Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day

Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.

The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.

The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.

Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.

Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.

Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.

Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.

NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.

Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.