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Guideline Summary
Guideline Title
Practice parameter: treatment of nonmotor symptoms of Parkinson disease. Report of the Quality Standards Subcommittee of the American Academy of Neurology.
Bibliographic Source(s)
Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ, Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: treatment of nonmotor symptoms of Parkinson disease: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. [40 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • December 17, 2013 – Methylphenidate ADHD Medications External Web Site Policy: The U.S. Food and Drug Administration (FDA) is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. If not treated right away, priapism can lead to permanent damage to the penis.

Scope

Disease/Condition(s)

Nonmotor symptoms of Parkinson disease, including:

  • Autonomic dysfunction (gastrointestinal disorders, orthostatic hypotension, sexual dysfunction, urinary incontinence)
  • Sleep disorders (restless legs syndrome, periodic limb movements of sleep, excessive daytime somnolence, insomnia, rapid eye movement [REM] sleep behavior disorder)
  • Fatigue
  • Anxiety
Guideline Category
Assessment of Therapeutic Effectiveness
Treatment
Clinical Specialty
Family Practice
Geriatrics
Internal Medicine
Neurology
Intended Users
Advanced Practice Nurses
Pharmacists
Physician Assistants
Physicians
Guideline Objective(s)

To provide evidence-based recommendations for treatment of nonmotor symptoms in Parkinson disease

Target Population

Patients with Parkinson disease and autonomic dysfunction (gastrointestinal disorders, orthostatic hypotension, sexual dysfunction, urinary incontinence), sleep disorders (restless legs syndrome, periodic limb movements of sleep, excessive daytime somnolence, insomnia, rapid eye movement [REM] sleep behavior disorder), fatigue, and anxiety

Interventions and Practices Considered
  1. Sildenafil citrate for erectile dysfunction
  2. Isosmotic macrogol (polyethylene glycol) for constipation
  3. Modafinil for excessive daytime somnolence
  4. Levodopa/carbidopa for periodic limb movements of sleep
  5. Methylphenidate for fatigue
Major Outcomes Considered
  • Improved scores on rating scales/questionnaires
  • Changes in electronic monitoring results
  • Adverse effects of therapy
  • Quality of life
  • Morbidity

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

In November 2006, a literature search was performed (in all languages) using the search terms shown in the table in the original guideline document.

Therapies reviewed included pharmaceuticals as well as other therapies such as the continuous positive airway pressure machine in patients with sleep abnormalities, dietary modifications, homeopathic treatments, surgery, and interventional therapies such as electroconvulsive therapy.

Three databases (MEDLINE, EMBASE, and Science Citation Index) were searched from 1966 to November 2006 (with manual searches until August 2008), resulting in 3,369 citations. Each abstract was reviewed by at least 2 members of the panel for relevance for further review. Articles that evaluated treatment of a nonmotor symptom in patients with Parkinson disease (PD) were considered relevant. This resulted in a list of 523 articles, each of which was reviewed by at least 2 members of the panel for relevance. Any disagreements were arbitrated by a third reviewer. After detailed review of all 523 articles, the panel decided 46 articles contributed relevant, assessable data. Articles were excluded if they did not relate to PD or treatment of nonmotor PD symptoms or if they related to treatment of cognitive or mood disorders in PD or treatment of sialorrhea with botulinum toxin.

Number of Source Documents

46

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Classification of Evidence for Studies of Therapeutic Intervention

Class I = A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences. The following are also required:

  1. Concealed allocation
  2. Primary outcome(s) clearly defined
  3. Exclusion/inclusion criteria clearly defined
  4. Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias
  5. For non-inferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
    1. The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or non-inferiority.
    2. The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment. (e.g., for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).
    3. The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.
    4. The interpretation of the results of the study is based upon a per protocol analysis that takes into account dropouts or crossovers.

Class II = A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a–e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b–e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.

Class III = All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.**

Class IV = Studies not meeting Class I, II, or III criteria including consensus or expert opinion.

*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three is missing, the class is automatically downgraded to Class III.

**Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

The articles identified in the literature search were classified for quality of evidence based on the American Academy of Neurology (AAN) therapeutic classification scheme (appendix e-3 on the Neurology® Web site at www.neurology.org External Web Site Policy).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The American Academy of Neurology (AAN) convened an expert panel of investigators from the United States and Europe who have published extensively in the field of nonmotor symptoms in Parkinson disease. The panel was selected to represent a broad range of relevant expertise and opinion. Recommendations were based on the class of evidence (see the "Rating Scheme for the Strength of the Recommendations" field).

Rating Scheme for the Strength of the Recommendations

Classification of Recommendations

Level A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.*)

Level B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or two consistent Class II studies.)

