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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

3. Key inclusion and exclusion criteria.

Criteria Number of trials Trials
Inclusion criteria of special interest
A diagnosis of ODD or CD or disruptive behavior disorder 4 Brown 1991; Bukstein 1998; Connor 2000; Gadow 1990
A diagnosis of bipolar disorder and treated with a stable dose of mood stabilisers or either bipolar disorder or borderline disorder 2 Findling 2007; Zeni 2009
A diagnosis of Tourette's syndrome or motor tic disorder 5 Castellanos 1997; Gadow 1995; Gadow 2007; Gadow 2011; Tourette's Syndrome Study Group 2002
A diagnosis of developmental co‐ordination disorder 2 Flapper 2008; Soleimani 2017
A diagnosis of epilepsy 1 Gonzalez‐Heydrich 2010
A diagnosis of velocardiofacial syndrome 1 Green 2011
A diagnosis of cerebral palsy 1 Symons 2007
Non‐nicotine substance use disorder 2 Riggs 2011; Szobot 2008
Positive response to methylphenidate prior to screening or being on a stable dose of methylphenidate before screening/entering trial or familiar with methylphenidate intake for at least 2 weeks‐2 years 27 Childress 2017; Childress 2020b; Cox 2006; Döpfner 2004; Findling 2006; Findling 2008; Kortekaas‐Rijlaarsdam 2017; Lijffijt 2006; Matthijssen 2019; Muniz 2008; Nikles 2006; Pelham 2001a; Pelham 2011; Pliszka 2017; Samuels 2006; Schulz 2010; Silva 2005a; Silva 2006; Silva 2008; Swanson 1998; Swanson 1999; Swanson 2002a; Swanson 2002b; Swanson 2004b; Tannock 2018; Wigal 2003; Wilkison 1995
Most common exclusion criteria and exclusion criteria of special interest
Intellectual disability, or estimated/measured IQ < 60‐85, or deemed by investigators to have below‐average cognitive capacity, or history of neurological impairment, or history of significant developmental delay, or to be home‐schooled, or intellectual disability 126 Ahmann 1993; Barkley 1989b; Barkley 1991; Barragán 2017; Bedard 2008; Bhat 2020; Blum 2011; Brams 2008; Brams 2012; Brown 1984a; Brown 1988; Brown 1991; Butter 1983; Carlson 1995; Carlson 2007; Castellanos 1997; Childress 2009; Childress 2017; Childress 2020a; Childress 2020b; Coghill 2007; Coghill 2013; Cook 1993; Corkum 2008; Corkum 2020; Döpfner 2004; Douglas 1995; DuPaul 1996; Duric 2012; Epstein 2011; Findling 2006; Findling 2007; Findling 2008; Findling 2010; Fine 1993; Firestone 1981; Flapper 2008; Forness 1992; Froehlich 2011; Froehlich 2018; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Gonzalez‐Heydrich 2010; Gorman 2006; Greenhill 2002; Gruber 2007; Hale 2011; Heriot 2008; Horn 1991; Huang 2021; Ialongo 1994; Jensen 1999 (MTA); Kelly 1989; Klorman 1990; Kollins 2006 (PATS); Kollins 2021; Konrad 2004; Kortekaas‐Rijlaarsdam 2017; Leddy 2009; Lehmkuhl 2002; Lufi 1997; Martins 2004; Matthijssen 2019; McCracken 2016; McGough 2006; McInnes 2007; Murray 2011; NCT00409708; NCT02039908; NCT02293655; NCT02536105; Oesterheld 1998; Palumbo 2008; Pearson 2013; Pelham 1989; Pelham 2001a; Pelham 2011; Pelham 2014; Pliszka 2007; Pliszka 2017; Quinn 2004; Ramtvedt 2013; Reitman 2001; Rubinsten 2008; Schachar 2008; Schrantee 2016; Schwartz 2004; Sharp 1999; Shiels 2009; Silva 2005a; Silva 2008; Smith 1998; Smithee 1998; Solanto 2009; Soleimani 2017; Stein 1996; Stein 2003; Stein 2011; Sunohara 1999; Swanson 1998; Swanson 2004b; Szobot 2004; Tannock 1992; Tannock 1993; Tannock 1995a; Tannock 1995b; Tannock 2018; Taylor 1987; Taylor 1993; Tourette's Syndrome Study Group 2002; Tucker 2009; Van der Meere 1999a; Waxmonsky 2008; Weiss 2021; Wigal 2004; Wigal 2011; Wigal 2013; Wigal 2014; Wigal 2015; Wilens 2008; Wilens 2010; Wolraich 2001; Zeiner 1999; Zeni 2009
