/ Control Response Rate / Cross-over Trials / Cumulative Distribution Function / Equivalence Trials / Evaluable Sample Size / Ich E9 / Investigative Treatment / MEDICAL / Research / multiplicity adjustment / Non-inferiority Limit / Non-inferiority Margin / Non-inferiority Study / Non-inferiority Trials / Normal Approximation Approach / Normal Approximation Confidence Interval / Parallel Group Trial / Sample size calculations / Sample Size Estimate / Sample Size Justification / Sample Size Re-estimation / Standardised Differences / statistical power analysis / Superiority Trials / survival data modeling / trial design methodology / WOMAC Physical Function