Please assess the completion status of the following clinical trial:

Trial Title: Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: DOUBLE
- Phase: PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~To be eligible for study entry, all patients must satisfy all of the following criteria at screening:~1. Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug~2. Must have written informed consent provided by a legal guardian and assent (if needed)~3. Must have a documented history of ASD according to or consistent with the ICD-10 (International Classification of Diseases) or DSM-5/4 (Diagnostic and Statistical Manual of Mental Disorders) criteria, or neurodevelopmental disabilities caused by neurogenetic diseases (i.e., Smith-Magenis syndrome, Angelman syndrome, Bourneville's disease \[tuberous sclerosis\]) as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.~4. Must have current sleep problems including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND/OR ≥0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)~5. May be on a stable dose of non-excluded medication for 3 months, including anti- epileptics, anti-depressants (selective serotonin reuptake inhibitors \[SSRIs\]), stimulants, all mood changing drugs and β-blockers. (Only morning administration of β-blockers is allowed since β-blockers at night have the potential to reduce endogenous melatonin levels and might cause disturbed sleep)~6. The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, stimulants, etc.~After completing 4 weeks of sleep hygiene training (for those who need it) and 2 weeks of placebo run-in, patients will be eligible to continue the study if they comply with the following:~* Continue to fulfill sleep problem criteria (see Inclusion Criterion 4) based on the completed Sleep and Nap Diary entered into the electronic case report form~* Parents demonstrate compliance in Sleep and Nap Diary completion (5 out of 7 nights). Compliance means that in at least 5 out of 7 nights per week (total of 2 weeks before each scheduled visit) the parents complete the diary pages with all mandatory questions~* Continue to fulfil all other eligibility criteria~Exclusion Criteria:~Children who meet any of the following criteria will be excluded from participating in the study:~1. Have had treatment with any form of melatonin within 2 weeks prior to Visit 1~2. Have a known allergy to melatonin or lactose~3. Have a known moderate to severe sleep apnea~4. Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances~5. Did not respond to previous Circadin® therapy based on past medical history records in the last 2 years~6. Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1 (Section 7.1)~7. Are females of child-bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)~8. Pregnant females~9. Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study \[this does not include patients who participated in the Phase I Pharmacokinetics (PK) study who can be already included in the study\]~10. Children with known renal or hepatic insufficiency

- Gender: ALL
- Minimum Age: 2 Years
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Circadin 2/5/10 mg (Type: ACTIVE_COMPARATOR): Active arm
- Placebo (Type: PLACEBO_COMPARATOR): Placebo arm

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete