The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.

Only the first event was counted.

The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.

Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.

The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted.

The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.

For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.

The analysis was performed on the same population as previously (i.e. exposed population).