Randomization and masking
All eligible patients were randomized in a blinded, unbiased manner using Interactive Response Technology (IRT) to one of the treatment arms. The investigator or his/her delegate contacted the IRT after confirming eligibility. A participant randomization list was generated by the IRT using a validated system which automated the random assignment of participant numbers to randomization numbers. These randomization numbers were used to link the participant to a treatment arm and unique medication number. A separate medication list was produced using a validated system which automated the random assignment of medication numbers to packs containing the investigational drug(s).Randomization in Parts A and B was stratified by BMI (Asian <30 kg mIn this double-blind study, patients, investigator staff, persons performing the assessments, the Novartis clinical trial team and contract research organization (CRO) associates involved with continued direct study site conduct (or delegates) remained blinded to individual treatment allocation from the time of randomization until database lock for each study part (week 16 for Parts A and B and week 52 for Part C). Randomization data were kept strictly confidential until the time of unblinding and were not accessible by anyone involved in the study except for the PK bioanalyst. The identity of treatments was concealed using study drugs that were all identical in packaging, labeling, schedule of administration, appearance, taste and odor. Additional placebo capsules were given in active treatment groups when needed to maintain blinding.During the first interim analysis (week 8, Part A), the database was locked after ≥90% of patients completed their week 8 assessments. A Novartis pharmacometrician not involved in the clinical conduct of the study and a CRO performing the statistical analysis were unblinded to the week 8 results; this facilitated data review by the DMC. During the second (week 16, Part A) and third interim analyses (week 16, Parts A + B), Novartis and CRO associates involved in data analysis and reporting were unblinded to data. For the week 12 interim analysis of Part C data, Novartis and CRO associates involved in data management, analysis and reporting, and Novartis management, were unblinded, while Novartis and CRO associates (including field associates) involved with continued direct study site conduct, site personnel and patients remained blinded.