Level C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)

Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.

*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if: 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2).

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The Quality Standards Subcommittee of the American Academy of Neurology (AAN) reviewed and approved a draft of the article. The draft was next sent to members of the Practice Committee of the AAN for further review and then to Neurology® for peer review. Boards of the AAN reviewed and approved the final version of the article. At each step of the review process, external reviewers' suggestions were explicitly considered. When appropriate, the expert panel made changes to the document.

The guideline was approved by the Quality Standards Subcommittee February 7, 2009; by the Practice Committee June 9, 2009; and by the AAN Board of Directors November 9, 2009.

Recommendations

Major Recommendations

Definitions of the levels of the recommendations (A, B, C, U) and classification of the evidence (Class I-IV) are provided at the end of the "Major Recommendations" field.

Erectile Dysfunction

Sildenafil citrate may be considered in patients with Parkinson disease (PD) with erectile dysfunction (Level C).

Orthostatic Hypotension (OH)

There is insufficient evidence to support or refute treatments of OH in PD (Level U).

Urinary Incontinence

There is insufficient evidence to support or refute treatments of urinary incontinence in PD (Level U).

Constipation

  • Isosmotic macrogol (polyethylene glycol) may be considered to treat constipation in PD (Level C).
  • There is insufficient evidence to support or refute the use of botulinum toxin to treat constipation in PD (Level U).

Excessive Daytime Somnolence

Modafinil should be considered for patients to improve their subjective perception of excessive daytime somnolence (EDS) (Level A). There is insufficient evidence to support or refute a safety benefit in patients with PD with EDS who engage in activities where sleepiness poses a potential danger (e.g., driving) (Level U). It should be noted that patients who are treated with modafinil may experience an improvement in sleep perception without an actual improvement in objective sleep measurements.

Insomnia

  • There is insufficient evidence to support or refute the benefit of levodopa on objective sleep parameters that are not affected by motor status (Level U).
  • There is insufficient evidence to support or refute the treatment of poor sleep quality with melatonin (Level U).

Periodic Limb Movements of Sleep

  • Levodopa/carbidopa should be considered to treat periodic limb movements of sleep (PLMS) (Level B).
  • There is insufficient evidence to support or refute the treatment of restless legs syndrome (RLS) and PLMS with non-ergot dopamine agonists (Level U).

Fatigue

Methylphenidate may be considered in patients with fatigue (Level C).

REM Sleep Behavior Disorder

There is insufficient evidence to support or refute the treatment of REM sleep behavior disorder (RBD) (Level U).

Anxiety

There is insufficient evidence to support or refute the treatment of anxiety in PD with levodopa (Level U).

Definitions:

Classification of Recommendations

Level A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.*)

Level B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population. (Level B rating requires at least one Class I study or two consistent Class II studies.)

Level C = Possibly effective, ineffective, or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)

Level U = Data inadequate or conflicting; given current knowledge, treatment (test, predictor) is unproven.

*In exceptional cases, one convincing Class I study may suffice for an "A" recommendation if: 1) all criteria are met, 2) the magnitude of effect is large (relative rate improved outcome >5 and the lower limit of the confidence interval is >2).

Classification of Evidence for Studies of Therapeutic Intervention

Class I = A randomized, controlled clinical trial of the intervention of interest with masked or objective outcome assessment, in a representative population. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences. The following are also required:

  1. Concealed allocation
  2. Primary outcome(s) clearly defined
  3. Exclusion/inclusion criteria clearly defined
  4. Adequate accounting for drop-outs (with at least 80% of enrolled subjects completing the study) and cross-overs with numbers sufficiently low to have minimal potential for bias
  5. For non-inferiority or equivalence trials claiming to prove efficacy for one or both drugs, the following are also required*:
    1. The authors explicitly state the clinically meaningful difference to be excluded by defining the threshold for equivalence or non-inferiority.
    2. The standard treatment used in the study is substantially similar to that used in previous studies establishing efficacy of the standard treatment. (e.g., for a drug, the mode of administration, dose and dosage adjustments are similar to those previously shown to be effective).
    3. The inclusion and exclusion criteria for patient selection and the outcomes of patients on the standard treatment are comparable to those of previous studies establishing efficacy of the standard treatment.
    4. The interpretation of the results of the study is based upon a per protocol analysis that takes into account dropouts or crossovers.

Class II = A randomized controlled clinical trial of the intervention of interest in a representative population with masked or objective outcome assessment that lacks one criteria a–e above or a prospective matched cohort study with masked or objective outcome assessment in a representative population that meets b–e above. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.

Class III = All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.**

Class IV = Studies not meeting Class I, II, or III criteria including consensus or expert opinion.