Learning disability, or not having an age‐appropriate academic level, or at least an average learning score 17 Abikoff 2009; Biederman 2003b; Childress 2009; Coghill 2007; Cook 1993; CRIT124US02; Froehlich 2018; Greenhill 2006; Moshe 2012a; Muniz 2008; Murray 2011; NCT02293655; Pelham 2001a; Pliszka 2007; Rubinsten 2008; Wigal 2011; Wilkison 1995
Any psychiatric disorder that could contraindicate treatment or confound efficacy or safety assessments, or any psychiatric comorbidity, or any concurrent significant psychiatric illness, or any psychiatric disorder with few specified exceptions, or any comorbid axis I psychiatric disorder requiring treatment, or any psychiatric comorbidity requiring treatment 54 Biederman 2003b; Borcherding 1990; Brams 2008; Brams 2012; Carlson 2007; Castellanos 1997b; Childress 2020c; Corkum 2008; Corkum 2020; Duric 2012; Findling 2006; Findling 2008; Findling 2010; Flapper 2008; NCT02039908; Greenhill 2002; Greenhill 2006; Jacobi‐Polishook 2009; Kollins 2006 (PATS); Konrad 2004; Kortekaas‐Rijlaarsdam 2017; Lopez 2003; Lufi 1997; Matthijssen 2019; McGough 2006; Moshe 2012; Muniz 2008; Murray 2011; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Pelham 2011; Perez‐Alvarez 2009; Pliszka 2017; Quinn 2004; Schachar 2008; Schrantee 2016; Schulz 2010; Silva 2005a; Silva 2006; Silva 2008; Soleimani 2017; Swanson 1998; Szobot 2008; Taylor 1987; Waxmonsky 2008; Weiss 2021; Wigal 2013; Wigal 2014; Wigal 2015; Wigal 2017; Wilens 2006b; Wilens 2010; Wilkison 1995
Psychiatric disorders that might be the primary cause of ADHD symptoms 2 Froehlich 2011; Wodrich 1998
Significant neurological history, or other significant CNS disorders, or gross sensory or motor deficits/impairment, or brain damage/traumatic brain injury, or head injury requiring hospitalisation, or major organic brain dysfunction, or history of electroencephalographic abnormalities 74 Ahmann 1993; Arnold 2004; Barkley 1989b; Barkley 2000; Barragán 2017; Bedard 2008; Blum 2011; Borcherding 1990; Brown 1984a; Brown 1985; Brown 1988; Brown 1991; Castellanos 1997; Childress 2020c; Coghill 2007; Cook 1993; Corkum 2008; Corkum 2020; Douglas 1986; DuPaul 1996; Duric 2012; Findling 2007; Firestone 1981; Froehlich 2011; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Gorman 2006; Hale 2011; Hawk 2018; Heriot 2008; Jacobi‐Polishook 2009; Jensen 1999 (MTA); Kelly 1989; Klorman 1990; Kortekaas‐Rijlaarsdam 2017; Leddy 2009; Lin 2014; Martins 2004; Moshe 2012; Murray 2011; Musten 1997; NCT02293655; Oesterheld 1998; Pearson 2013; Pelham 1989; Pliszka 2007; Quinn 2004; Ramtvedt 2013; Rapport 1985; Rapport 1987; Rapport 2008; Schachar 2008; Schrantee 2016; Sharp 1999; Shiels 2009; Smithee 1998; Solanto 2009; Soleimani 2017; Sumner 2010; Szobot 2004; Tannock 1989; Tannock 1992; Tannock 1993; Tannock 1995a; Tannock 1995b; Tannock 2018; Tirosh 1993a; Tirosh 1993b; Waxmonsky 2008; Weiss 2021; Wigal 2004; Zeiner 1999
