The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.

Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.

The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. "Preventative dose" was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and "additional dose" was defined as a dose taken beyond the need to control hemostasis.

The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.

The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.

The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.

The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.

Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator's discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject's bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.