The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview. The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity

The intent-to-treat (ITT) analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale. Each of the CGI-TS-Improvement response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.

The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

A TTS responder is defined, on a per-visit basis, as a participant whose TTS value is reduced by at least 30% from baseline at the specified postbaseline visit.

Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

The YGTSS Impairment item is used to rate impairment due to tics using the following 50-point anchored scale: 0 = None; 10 = Minimal; 20 = Mild; 30 = Moderate; 40 = Marked; 50 = Severe.

The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

The YGTSS Global Tic Severity score is the sum of the YGTSS TTS and the YGTSS Impairment score and ranges from 0 to 100, with higher scores representing greater severity.

The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

A modified RTRS was used in this study that includes short video recordings to measure 5 tic variables: number of body areas affected, frequency of motor and phonic tics, and severity of motor and phonic tics. The RTRS total score is calculated as the sum of the 5 domain scores, and ranges from 0 to 20, with higher scores representing greater severity. The final on-treatment visit was used in participants who discontinued prior to Week 6.

Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

The PUTS is an instrument for quantifying the premonitory urge phenomena associated with tics. It consists of 9 items, each of which is scored on a 4-point scale (1=not at all true, 2=a little true, 3=pretty much true, 4=very much true). The PUTS total score is calculated as the sum of the scores for the 9 items. The total score ranges from 9 to 36, with higher scores indicating a worse outcome.

The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Excludes those with missing PUTS data. Dose levels based on age group were prespecified to be combined within each dose arm.

The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale. Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient.

The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.

A participant is classified as a CGI-TS-Improvement responder at a given visit if their CGI-TS-Improvement score is either a "1" ("very much improved") or a "2" ("much improved") at the visit.

Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.