A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis
is that treatment of RSV-infected infants/children with lumicitabine (also known as
JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo
(looks like lumicitabine). The participants who have completed treatment course
(lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the
treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this
study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in
infants/children with a history of RSV infection. The participants will be assessed via
monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.

Inclusion Criteria:

- Male or female infants and children who were previously randomized in study
64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and
who completed the planned course of the study drug and the last study-related visit of
study 64041575RSV2004

- The participant's legally acceptable representative must sign an informed consent form
(ICF) indicating that he or she understands the purpose of, and procedures required
for, the study and is willing for the participant to participate in the study

Exclusion Criteria:

- The participants legally acceptable representative, i.e, parent/legal
guardian/caregiver, is not able to maintain reliable communication with the
investigator

- Any condition for which, in the opinion of the investigator, participation would not
be in the best interest of the participant (example, compromise the well-being) or
that could prevent, limit, or confound the protocol-specified assessments