History of epilepsy or seizures 60 Ahmann 1993; Barkley 1989b; Barragán 2017; Blum 2011; Brams 2008; Brams 2012; Carlson 2007; Childress 2009; Childress 2020a; Childress 2020b; Childress 2020c; Coghill 2013; Cook 1993; Corkum 2008; Corkum 2020; DuPaul 1996; Findling 2008; Findling 2010; Firestone 1981; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Greenhill 2002; Greenhill 2006; Hale 2011; Hawk 2018; Huang 2021; Leddy 2009; Lehmkuhl 2002; Lin 2014; McGough 2006; Moshe 2012; Muniz 2008; NCT00409708; NCT02536105; NCT02293655; Newcorn 2008; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Oesterheld 1998; Pliszka 2017; Ramtvedt 2013; Schrantee 2016; Sharp 1999; Shiels 2009; Soleimani 2017; Stein 2003; Swanson 2004b; Tannock 1989; Tucker 2009; Waxmonsky 2008; Weiss 2021; Wigal 2003; Wigal 2011; Wigal 2013; Wigal 2015; Wigal 2017; Wilens 2006b; Wilens 2010; Wolraich 2001
History or diagnosis of and/or family history of Tourette's syndrome or tic disorders 62 Ahmann 1993; Abikoff 2009; Barkley 1989b; Barkley 1991; Barkley 2000; Bhat 2020; Blum 2011; Borcherding 1990; Brams 2008; Brams 2012; Buitelaar 1995; Childress 2009; Childress 2020a; Childress 2020b; Childress 2020c; Coghill 2013; DuPaul 1996; Findling 2008; Fine 1993; Greenhill 2002; Gruber 2007; Heriot 2008; Huang 2021; Jensen 1999 (MTA); Kent 1995; Kollins 2006 (PATS); Kollins 2021; Lehmkuhl 2002; Lin 2014; McCracken 2016; McGough 2006; Moshe 2012; Muniz 2008; Murray 2011; NCT02536105; Newcorn 2008; Overtoom 2003; Palumbo 2008; Pearson 2013; Pliszka 2000; Pliszka 2017; Riggs 2011; Schachar 1997a; Schrantee 2016; Schwartz 2004; Silva 2005a; Silva 2006; Silva 2008; Solanto 2009; Stein 2003; Stein 2011; Sumner 2010; Swanson 2004b; Tannock 1989; Wigal 2003; Wigal 2004; Wigal 2011; Wigal 2013; Wigal 2017; Wilens 2006b; Wilens 2010; Wolraich 2001
History or diagnosis of autism or pervasive development disorder or Asperger's disorder 49 Abikoff 2009; Barkley 1989b; Barragán 2017; Bhat 2020; Blum 2011; Buitelaar 1995; Carlson 2007; Corkum 2008; Döpfner 2004; DuPaul 1996; Findling 2007; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Gorman 2006; Gruber 2007; Hawk 2018; Heriot 2008; Kent 1999; Klorman 1990; Kollins 2006 (PATS); Kollins 2021; Konrad 2005; Kritchman 2019; Leddy 2009; Lehmkuhl 2002; Lin 2014; McCracken 2016; Murray 2011; Musten 1997; NCT02039908; Newcorn 2008; Overtoom 2003; Palumbo 2008; Pearson 2013; Schachar 2008; Schwartz 2004; Shiels 2009; Stein 1996; Stein 2011; Taylor 1987; Tourette's Syndrome Study Group 2002; Van der Meere 1999a; Waxmonsky 2008; Wigal 2004; Wigal 2011; Zeiner 1999; Zeni 2009
