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. 2007 Jan 24;2007(1):CD002829. doi: 10.1002/14651858.CD002829.pub4

Lange 1998.

Methods Randomized, placebo controlled, double‐blind study 
 Duration: 6 months
Participants Country: USA 
 Multicentre: 2 sites 
 Diagnosis: criteria for classical ALS 
 Number of participants: 133 (67 treated, 66 placebo, 62% male) 
 Age: mean 57 years 
 Inclusion criteria: 25 to 65 years, symptom duration less than 3 years, mild to moderate disease with Appel ALS total score 30 to 80, no drug therapy for at least 3 months before enrolment 
 Exclusion criteria: multifocal motor neuropathy with conduction block, paraproteinemia, elevated GM1 antibodies, sensorimotor peripheral neuropathy, previous infection with poliovirus, lower motor neuron disease only, primary lateral sclerosis, previous allergy to selegiline, abnormal endocrinology, serious medical problems, poor family support
Interventions 1. selegiline 5 mg twice daily 
 2. placebo
Outcomes Primary: rate of change of Appel ALS (AALS) total score 
 Secondary: AALS component scores, survival analysis
Notes Subjects with AALS score below 115 or forced vital capacity below 39% predicted were considered treatment failures and entered an open‐label phase
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: not addressed
Allocation concealment (selection bias) Unclear risk Comment: not addressed
Blinding (performance bias and detection bias) 
 All outcomes Low risk "The research team at each site consisted of 2 investigators and a study coordinator unaware of randomization status and another investigator who reviewed laboratory data."
Comment: appears adequate
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: not addressed
Selective reporting (reporting bias) Low risk Comment: appears adequate
Other bias Low risk Comment: appears adequate