Major surgery within 4 weeks prior to randomization. No major surgery within 28 days prior to randomization Subject had major surgery within 4 weeks prior to randomization (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities. Major surgery within 4 weeks prior to randomization. Major surgery without full recovery or within 3 weeks before planned randomization; Major surgery within 4 weeks prior to randomization. Major surgery within 14 days before randomization. Major surgery within 28 days prior to randomization. Major surgery within 30 days prior to date of randomization. Major surgery within 4 weeks prior to Randomization Visit At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization Major surgery within 4 weeks before randomization Major surgery within 4 weeks prior to randomization had major surgery within 14 days prior to randomization Major surgery within 4 weeks before randomization; Major surgery within 28 days prior to randomization Major surgery within 2 weeks prior to randomization. Major surgery within 28 days before randomization Major surgery within 4 weeks of randomization; Have had major surgery within 14 days prior to randomization Major surgery or any anti-cancer therapy within 2 weeks of randomization Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study Have had a major surgery or significant trauma within 4 weeks of enrollment (Part 1) or randomization (Part 2). Any major surgery or open biopsy completed >= 4 weeks prior to randomization Major surgery within 14 days before randomization. Major surgery or radiotherapy within 14 days of randomization. Major surgery or invasive intervention within 4 weeks prior to randomization At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization Major surgery or radiotherapy within 14 days before randomization Major surgery within 14 days before randomization. Randomization within 12 weeks of surgery Major surgery within 4 weeks before randomization Undergone major surgery within 30 days prior to randomization Severe infection or major surgery within 4 weeks prior to randomization Any major surgery within 4 weeks of study randomization. Major surgery within 4 weeks prior to randomization. Major surgery within 30 days prior to date of randomization. Major surgery, except diagnostic tumor biopsy, within 4 weeks of randomization. Any major surgery or extensive radiotherapy within 21 days prior to randomization and crossover Major surgery (excluding kyphoplasty) within 28 days prior to randomization Major surgery within 21 days prior to randomization Major surgery (excluding kyphoplasty) within 28 days prior to randomization. Major surgery within 21 days prior to randomization. The participant has undergone major surgery within 28 days prior to randomization. Major surgery within 21 days prior to randomization Major surgery ? 28 days prior to the date of Randomization; patient must have complete recovery from surgery