*Note that numbers 1-3 in Class Ie are required for Class II in equivalence trials. If any one of the three is missing, the class is automatically downgraded to Class III.

**Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) exception or bias (e.g., blood tests, administrative outcome data).

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate treatment of nonmotor symptoms in patients with Parkinson disease

Potential Harms

Methylphenidate has the potential for abuse.

Qualifying Statements

Qualifying Statements

This statement is provided as an educational service of the American Academy of Neurology (AAN). It is based on an assessment of current scientific and clinical information. It is not intended to include all possible proper methods of care for a particular neurologic problem or all legitimate criteria for choosing to use a specific procedure. Neither is it intended to exclude any reasonable alternative methodologies. The AAN recognizes that specific patient care decisions are the prerogative of the patient and the physician caring for the patient, based on all of the circumstances involved. The clinical context section is made available in order to place the evidence-based guideline(s) into perspective with current practice habits and challenges. No formal practice recommendations should be inferred.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
Quick Reference Guides/Physician Guides
Resources
Slide Presentation
Staff Training/Competency Material
Wall Poster
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ, Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: treatment of nonmotor symptoms of Parkinson disease: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. [40 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Apr 9
Guideline Developer(s)
American Academy of Neurology - Medical Specialty Society
Source(s) of Funding

American Academy of Neurology (AAN)

Guideline Committee

The Quality Standards Subcommittee

Composition of Group That Authored the Guideline

Guideline Authors: T.A. Zesiewicz, MD, FAAN; K.L. Sullivan, MSPH; I. Arnulf, MD; K.R. Chaudhuri, MD; J.C. Morgan, MD, PhD; G.S. Gronseth, MD, FAAN; J. Miyasaki, MD, MEd, FAAN; D.J. Iverson, MD, FAAN; W.J. Weiner, MD

Quality Standards Subcommittee Members (2007-2009): Jacqueline French, MD, FAAN (Chair); Charles E. Argoff, MD; Eric Ashman, MD; Stephen Ashwal, MD, FAAN (Ex-Officio); Christopher Bever, Jr., MD, MBA, FAAN; John D. England, MD, FAAN; Gary M. Franklin, MD, MPH, FAAN (Ex-Officio); Deborah Hirtz, MD, FAAN (Ex-Officio); Robert G. Holloway, MD, MPH, FAAN; Donald J. Iverson, MD, FAAN; Steven R. Messé, MD; Leslie A. Morrison, MD; Pushpa Narayanaswami, MD, MBBS; James C. Stevens, MD, FAAN (Ex-Officio); David J. Thurman, MD, MPH (Ex-Officio); Dean M. Wingerchuk, MD, MSc, FRCP(C); Theresa A. Zesiewicz, MD, FAAN

Financial Disclosures/Conflicts of Interest

Conflict of Interest

The American Academy of Neurology (AAN) is committed to producing independent, critical and truthful clinical practice guidelines (CPGs). Significant efforts are made to minimize the potential for conflicts of interest to influence the recommendations of this CPG. To the extent possible, the AAN keeps separate those who have a financial stake in the success or failure of the products appraised in the CPGs and the developers of the guidelines. Conflict of interest forms were obtained from all authors and reviewed by an oversight committee prior to project initiation. AAN limits the participation of authors with substantial conflicts of interest. The AAN forbids commercial participation in, or funding of, guideline projects. Drafts of the guidelines have been reviewed by at least 3 AAN committees, a network of neurologists, Neurology® peer reviewers, and representatives from related fields. The AAN Guideline Author Conflict of Interest Policy can be viewed at www.aan.com External Web Site Policy.