History or diagnosis of and/or family history of: major depression or depressive disorder or bipolar disorder or affective disorder or mood disorder 45 Abikoff 2009; Barkley 1989b; Blum 2011; Carlson 1995c; Carlson 2007; Childress 2020b; Döpfner 2004; Findling 2007; Gonzalez‐Heydrich 2010; Gorman 2006; Horn 1991; Ialongo 1994; Kent 1995; Kollins 2006 (PATS); Kollins 2021; Kritchman 2019; Lehmkuhl 2002; Lin 2014; Martins 2004; McCracken 2016; Murray 2011; NCT02293655; Newcorn 2008; Oesterheld 1998; Palumbo 2008; Pearson 2013; Pliszka 1990; Pliszka 2000; Riggs 2011; Schachar 1997a; Solanto 2009; Stein 2003; Stein 2011; Sumner 2010; Swanson 2002a; Szobot 2004; Tourette's Syndrome Study Group 2002; Tucker 2009; Waxmonsky 2008; Wigal 2003; Wigal 2004; Wigal 2011; Wilens 2006b; Wilens 2010; Zeiner 1999
History or diagnosis of eating disorder 9 Childress 2020b; Kritchman 2019; Murray 2011; Palumbo 2008; Tourette's Syndrome Study Group 2002; Waxmonsky 2008; Wigal 2004; Wigal 2011; Wilens 2006b
Diagnosis of post‐traumatic stress disorder 1 Abikoff 2009
History or diagnosis of obsessive‐compulsive disorder 8 Abikoff 2009; Blum 2011; Childress 2009; Jensen 1999 (MTA); Kollins 2021; Murray 2011; Wigal 2004; Wigal 2011
Diagnosis of panic disorder, or severe anxiety disorder, or in the investigator's evaluation very anxious, tense or agitated, or separation anxiety disorder 23 Abikoff 2009; Barkley 1989b; Childress 2020b; Döpfner 2004; Horn 1991; Huang 2021; Ialongo 1994; Kent 1995; Kritchman 2019; Lehmkuhl 2002; Lin 2014; McCracken 2016; Murray 2011; Newcorn 2008; Schachar 1997a; Sumner 2010; Sunohara 1999; Swanson 2002a; Tannock 1995a; Tucker 2009; Wigal 2003; Wigal 2011; Wilens 2006b
History or diagnosis of CD/behaviour disorder 11 Childress 2020b; Coghill 2013; Kollins 2021; Murray 2011; Sunohara 1999; Swanson 2002a; Tannock 1989; Tannock 1992; Wigal 2003; Wigal 2011; Wilens 2008
History or diagnosis of ODD 2 Swanson 2002a; Wigal 2003
Lifetime history of psychosis or thought disturbance or thought disorder or schizoid, schizotypal or frank psychotic features 66 Abikoff 2009; Barkley 1989b; Bedard 2008; Bhat 2020; Blum 2011; Brown 1985; Brown 1991; Childress 2009; Childress 2020b; Cook 1993; Döpfner 2004; Douglas 1986; DuPaul 1996; Findling 2007; Firestone 1981; Froehlich 2018; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Gonzalez‐Heydrich 2010; Gorman 2006; Gruber 2007; Hawk 2018; Heriot 2008; Horn 1991; Huang 2021; Ialongo 1994; Kaplan 1990; Kelly 1989; Kent 1995; Klorman 1990; Kollins 2006 (PATS); Kollins 2021; Kritchman 2019; Leddy 2009; Lehmkuhl 2002; Lin 2014; McCracken 2016; Murray 2011; NCT02293655; Newcorn 2008; Palumbo 2008; Pliszka 1990; Pliszka 2000; Ramtvedt 2013; Riggs 2011; Schachar 2008; Schrantee 2016; Schwartz 2004; Shiels 2009; Smithee 1998; Solanto 2009; Stein 2011; Sumner 2010; Tannock 1993; Tourette's Syndrome Study Group 2002; Tucker 2009; Waxmonsky 2008; Wigal 2003; Wigal 2004; Wigal 2011; Wilens 2006b; Wolraich 2001; Zeiner 1999; Zeni 2009
Lifetime history or diagnosis of mania or hypomania 7 Abikoff 2009; Findling 2007; Froehlich 2011; Froehlich 2018; Gonzalez‐Heydrich 2010; NCT02293655; Pliszka 2000
History or diagnosis of sleep disorder 5 Corkum 2008; Corkum 2020; Murray 2011; Wigal 2004; Wigal 2011
Significant suicidality or dangerous to self or others 23 Abikoff 2009; Blum 2011; Childress 2020a; Childress 2020b; Childress 2020c; Coghill 2013; Findling 2007; Findling 2010; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Jensen 1999 (MTA); Kollins 2006 (PATS); Kollins 2021; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Pliszka 2017; Riggs 2011; Schrantee 2016; Waxmonsky 2008; Weiss 2021; Zeni 2009
