AUC(0-14days) was calculated by a combination of linear and logarithmic trapezoidal methods and expressed in the unit of concentration × time. The linear trapezoidal method used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method used for those arising from decreasing concentrations. Plasma fibrinogen activity determined by the Clauss method in the central laboratory of the study. Pharmacokinetic (PK) parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

AUC(0-14days) was calculated by a combination of linear and logarithmic trapezoidal methods and expressed in the unit of concentration × time. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

AUC0-infinity was calculated as AUC0-t + Ct/Kel, where (AUC0-t) was the area under the concentration versus (vs) time curve from time 0 to the time of last quantifiable concentration (Ct), and Kel was the apparent terminal first-order elimination rate constant, determined by linear regression analysis of the natural log-linear segment of the plasma concentration-time curve, expressed in time^-1 units (1/h). Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

AUC0-infinity was calculated as AUC0-t + Ct/Kel, where (AUC0-t) was the area under the concentration vs. time curve from time 0 to the time of last quantifiable concentration (Ct), and Kel was the apparent terminal first-order elimination rate constant, determined by linear regression analysis of the natural log-linear segment of the plasma concentration-time curve, expressed in time^-1 units (1/h). Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Cmax was obtained directly from the experimental data without interpolation. Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Cmax was obtained directly from directly from the experimental data without interpolation. Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Tmax was obtained directly from the experimental data without interpolation, expressed in time units (hour). Plasma fibrinogen activity was determined by the Clauss method in the central laboratory of the study.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here, the 'number of participants analyzed' signifies participants who were evaluable for this outcome measure.

Tmax was obtained directly from the experimental data without interpolation, expressed in time units (hour). Plasma fibrinogen activity was determined by the ELISA method in the central laboratory of the study.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here, the 'number of participants analyzed' signifies participants who were evaluable for this outcome measure.

t1/2 was the time measured for the concentration to decrease by one half. t1/2 calculated by natural log 2 divided by Kel and expressed in time units (hour). PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

t1/2 was the time measured for the concentration to decrease by one half. t1/2 calculated by natural log 2 divided by Kel and expressed in time units (hour). PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

MRT was calculated by AUC0-inf/AUC0-inf - (T1/2), where AUC0-inf was the area under the first moment of the concentration vs. time curve from time 0 extrapolated to infinite time and T1/2 was the apparent terminal half-life of infusion. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

MRT was calculated by AUC0-inf/AUC0-inf - (T1/2), where AUC0-inf was the area under the first moment of the concentration vs. time curve from time 0 extrapolated to infinite time and T1/2 was the apparent terminal half life of infusion.PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. PK parameters adjusted for baseline fibrinogen level calculated by deducting the pre-infusion fibrinogen concentration from the post-infusion concentrations before the calculation.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Incremental IVR was calculated for fibrinogen levels from the peak level recorded within and included the first four hours after the end of infusion and reported as milligram per deciliter per milligram per kilogram [mg/dL]/[mg/kg]. IVR was determined for every participants using the following formula: ([FIB max (mg/dL)] - [FIB pre-infusion (mg/dL)])/FIB administered (mg)/Body weight (kg), where the FIB max is the peak FIB activity within the first four hours after the end of infusion and FIB pre-infusion was the baseline FIB activity level of the participant. FIB administered was the actual administered dose calculated using the actual volume administered to the participant, the declared potency, and the true concentration of FIB in the batch used.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Incremental IVR was calculated for fibrinogen levels from the peak level recorded within and included the first four hours after the end of infusion and reported as milligram per deciliter per milligram per kilogram [mg/dL]/[mg/kg]. IVR was determined for every participants using the following formula: ([FIB max (mg/dL)] - [FIB pre-infusion (mg/dL)])/FIB administered (mg)/Body weight (kg), where the FIB max is the peak FIB activity within the first four hours after the end of infusion and FIB pre-infusion was the baseline FIB activity level of the participants. FIB administered was the actual administered dose calculated using the actual volume administered to the participants, the declared potency, and the true concentration of FIB in the batch used.

The PK analysis population included all participants who had received study medication and had sufficient fibrinogen plasma concentration data to facilitate calculation of pharmacokinetic parameters. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

MCF was as a functional parameter of blood's ability to coagulate, provides an indirect measure of hemostatic efficacy of replacement treatment with fibrinogen concentrates in participants with fibrinogen deficiency. Rotational thromboelastography (ROTEM) was performed on frozen plasma samples by the central laboratory to measure MCF. Undetectable MCF values were set to 0.

The Evaluable population included all participants who received Investigational Product (IP) at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Difference in adult participants plasma samples in CT from baseline to 1-hour post-infusion indicated the hemostatic efficacy of the treatment with fibrinogen concentrate in participants with fibrinogen deficiency.

The Evaluable population included participants who received investigational product at any amount and who had at least 2 measurements pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

CFT value in participants plasma samples in CFT at 1-hour post-infusion indicated the hemostatic efficacy of the treatment with fibrinogen concentrate in participants with fibrinogen deficiency.

Evaluable population included participants who received investigational product at any amount and who had at least 2 measurements pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure at specified timepoint.

Difference in participants plasma samples in alpha angle from baseline to 1-hour post-infusion indicated the hemostatic efficacy of the treatment with fibrinogen concentrate in participants with fibrinogen deficiency.

The Evaluable population included all participants who received at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Difference in the participants plasma samples standard coagulation tests from baseline to 1-hour post-infusion indicated hemostatic efficacy of the treatment with fibrinogen concentrate in participants with fibrinogen deficiency.

The Evaluable population included all participants who received at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure at specified timepoint.

Difference in the participants plasma samples standard coagulation tests from baseline to 1-hour post-infusion indicated hemostatic efficacy of the treatment with fibrinogen concentrate in participants with fibrinogen deficiency.

The Evaluable population included all participants who received at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure at specified timepoint.

Difference in participants plasma samples standard coagulation tests from baseline to 1-hour post-infusion indicated hemostatic efficacy of the treatment with a fibrinogen concentrate in participants with fibrinogen deficiency.

The Evaluable population included all participants who received at any amount and who had at least two measurements, pre-infusion MCF and 1-hour post-infusion MCF measurements by ROTEM. Here 'N' (overall number of participants analyzed) signifies participants who were evaluable for this outcome measure at specified timepoint.

An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. SAE was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participants hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Treatment-emergent defined as adverse events/serious adverse events that started or worsened on or after the start of the investigational product infusion.

The Safety population included all participants who received infusion (at any dose) of the IP.