Subjects had baseline 17-item Hamilton Depression Rating Scale (HamD17) ≥ 17.202 subjects comprised the intent-to-treat (ITT) sample, and 120 subjects completed treatment per-protocol (PP).
Fifty-four subjects (28 exenatide, 26 placebo) were randomized and comprised the intent-to-treat population.
A total of 491 patients comprised the intent-to-treat population (160 exenatide QW, 166 sitagliptin, and 165 pioglitazone).
All patients had failed first-line chemotherapy with a platinum-based regimen and comprised the intent-to-treat population.
Of the 628 randomized patients, 569 comprised the Intent-to-Treat (ITT) population, and 559 of these completed the study.
All patients receiving at least one dose of ridaforolimus comprised the intent-to-treat (ITT) population, and all were assessed for safety.
A total of 716 patients with type 2 diabetes and glycated haemoglobin A1c (HbA1c) ≥7.5%andd ≤10.0% were screened; 345 were randomized and 322 comprised the intent-to-treat group (premeal, 163; postmeal, 159).
Accordingly, 457 (IDeg 200 units/mL n = 228 and IGlar n = 229) and 456 (IDeg 200 units/mL n = 228 and IGlar n = 228) participants were exposed to treatment and comprised the intent-to-treat and safety populations (Supplementary Fig. 1).
RESULTS: A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin, respectively.
One hundred ninety-nine patients received ≥1 dose of study drug and comprised the modified intent-to-treat population.