Has a known history of physical, sexual or emotional abuse in the last year, or history of child abuse 5 Childress 2020a; Childress 2020c; Heriot 2008; Jensen 1999 (MTA); Kollins 2006 (PATS)
History or diagnosis of substance abuse or positive drug screening test or suspected drug abuse 41 Abikoff 2009; Arnold 2004; Biederman 2003b; Brams 2008; Brams 2012; Childress 2009; Childress 2017; Childress 2020a; Childress 2020b; Coghill 2007; Coghill 2013; Cox 2006; Findling 2006; Findling 2007; Findling 2010; Greenhill 2006; Huang 2021; Kollins 2021; Kritchman 2019; Lopez 2003; Martins 2004; Muniz 2008; Murray 2011; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Pliszka 2007; Pliszka 2017; Schrantee 2016; Silva 2005a; Silva 2006; Silva 2008; Stein 2011; Sumner 2010; Swanson 2004b; Szobot 2004; Tucker 2009; Weiss 2021; Wigal 2004; Wigal 2011; Zeni 2009
Living with a person with a current or earlier substance abuse disorder or family history of drug abuse 12 Biederman 2003b; Childress 2009; Childress 2017; Childress 2020a; Childress 2020c; Findling 2006; Greenhill 2002; Huang 2021; Jensen 1999 (MTA); Kollins 2006 (PATS); Swanson 2004b; Wigal 2003
Inability to take/swallow or tolerate methylphenidate/ingredients in the medication or history of adverse reactions/adverse events 54 Arnold 2004; Barkley 1991; Barkley 2000; Biederman 2003b; Blum 2011; Brams 2008; Brams 2012; Carlson 2007; Childress 2017; Childress 2020b; Childress 2020c; Coghill 2013; Cox 2006; CRIT124US02; Fabiano 2007; Findling 2007; NCT02039908; Gonzalez‐Heydrich 2010; Greenhill 2002; Greenhill 2006; Gruber 2007; Huang 2021; Jensen 1999 (MTA); Kent 1995; Kollins 2006 (PATS); Kollins 2021; Murray 2011; NCT02536105; Newcorn 2008; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Palumbo 2008; Pearson 2013; Pelham 2005; Pelham 2014; Pliszka 2017; Quinn 2004; Schachar 2008; Schwartz 2004; Silva 2005a; Stein 2011; Sumner 2010; Swanson 2004b; Tannock 2018; Waxmonsky 2008; Weiss 2021; Wigal 2003; Wigal 2004; Wigal 2011; Wigal 2015; Wilens 2006b; Wilens 2010; Wolraich 2001; Zeni 2009
History of failed/poor response/being non‐responsive to methylphenidate (unless naive to stimulants), or past treatment failure on a methylphenidate trial 27 Brams 2012; Childress 2020b; Childress 2020c; Coghill 2013; Fabiano 2007; Findling 2006; Findling 2010; Greenhill 2006; Kollins 2021; McGough 2006; Murray 2011; NCT02039908; Newcorn 2008; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Pearson 2013; Schachar 2008; Schulz 2010; Silva 2006; Silva 2008; Stein 2011; Tannock 2018; Wigal 2003; Wigal 2011; Wilens 2006b; Wilens 2008; Wilens 2010
Satisfied with current pharmacological treatment (if not stimulant‐naive) or having effective control of symptoms with acceptable tolerability on current ADHD medication 10 Childress 2020a; Coghill 2013; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Nikles 2006; Weiss 2021; Wigal 2013; Wigal 2014; Wigal 2015
Had been receiving methylphenidate > 6 months, or daily dose was above dose specified in the research protocol 1 Musten 1997
