A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

Exclusion Criteria

• •The participant had any new condition or worsening of an existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participation or completion the study.
• •The participant, in the opinion of the investigator, was unable to adhere to the requirements of the study.
• •The participant was unwilling or unable to abstain from the use of alcohol for 1 day prior to and 3 days after each olipudase alfa infusion for the duration of the treatment period.
• •The participant was unwilling or unable to avoid, for 10 days before and 3 days after liver biopsies, medications or herbal supplements that are potentially hepatotoxic (only participants who previously participated in the DFI13412 study).
• •The participant required medication(s) that may decrease olipudase alfa activity (eg, fluoxetine, chlorpromazine; tricyclic antidepressants \[eg, imipramine, desipramine\]).
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.