Table 3.

Recommended criteria for the conduct of any new phase II or phase III pharmacological trial in sarcopenia

	Phase II trials	Phase III trials
Appropriate study design	RCT, placebo-controlled double blind	RCT, placebo-controlled double blind
Inclusion criteria	Age 70 and +	Age 70 and +
	Able to walk	Able to walk
	Low muscle strength + low physical performance	Low muscle strength + low physical performance
Exclusion criteria	Severe malnutrition	Severe malnutrition
	Acute immobility	Acute immobility
	Specific advanced pathologies	Specific advanced pathologies
	Physical limitation attributable to a specific disease other than sarcopenia	Physical limitation attributable to a specific disease other than sarcopenia
Primary outcome	See list on Table 2	Co-primary endpoint: 1/incidence of inability to walk the 400-m walk test + 2/PROM
Secondary outcome	See list on Table 2	Muscle strength (JAMAR dynamometer)
		Muscle mass (DXA)
Length of treatment/follow-up	6 months of treatment and follow-up	1 year of treatment and follow-up
Time point assessment	Every 3 months	Every 3 months but at least every 6 months
Comparator	Placebo	Placebo
Co-treatment	Standard care for both groups	Standard care for both groups
Confounding	Nutritional status	Nutritional status
	Physical activity	Physical activity
	Co-prescriptions	Co-prescriptions
	Comorbidities	Comorbidities
	Health events	Health events
Stratification	Value of primary outcome at baseline	Value of primary outcome at baseline
	Gender	Gender
	Age	Age
	Comorbidities	Comorbidities
	Frailty status	Frailty status
	Variable intervened	Variable intervened
Rescue medication	NA	NA