An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.

Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to <60 x10^4 platelet/mcrL beyond 3 months after the start of study drug administration.

Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.

Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to <40 x10^4 platelets/mcrL beyond 3 months after the start of study drug administration.

Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.

Participants who achieved at least 50% reduction in platelet count from their baseline during the 1-year observation period was assessed.

Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.