Secondary Efficacy Variables. Time until recovery, defined by date and time of the evacuation of the first of two consecutive normal stools or no stool within 12 hours. • Number of recovered subjects per treatment group in total and until each individual treatment day. Mean and median time until recovery per treatment group. • Global Physician Assessment at the end of treatment:
Secondary Efficacy Variables. Secondary end-points will be analyzed using parametric or non-parametric standard statistical methods. The proportion achieving “smoking reduction” or “smoking cessation” at the times and with the criteria specified in section 3.4.2 (Description of Assessments), will be analyzed with logistic regression modeling among eligible subjects using intent-to treat criteria and with participants who terminated the study prematurely for any reason considered to be failures. Exploratory analyses of secondary end-points will also be done on those who achieved “smoking reduction” at 24 weeks. A priori hypotheses concerning secondary end-points include that allocation to active snus will result in beneficial effects on lung function and cardiovascular biomarkers. Such effects are hypothesized to be directly related to the level of smoking reduction. Overall nicotine consumption (as measured by S-cotinine) is not expected to increase in the active snus group.
Secondary Efficacy Variables. The secondary efficacy variables and endpoints for this study are as follows: • proportion of patients achieving an SRI response at each visit during the treatment period • proportion of patients achieving a reduction of at least 4 points in the SLEDAI-2K total score at each visit during the treatment period • proportion of patients achieving a clinical SLEDAI-2K response at each visit during the treatment period, where the clinical response is defined as a reduction of at least 4 points in the SLEDAI-2K clinical score • proportion of patients achieving a BILAG-2004 response at each visit during the treatment period (no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline) • proportion of patients achieving a BILAG-2004 clinical response at each visit during the treatment period (an improvement in at least 1 category from a B score to a C or D score, with no worsening in any other category) • proportion of patients showing no worsening on a PhGA scale at each visit during the treatment period • proportion of patients achieving a reduction of 5 points in the SLEDAI-2K at each visit during the treatment period • proportion of patients achieving a reduction of 6 points in the SLEDAI-2K at each visit during the treatment period • proportion of patients achieving an SRI-5 response at each visit during the treatment period • proportion of patients achieving an SRI-6 response at each visit during the treatment period • proportion of patients showing an improvement in tender and swollen joint counts using the 28-joint count examination for pain and tenderness at each visit during the treatment period • SFI at each visit during the treatment period — time to first mild to moderate flare — incidence of mild to moderate flare — time to severe flare (NOTE: A severe flare leads to early withdrawal) • changes in the SDI over time (assessed at screening and weeks 24 and 52 (or final assessment) • absolute and relative changes in the SF-36 at weeks 12, 24, 36, and 52 (or final assessment) • proportion of patients with changes in steroid dose over time throughout the study The exploratory efficacy variables and endpoints for this study are as follows: • changes in the biomarkers anti-dsDNA Ab, C3, and C4 at each visit during the treatment period • changes in the following biomarkers at weeks 4, 12, 24, 36, and 52 (or final assessment): — XXX — anti–U1-70K snRNP Ab — anti-Sm Ab — CRP — IgG, IgM, IgA and IgE • absolute and relative cha...