Previous pharmacological treatment for ADHD 23 Barragán 2017; Buitelaar 1995; Coghill 2007; Cook 1993; Corkum 2008; Corkum 2020; Flapper 2008; Froehlich 2018; Kollins 2006 (PATS); Konrad 2004; Oesterheld 1998; Perez‐Alvarez 2009; Ramtvedt 2013; Schachar 1997a; Szobot 2008; Taylor 1987; Tirosh 1993a; Tirosh 1993b; Tucker 2009; Urman 1995; Van der Meere 1999a; Wallander 1987; Zeiner 1999
Any medical/physical disease 10 Castellanos 1997; Flapper 2008; Perez‐Alvarez 2009; Pliszka 1990; Pliszka 2000; Quinn 2004; Swanson 1998; Swanson 2002a; Wilkison 1995; Zeiner 1999
Any ongoing chronic condition, or poor physical health, or somatic disorder/medical condition that could contraindicate treatment or confound efficacy or safety, or physical disability, or their medical condition affecting cognitive or neuropsychological performance 92 Barragán 2017; Bedard 2008; Biederman 2003b; Borcherding 1990; Brams 2008; Brams 2012; Brown 1985; Carlson 2007; Childress 2009; Childress 2017; Childress 2020a; Childress 2020b; Childress 2020c; Coghill 2013; Connor 2000; Cox 2006; CRIT124US02; Douglas 1995; Fabiano 2007; Findling 2006; Findling 2007; Findling 2008; Gadow 1990; Gadow 1995; Gadow 2007; Gadow 2011; Gonzalez‐Heydrich 2010; Gorman 2006; Greenhill 2002; Greenhill 2006; Hale 2011; Hawk 2018; Heriot 2008; Horn 1991; Huang 2021; Ialongo 1994; Jacobi‐Polishook 2009; Jensen 1999 (MTA); Kelly 1989; Kollins 2006 (PATS); Kollins 2021; Lin 2014; Lopez 2003; Lufi 1997; Martins 2004; Matthijssen 2019; McCracken 2016; Musten 1997; NCT00409708; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Oesterheld 1998; Pearson 2013; Pelham 2001a; Pelham 2011; Pelham 2014; Pliszka 2017; Riggs 2011; Schachar 1997a; Schachar 2008; Schulz 2010; Sharp 1999; Shiels 2009; Silva 2005a; Silva 2006; Silva 2008; Smithee 1998; Solanto 2009; Stein 2003; Stein 2011; Sumner 2010; Swanson 2004b; Tannock 1989; Tannock 1992; Tannock 1993; Tannock 1995a; Tannock 1995b; Tannock 2018; Tirosh 1993a; Tirosh 1993b; Tourette's Syndrome Study Group 2002; Van der Meere 1999a; Weiss 2021; Wigal 2003; Wigal 2013; Wigal 2014; Wigal 2015; Wigal 2017; Wilens 2008; Wilens 2010; Wolraich 2001; Zeni 2009
Cardiac abnormalities or cardiac surgery, or clinically significant abnormalities in ECG results, or family history of sudden death or long‐QT syndrome, or ventricular arrhythmia, or hypertension, or hypotension, or bradycardia, or syncope 50 Arnold 2004; Barkley 1989b; Barkley 1991; Barkley 2000; Blum 2011; Brams 2012; Buitelaar 1995; Carlson 1995; Childress 2009; Childress 2017; Childress 2020a; Childress 2020b; Childress 2020c; Coghill 2013; Döpfner 2004; DuPaul 1996; Duric 2012; Findling 2008; Findling 2010; Froehlich 2018; Lin 2014; McCracken 2016; NCT02293655; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Overtoom 2003; Palumbo 2008; Pelham 2001a; Pelham 2011; Quinn 2004; Riggs 2011; Schrantee 2016; Stein 2011; Sumner 2010; Swanson 1998; Swanson 2002a; Swanson 2004b; Tannock 1989; Tourette's Syndrome Study Group 2002; Tucker 2009; Weiss 2021; Wigal 2003; Wigal 2004; Wigal 2011; Wigal 2013; Wigal 2014; Wigal 2015; Wilens 2006b; Wilens 2010
