The pharmacokinetic analysis set (PKAS) included all randomized participants who received at least 1 dose of OM and had at least 1 evaluable OM PK parameter.

Pharmacokinetic analysis set

Pharmacokinetic analysis set

Pharmacokinetic analysis set

Pharmacokinetic analysis set with available data at each time point.

Pharmacokinetic analysis set with available data at each time point.

Systolic ejection time was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

Stroke volume was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

LVESD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

LVEDD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

Heart rate was measured using electrocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.

The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.

Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE.

A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:

• fatal
• life threatening
• required in-patient hospitalization or prolongation of existing hospitalization
• resulted in persistent or significant disability/incapacity
• congenital anomaly/birth defect
• other medically important serious event

Participants randomized in the dose-escalation phase who received at least 1 dose of study drug.

An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.

Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE.

A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria:

• fatal
• life threatening
• required in-patient hospitalization or prolongation of existing hospitalization
• resulted in persistent or significant disability/incapacity
• congenital anomaly/birth defect
• other medically important serious event

All participants randomized in the expansion phase who received at least 1 dose of study drug.