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Safety assessment data from the open-label extension of PedPRM treatment in pediatric patients with autism spectrum disorder. Adverse event profiles suggest the prolonged-release melatonin formulation maintained an acceptable safety profile over the extended study period.

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Figure 1

Study enrollment and participant flow for a long-term follow-up trial of prolonged-release melatonin (PedPRM) in children and adolescents with autism spectrum disorder and insomnia. The diagram tracks participants through screening, treatment phases, and follow-up periods.

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Figure 2

Efficacy outcomes showing changes in sleep parameters over the extended treatment period with pediatric prolonged-release melatonin in children with ASD. Long-term data indicate sustained improvements in sleep onset latency and total sleep time.

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Figure 4

Summary of sleep quality measures or caregiver-reported outcomes during long-term PedPRM administration in children with ASD and comorbid insomnia. Results suggest continued therapeutic benefit with nightly melatonin use.

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Figure 3

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Source Paper

Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder.

Journal of child and adolescent psychopharmacology (2018)

PMID: 30132686

DOI: 10.1089/cap.2018.0020

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![Figure 3: Safety assessment data from the open-label extension of PedPRM treatment in pediatric patients with autism spectrum disorder. Adverse event profiles suggest the prolonged-release melatonin formulation maintained an acceptable safety profile over the extended study period.](https://pdfs.citedhealth.com/figures/30132686/118.png)

> Source: Athanasios Maras et al. "Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insom." *Journal of child and adolescent psychopharmacology*, 2018. PMID: [30132686](https://pubmed.ncbi.nlm.nih.gov/30132686/)

<figure>
  <img src="https://pdfs.citedhealth.com/figures/30132686/118.png" alt="Safety assessment data from the open-label extension of PedPRM treatment in pediatric patients with autism spectrum disorder. Adverse event profiles suggest the prolonged-release melatonin formulation maintained an acceptable safety profile over the extended study period." />
  <figcaption>Figure 3. Safety assessment data from the open-label extension of PedPRM treatment in pediatric patients with autism spectrum disorder. Adverse event profiles suggest the prolonged-release melatonin formulation maintained an acceptable safety profile over the extended study period.<br>  Source: Athanasios Maras et al. "Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insom." <em>Journal of child and adolescent psychopharmacology</em>, 2018. PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/30132686/">30132686</a></figcaption>
</figure>

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