Disclosure

Dr. Zesiewicz has received funding for travel from and served on speakers' bureaus for Boehringer Ingelheim and Teva Pharmaceutical Industries Ltd.; and receives research support from Boehringer Ingelheim, Novartis, GlaxoSmithKline, UCLA-RAND, Teva Neuroscience, Pfizer Inc, Allergan, Inc., the National Ataxia Foundation, Friedreich's Ataxia Research Association, and from the Bill Allison Ataxia Research Center. Ms. Sullivan reports no disclosures. Dr. Arnulf has served on scientific advisory boards for UCB and BioProject Pharma; has received funding for travel from UCB and for educational activities not funded by industry; received speaker honoraria from UCB and AstraZeneca; and has received research support UCB and BioProject Pharma. Dr. Chaudhuri serves on scientific advisory boards for Solvay Pharmaceuticals, Inc., Boehringer Ingelheim, GlaxoSmithKline, Merck Serono, Teva Pharmaceutical Industries Ltd.; serves on the editorial board of Parkinson's Disease and Related Disorders; receives research support from UCB, SCHWARZ PHARMA, Boehringer Ingelheim, Britannia Pharmaceuticals, and Solvay Pharmaceuticals, Inc.; and estimates that 10% of his clinical effort is administering botulinum toxin for dystonia. Dr. Morgan serves on a scientific advisory board for Boehringer Ingelheim; serves on speakers' bureaus for Boehringer Ingelheim, GlaxoSmithKline, Teva Pharmaceutical Industries Ltd., Novartis, and SCHWARZ PHARMA; and receives research support from Boehringer Ingelheim, GlaxoSmithKline, UCB, Teva Pharmaceutical Industries Ltd., Novartis, ACADIA Pharmaceuticals, Santhera Pharmaceuticals, the NIH (NET-PD LS-1 [sub-investigator]), and from the National Parkinson Foundation. Dr. Gronseth serves as an editorial advisory board member of Neurology Now; serves on a speakers' bureau for Boehringer Ingelheim; and receives honoraria from Boehringer Ingelheim and the American Academy of Neurology. Dr. Miyasaki has served on a scientific advisory board for Teva Pharmaceutical Industries Ltd.; has received honoraria for educational activities not funded by industry; serves on the editorial board of Movement Disorders; has received speaker honoraria from Biovail Corporation; serves/has served as a consultant to Ortho-McNeil-Janssen Pharmaceuticals, Inc., Merz Pharmaceuticals, LLC, Schering-Plough Corp., the NIH (Independent Medical Monitor), Ontario Drug Benefits, and Common Drug Review, Canada; and receives research support from Teva Pharmaceutical Industries Ltd., Boehringer Ingelheim, Solvay Pharmaceuticals, Inc., Solstice Neurosciences, Inc., Impax Laboratories, Neurogen, Medivation, Inc., the National Parkinson Foundation, the Parkinson Society Canada, the Michael J Fox Foundation, and the Huntington Study Group. Dr. Iverson reports no disclosures. Dr. Weiner has served on scientific advisory boards for Santhera Pharmaceuticals, Boehringer Ingelheim, Novartis, GlaxoSmithKline, and Teva Pharmaceutical Industries Ltd.; serves as Editor of Current Treatment Options in Neurology and on the editorial board of Parkinsonism and Related Disorders; receives royalties from the publication of Parkinson's Disease: A Complete Guide for Patients and Families (The Johns Hopkins University Press, 2001), Parkinson's Disease: Diagnosis and Clinical Management (Demos Medical Publishing, Inc., 2002), and Neurology for the Non-Neurologist 5th ed. (Lippincott Williams & Wilkins, 2004); and has received research support from Santhera Pharmaceuticals, Boehringer Ingelheim, and Teva Pharmaceutical Industries Ltd.

Guideline Endorser(s)
American Academy of Sleep Medicine - Professional Association
Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: A list of American Academy of Neurology (AAN) guidelines, along with a link to a Portable Document Format (PDF) file for this guideline, is available at the AAN Web site External Web Site Policy.

Print copies: Available from the AAN Member Services Center, (800) 879-1960, or from AAN, 201 Chicago Avenue South, Minneapolis, MN 55415.

Availability of Companion Documents

The following are available:

  • Treatment of nonmotor symptoms of Parkinson disease. AAN summary of evidence-based guideline for clinicians. St. Paul (MN): American Academy of Neurology. 2010. 2 p. Available in Portable Document Format (PDF) from the American Academy of Neurology (AAN) Web site External Web Site Policy.
  • Treatment of nonmotor symptoms of Parkinson disease. Case study. St. Paul (MN): American Academy of Neurology. 2010. 4 p. Available in PDF from the AAN Web site External Web Site Policy.
  • Treatment of nonmotor symptoms of Parkinson disease. Slide presentation. St. Paul (MN): American Academy of Neurology. 2010. 67 p. Available from the AAN Web site External Web Site Policy.
  • Treatment of nonmotor symptoms of Parkinson disease. Poster. St. Paul (MN): American Academy of Neurology. 2010. 1 p. Available in PDF from the AAN Web site External Web Site Policy.
  • AAN guideline development process [online]. St. Paul (MN): American Academy of Neurology. Available from the AAN Web site External Web Site Policy.
Patient Resources

The following is available:

  • Parkinson disease: treating symptoms unrelated to movement. AAN summary of evidence-based guideline for patients and their families. St. Paul (MN): American Academy of Neurology (AAN). 2010. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the AAN Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on August 30, 2010. This summary was updated by ECRI Institute on April 7, 2014 following the U.S. Food and Drug Administration advisory on Methylphenidate ADHD Medications.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.

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