A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy

Exclusion Criteria

• •Previous or current enrolment in investigational study prior to initiation of study treatment
• •Any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information
• •Concomitant or previous administration of an SMN2-targeting antisense oligonucleotide
• •Concomitant or previous use of an anti-myostatin agent
• •Participants requiring invasive ventilation or tracheostomy
• •Participants requiring awake non-invasive ventilation or with awake hypoxemia (Arterial Oxygen Saturation \[SaO2\] \<95%) with or without ventilator support
• •Presence of feeding tube and an OrSAT score of 0
• •Hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening
• •Any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.