Table 1.

Study schedule and assessments.

Item		Prestudy		Double-blind, placebo-controlled study			Washout	Early termination
		Screening (T-1)	Registration	T0 (0 week)	T1 (4 weeks)	T2 (8 weeks)	T3 (16 weeks)
Enrollment
	Written consent	✓
	Patient characteristics	✓
	Screening tests	✓
	Registration		✓
Assessment
	Handgrip strength			✓	✓	✓	✓	✓
	Quantitative muscle test			✓	✓	✓	✓	✓
	Timed walk test			✓	✓	✓	✓	✓
	Rise from bed test			✓	✓	✓	✓	✓
	Tongue pressure			✓	✓	✓	✓	✓
	Modified QMG scorea			✓	✓	✓	✓	✓
	Dual-energy X-ray absorptiometry			✓		✓	✓	✓
	Respiratory function test			✓		✓		✓
	ALSFRS-Rb (Japanese version)			✓		✓		✓
	SBMAFRSc			✓		✓		✓
	SDQd (Japanese version)			✓		✓		✓
	SWAL-QOLe (Japanese version)			✓		✓		✓
	ALSAQ-5f (Japanese version)			✓		✓		✓
	MFI-20g (Japanese version)			✓		✓		✓
	Urinary 8-OHdGh			✓		✓	✓	✓
	Serum creatine/creatinine			✓	✓	✓	✓	✓
	Urinary creatine/creatinine			✓		✓		✓
	Subjective/objective concomitant symptoms			✓	✓	✓	✓	✓
Laboratory test
	Blood test			✓	✓	✓	✓	✓
	Biochemical test	✓		✓	✓	✓	✓	✓
	Urine test			✓	✓	✓	✓	✓
	Blood pressure, body weight			✓	✓	✓	✓	✓
	Serum testosterone	✓
	Genetic testi (CAG repeat length)			✓

^aQMG score: Quantitative Myasthenia Gravis score

^bALSFRS-R: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale

^cSBMAFRS, Spinal and Bulbar Muscular Atrophy Functional Rating Scale

^dSDQ: Swallowing Disturbance Questionnaire

^eSWAL-QOL: Swallowing Quality of Life Questionnaire

^fALSAQ: Amyotrophic Lateral Sclerosis Assessment Questionnaire

^gMFI: Multidimensional Fatigue Inventory

^h8-OHdG: 8-hydroxydeoxyguanosine

ⁱRe-examination under the same conditions.