Table 4.

Summary of CID calculations

Comparisons	Meets CID criteria?*
	Anchor CID	Distribution CID
Study ALO-01-07-205 (oral dosing)
Placebo versus IRMS	Yes	Yes
Placebo versus intact ALO-01	Yes	Yes
Placebo versus crushed ALO-01	Yes	Yes
Crushed versus intact ALO-01	No	No
IRMS versus intact ALO-01	Yes	Yes
IRMS versus crushed ALO-01	Yes	Yes
Study ALO-01-07-106 (IV dosing)
Placebo versus MS	Yes	Yes
Placebo versus MS + NTX	Yes	Yes
MS versus MS + NTX	Yes	Yes

^*See Table 3 for data

ALO-01 extended-release morphine with sequestered naltrexone, CID clinically important difference, IRMS immediate-release MS, MS morphine sulfate, NTX naltrexone