History or evidence of renal disease or impaired renal function 6 Arnold 2004; Childress 2020c; Palumbo 2008; Quinn 2004; Tourette's Syndrome Study Group 2002; Wigal 2004
History or evidence of hepatic disease 2 Childress 2020c; Döpfner 2004
History or evidence of respiratory (other than asthma/allergy) disease 5 Arnold 2004; Buitelaar 1995; Childress 2020c; Quinn 2004; Wigal 2004
History or evidence of endocrine disease (e.g. hyperthyroidism) or insulin dependent diabetes or any metabolic disease 16 Arnold 2004; Barkley 2000; Buitelaar 1995; Childress 2020a; Childress 2020c; Corkum 2008; Corkum 2020; Greenhill 2002; NCT00409708; NCT02536105; Schrantee 2016; Swanson 2004b; Weiss 2021; Wigal 2003; Wigal 2004; Wigal 2015
History or evidence of immune disease 3 Arnold 2004; Childress 2020c; Wigal 2004
Gastrointestinal narrowing, or significant gastrointestinal problems 7 Childress 2020c; Coghill 2013; Huang 2021; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Wigal 2011; Wilens 2006b
Glaucoma 19 Blum 2011; Childress 2020a; Childress 2020c; Coghill 2013; Greenhill 2002; Huang 2021; Kent 1995; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Schrantee 2016; Swanson 2004b; Weiss 2021; Wigal 2003; Wigal 2011; Wigal 2013; Wigal 2015; Wilens 2006b; Wolraich 2001
Not within 30% of normal body weight, or outside 18/22‐59/75 kg at trial entry, or underweight or overweight or weighs less than 9 kg or 79.5 lb, or weight < 3rd percentile for age 16 Arnold 2004; Carlson 2007; Childress 2020a; Childress 2020b; Coghill 2013; Döpfner 2004; Findling 2008; Gonzalez‐Heydrich 2010; Lin 2014; Murray 2011; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Oesterheld 1998; Pearson 2013; Pliszka 2017; Wigal 2004
Pregnant or lactating or inadequate form of birth control or female who had undergone menarche 41 Barkley 2000; Biederman 2003b; Brams 2008; Brams 2012; Childress 2009; Childress 2020a; Childress 2020b; Coghill 2013; CRIT124US02; Findling 2006; Findling 2007; Findling 2008; Findling 2010; Gonzalez‐Heydrich 2010; Greenhill 2002; Greenhill 2006; McCracken 2016; Muniz 2008; NCT02293655; NCT02536105; Newcorn 2017a (flexible dose); Newcorn 2017b (forced dose); Oesterheld 1998; Palumbo 2008; Pelham 2001a; Pliszka 2017; Riggs 2011; Silva 2005a; Silva 2006; Silva 2008; Stein 2011; Sumner 2010; Swanson 2004b; Tourette's Syndrome Study Group 2002; Weiss 2021; Wigal 2003; Wigal 2004; Wigal 2015; Wilens 2010; Wolraich 2001; Zeni 2009
Abnormal laboratory parameters and/or vital signs and/or physical examination 15 Brams 2012; Findling 2008; Greenhill 2002; Greenhill 2006; McGough 2006; NCT02536105; Oesterheld 1998; Overtoom 2003; Pelham 2011; Pliszka 2017; Swanson 1998; Tucker 2009; Weiss 2021; Wigal 2015; Wigal 2017
ADHD: Attention deficit hyperactivity disorder; CD: conduct disorder; CNS: central nervous system; ECG: electrocardiogram; IQ: Intelligence quotient; ODD: oppositional defiant disorder

aSevere learning disability (defined by special education enrolment).
bExceptions: obsessive‐compulsive disorder, conduct or oppositional disorder, overanxious disorder and specific developmental disorders.
cOnly bipolar disorder, not major depressive disorder.