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AEs that occurred during the core study are reported elsewhere.
Details of exclusion criteria for the core study are provided elsewhere [ 22].
Ongoing events at the end of the core study are counted again in the extension studies; therefore, patients may be counted twice in the total columns for the core and extension studies.
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Patient disposition for the core study was described in the core study manuscript [ 22].
The study design of the core study is described elsewhere [ 22].
The same pooled sites created in the core study were used in this study.
The core study was funded by the National Health and Medical Research Council (NHMRC) of Australia.
Patients completing this 1-year core study were eligible to enter a 4-year extension.
No comparisons among the initially randomized groups in the core study were performed in this extension study.
In addition, our core study is expanded by a comprehensive neurobiological and psychosocial assessment to explore potential underlying mechanisms.
Notably, only patients who remained on their randomized medication at the end of the core study were included.
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