Table 1. Definitions of Study Populations and Outcomes Among Participants With Cellulitis Treated With Cephalexin Plus Trimethoprim-Sulfamethoxazole or Cephalexin Plus Placebo^a.

Study Population	Description	Outcome Definition
Per protocol	Participants who either took ≥75% of the total doses of study medication during the first 5 d and had an in-person test-of-clinical-cure visit or were determined to have had clinical failure before the test-of-cure visit and received ≥75% of the doses provided during the first 48 h of the treatment period	Participants were considered to have had a clinical cure if they did not meet the criteria for clinical failure at or before the test-of-clinical-cure visit. The criteria for clinical failure were as follows: fever (attributable to the infection), increase in maximal dimension of erythema by >25% from baseline, or worsening of swelling and tenderness by on-treatment visit (day 3 or 4); fever, no decrease in maximal dimension of erythema from baseline, or no decrease in swelling or tenderness by end-of-treatment visit (days 8-10); and fever or more than minimal erythema, swelling, or tenderness by the test-of-clinical-cure visit (days 14-21).
Modified intention to treat 1	Participants who took ≥1 dose of study medication and had an in-person or telephone assessment at the test-of-cure visit, as well as those who withdrew from the trial, were lost to follow-up before final classification, or had missing or unassigned outcomes	Participants were considered to have had a clinical cure if they did not meet the criteria for clinical failure (see examination criteria above) at or before the test-of-cure visit or based on no change in antibiotic therapy due to persistence or worsening of infection based on study clinician assessment, the participant’s assessment, or assessment by an outside clinician. Participants who withdrew from the trial, were lost to follow-up before final classification, or had missing or unassigned outcomes were classified as having had clinical failure.
Modified intention to treat 2	Participants who took ≥1 dose of study medication and had an in-person follow-up evaluation at any time during the study	Participants were considered to have had a clinical cure if they did not meet the criteria for clinical failure (see examination criteria above) at or before the last recorded follow-up visit.
US Food and Drug Administration guidance early end point	Participants who took at ≥1 dose of study medication and completed the follow-up evaluation at 48 to 72 h after the start of treatment	A clinical cure was defined by a decrease or no increase in the length, width, and area of erythema from baseline, no worsening in swelling or induration, and absence of fever (ie, temperature <37.7°C [<99.9°F]) on the basis of a trial clinician’s assessment.
Safety	Participants who underwent randomization, received study medication, and did not return 100% of the doses	Adverse events were coded according to the Medical Dictionary for Regulatory Activities, Version 17.0. Investigators categorized adverse events as related or not related to the study medication.

^aThese criteria were developed by investigator consensus.