 47
• 240 min; N=40; 44

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• basal; N=34; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal)
• 15 min; N=34; 41
• 30 min; N=34; 41
• 60 min; N=34; 41
• 90 min; N=34; 41
• 120 min; N=34; 41
• 180 min; N=33; 41
• 240 min; N=33; 40

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for:

• fasting plasma glucose,
• HbA1c,
• stimulated C-peptide
• insulin requirement subscales. The higher the total score, the better the outcome.
• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for glucose, HbA1c, stimulated C-peptide and insulin requirement subscales.

The higher the total score the better the outcome.

• Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
• HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
• Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
• Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Percentage of patients with a glycated haemoglobin (HbA1c) <6.5% at day 365±14 after the transplant.

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Percentage of patients with an HbA1c <6.5% at day 365±14 after the transplant AND free of severe hypoglycemic events from day 75±14 to day 365±14 after the transplant inclusive.A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

The percentages of patients with any treatment emergent adverse events (TEAE, serious and non serious) and with serious TEAE by severity are presented.

Patients with multiple events within a particular system organ class or preferred term were counted only under the category of their most severe event within that system organ class or preferred term.

A serious AE was defined as any untoward medical occurrence that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event)
• Required inpatient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was a congenital anomaly/birth defect
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Malnutrition risk levels are defined as:

• Poor prognosis = pre-albumin level <5.0 mg/dL
• Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
• Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
• Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

• No steatorrhea;
• Steatorrhea few times per week;
• Steatorrhea daily;
• Stool incontinence.

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

The following definition applies:

- Asymptomatic hypoglycemia = An event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <70mg/dL.

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

The following definition applies:

- Documented symptomatic hypoglycemia = An event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <70mg/dL.

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

A diabetic ketoacidosis event is defined as the presence of:

• hyperglycemia (blood glucose >200 mg/dL);
• pH <7.3 or HCO3 <15;
• ketones positive in the serum or urine.

Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

ITT population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.

ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

The time-to-peak value in minutes was computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test Case Report Form.

ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

The time to peak value in minutes will be computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test CRF.

ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Safety Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

• baseline; N=50; 52
• Day 2 post-transplant; N=49; 51
• Day 3 post-transplant; N=47; 50
• Day 7 post-transplant; N=47; 50
• Day 75 post-transplant; N=44; 47

Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.

Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called "Adverse reactions" (ADR).

An adverse reaction is defined as any untoward medical occurrence in a patient or clinical investigation patient, which has a causal relationship with the administered medicinal product.

Safety Population:Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.

Serious Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called serious "Adverse reactions".

A serious adverse reaction is defined as any untoward medical occurrence with a causal relationship with the administered medicinal product, that at any dose:

• Resulted in death
• Was life-threatening (ie, the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)
• Required patient hospitalization or prolongation of existing hospitalization
• Resulted in persistent or significant disability/incapacity
• Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above

Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population were based on treatment received. Patients randomized but not treated were analyzed in the total summary statistics only.

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour